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National Institute on Drug Abuse

Behavioral Therapies Development Program - Basic Research and Development


Research Project Grant (R01)

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Treating Nicotine Addiction in Pregnancy

Johnson, Karen; University of Tennessee at Memphis

This is a two year feasibility study that randomized 60 pregnant women who are smokers to one of two interventions: nicotine patch in conjunction with a behavioral smoking-cessation program or a behavioral smoking-cessation program alone (30 in each group). No placebo patch group was used.


Treatment of Cocaine Abuse and Attention Deficit Disorder

Kleber, Herbert; New York State Psychiatric Institute

Cocaine abuse remains a major public health problem with as yet no definitive behavioral or pharmacologic approach for its treatment. This may relate to the heterogeneity of the population. This project comprehensively addresses one possible subgroup, cocaine abusers with adult attention deficit hyperactivity disorder (ADHD). This group may represent a significant minority of cocaine abusers who may be responding differently to cocaine. Since estimates of this group have ranged from 5-35% of treatment seekers, a comprehensive diagnostic study of this disorder will be carried out in three ethnically different cocaine abuse treatment-seeking populations to shed additional light on the prevalence of this disorder. At the same time, this group will be carrying out a double-blind, placebo-controlled study using two medications that have been found useful to treat ADHD in adolescence (methylphenidate and desipramine). The twelve-week outpatient trial will look at the efficacy of these medications combined with a manual-controlled relapse prevention method using treatment retention, cocaine use and cocaine craving, and reduction of ADHD symptoms as major outcomes. A six-month follow-up will be done to assess the stability of any changes.

Clinical reports have suggested that some cocaine abusers with ADHD have a paradoxical reaction to cocaine, similar to the effect that adolescents with this disorder have when they take stimulants. However, no laboratory studies have been done to substantiate this observation. A unique aspect of this project will be the ability to directly compare, under controlled laboratory conditions, the subjective and physiologic effects of acute cocaine doses, as well as the choice/self-administration of cocaine (versus a non-drug option), in cocaine abusers, with and without ADHD. Additionally, the effects of methylphenidate and desipramine pretreatment on these responses will also be addressed in the laboratory. This combination of novel treatment strategies, innovative laboratory investigations, and epidemiologic studies should significantly advance knowledge of a potentially important subgroup of cocaine abusers, and aid in important medication development efforts for the treatment of cocaine abuse.


Buprenorphine Maintenance for Opioid Addicts

Kosten, Thomas; Yale University

In this recently completed randomized clinical trial, low dose buprenorphine (BUP) up to 6 mg daily has shown limited efficacy for opioid or cocaine abuse, but in a dose ranging study it was found that 1216 mg sublingual BUP daily reduced both opioid and cocaine abuse. In a related study this group has shown some efficacy for desipramine (DMI) in cocaine abusing methadone (METH) treated patients, particularly those with depression. The DMI response has been poorer in METH than in non-METH cocaine abusers, possibly because METH interferes with DMI metabolism. This metabolic interference is stronger in women than men, although treatment response in women, particularly at six month follow-up after stopping DMI, is better than in men. This is a critical issue, since work by Dr. Arndt in male veterans has suggested a worse follow-up outcome with DMI than with placebo. Thus, both sex and depression may be important prognostic variables.

This project is a 24 week double blind, randomized clinical trial in 160 cocaine and opioid dependent patients. Four 40 patient cells are compared: 1. BUP (16 mg) + DMI (150 mg), 2. BUP + placebo, 3. METH (65 mg) + DMI, 4. METH + placebo. During the 24 weeks patients will remain on either METH or BUP (double dummy), but for DMI a 12 week counterbalanced, crossover design will be used to increase statistical power and facilitate analyses by gender and depression status. It is hypothesized that the combination of DMI + BUP will be more effective than either agent alone, and that depressives and women may respond best. This results from the generally better response to DMI in depressives and from the lack of interference with DMI metabolism by BUP compared to METH in women.


Levels of "Intervention" For Engaging Cocaine Abusers

Landau, Judith; University of Rochester Medical Center

The vast majority of individuals who are dependent on cocaine do not become involved in treatment. This has become a topic of considerable concern, especially since cocaine abuse is increasingly being associated with the spread of AIDS. This project will address this concern by explicating, standardizing, pilot testing and refining a method for engaging resistant cocaine-dependent individuals in treatment. The method has been developed over the past seven years and involves the use of family members and significant others to induct the cocaine abuser. Termed the Albany-Rochester Interventional Sequence for Engagement (ARISE), it is designed to maximize patient recruitment, while minimizing the amount of time and energy required of staff. Preliminary data indicate that ARISE is successful for the majority of reluctant cases. The purpose of this project will be to bring ARISE to the point where it can be used in clinical trials and generalizable to different programs. The project will initially involve a collaboration among the principals who developed and contributed to the ARISE method toward construction of a manual, accompanied by a three-volume reference guide, one volume for each of ARISE's three levels (the last of which is a modified Johnson Institute "Intervention"). Nine to ten families who went through the process will be interviewed for their suggestions for improving the ARISE process. The second phase of the project will be to teach ARISE to eight uninitiated senior counselors. These people will then pilot test it on 60 cases in which significant others, who desire to get a cocaine abuser into treatment, have called in. The pilot and adherence testing will be done at two different outpatient clinics in two cities. The method will then be revised and refined and a training videotape produced to accompany the written material. The training aids that issue from the project will be ready for application in a standardized way in a clinical trial. The method is also anticipated to be of use to both outpatient and inpatient programs, as well as outreach efforts.


Developing a Rural Behavioral Therapy - Stage I

Leukefeld, Carl; University of Kentucky

Rural communities, like urban communities, experience problems associated with drug abuse and drug dependence (Edwards, 1992). However, existing treatment interventions are not tailored for rural settings (Leukefeld, Clayton and Meyers, 1992). The overall aim of this three year project is to modify an existing social skills behavioral therapy for rural populations (Monti et al. 1989), refine the therapy, develop a manual, train and supervise therapists, and pilot test the structured behavioral outpatient rural therapy to treat rural drug abusers and drug dependents as Stage I Research for NIDA's Behavioral Therapies Development Program.

Year one and part of the second year will involve rural treatment program therapists, university clinical staff, recovering patients, and the project team in modifying the existing behavioral therapy for use with rural drug abusers/dependents. A focus group will be convened by project staff to develop an initial draft manual. In year two instrumentation will be finalized after preliminary testing. The draft manual will also be finalized for the pilot test. Therapists will be selected competitively for the pilot test. Manual training will be given to therapists selected to be involved in the comparative pilot test. In year three therapies will be delivered by manual trained therapists in three rural Eastern Kentucky sites. At least one day of on-site therapist supervision will be given monthly and supervision sessions will be provided weekly during the comparative pilot test in year three. A total of 114 rural Eastern Kentucky patients who meet DSM-IV criteria for drug abuse/dependence will enter the comparative pilot test. With a drop out rate of about 20%, this will assure 90 patients (15 patients per site per group) with 45 patients in each of the two groups (therapy as usual and the social skills behavioral therapy) for data analysis. The level of psychiatric severity assessed will be included as a variable for the analyses as will the presence or absence of antisocial personality. Patients will be matched by gender, race-ethnicity, and educational level. Patients will be 21 to 65 years of age and will be equally represented by gender with 50% minority representation.


Treatment of Drug Abusers with Borderline Personality

Linehan, Marsha; University of Miami

The general aim of this project is to develop an effective treatment intervention for individuals who meet criteria for both drug use disorders and for borderline personality disorder (BPD). Specific aims are to pilot test and modify as needed an existing cognitive behavioral treatment (Dialectical Behavior Therapy; DBT) which has been shown to be effective for severely dysfunctional, chronically suicidal women who meet criteria for BPD. The investigators will also develop and pilot an assessment battery for evaluating treatment with this population. To accomplish these objectives, they plan to conduct a one year pilot treatment outcome study with approximately 20 subjects meeting criteria for both drug use disorder and for BPD. Subjects will be randomly assigned to a DBT pilot treatment condition (n=10) or to a community treatment-as-usual (TAU) condition (n=10). Outcomes targeted and measured will include reductions in frequency and severity of substance abuse, suicidal behaviors, therapy-interfering behaviors, dysfunctional behaviors (other than substance abuse and suicidal behaviors) that severely limit the quality of life and negative affect and enhancement of general functioning and interpersonal skills. DBT therapists will be the Principal Investigator (PI) as well as experienced psychotherapists and drug abuse counselors trained in DBT by the PI. The major outcome assessment battery will be administered at pre-, 4-month, 8-month, and 12-month points (immediately following the end of treatment) treatment points. Additional daily patient ratings, weekly client and therapist ratings by DBT subjects and random drug testing for all subjects will be conducted. Observation of treatment sessions (through one-way mirrors and by video), weekly case consultant meetings, and ongoing assessments will be used to monitor and document treatment delivery and make necessary changes to the treatment and assessment protocols.


Enhanced Cognitive Behavioral Treat. for Cocaine Users in MMTPS

Magura, Stephen; National Development and Research Institutes, Inc.

The current study is implementing and evaluating an innovative treatment that addresses the continuing problem of cocaine use, including cocaine injection and crack use among the methadone population. Neurobehavioral treatment was modified to take into account the specific psychological vulnerabilities of a disadvantaged inner-city methadone population. Therapeutic techniques designed to improve retention have enabled about two-thirds of study patients to complete six months of what is termed "enhanced cognitive behavioral treatment." Enhanced treatment patients, as compared with randomly assigned controls, have declined in cocaine use, heroin use, and drug injection; and improved in psychological status.

The objectives of this project are: (1) To replicate the study's enhanced cognitive-behavioral treatment model at a second inner-city methadone maintenance program; (2) to integrate the innovative treatment model into ongoing methadone clinic practice; (3) to evaluate the effectiveness of the model by conducting a controlled clinical trial of patient outcomes, and (4) to determine the patient characteristics and treatment process variables that may help predict outcomes. Dually-addicted (opiate- and cocaine-dependent) new admissions to methadone maintenance will be randomly assigned to one of three methadone clinics offering enhanced cognitive-behavioral treatment (N=252) or to one of three clinics with standard methadone treatment (N=168). Patients will progress from high intensity therapy (provided by one specialist in each clinic) to moderate intensity therapy and maintenance therapy (both provided by regular methadone counselors who will be trained and supervised in using the model). Patient outcomes measured at 4, 8 and 12 months after admission will be cocaine use, heroin use, drug injection, HIV risk behaviors, social productivity, criminality and psychiatric status. Additional analysis will examine the effects on outcomes of treatment process variables such as daily attendance rate, length of treatment, adjunct and supplementary services received; patient/therapist relationship; patient satisfaction; staff attitudes; and critical events during treatment. A Manual for Enhanced Cognitive-behavioral Treatment will be produced to enable any methadone program to train clinic staff and to implement the model in ongoing clinic practice.


Aftercare for Cocaine Patients: Effectiveness and Costs

McKay, James; University of Pennsylvania

There is considerable evidence that treatment for cocaine addiction can lead to significant improvements in substance use and psychosocial problem severity. However, a significant percentage of patients relapse to cocaine abuse or dependence after primary treatment has ended. In some programs, patients are therefore referred to aftercare in an effort to prevent relapse and decrease the probability of additional rehabilitation treatments. Given the enormous social costs of cocaine addiction and the comparatively small resources for treatment, the appropriate use of aftercare could potentially have a large economic impact. However, there have only been a few studies of aftercare for cocaine patients. In particular, there is very little empirical information on the effectiveness of aftercare compared to minimal or no aftercare.

Furthermore, there is virtually no information on the cost-effectiveness of aftercare for cocaine patients. In this health services study, which builds on findings generated from a previous NIDA-funded cocaine aftercare study, this group proposes to evaluate the effectiveness and cost-effectiveness of three approaches to aftercare.

Cocaine dependent patients who complete day hospital rehabilitation will be randomly assigned to one of the following interventions: (1) Minimal aftercare (MIN), a combination of referral to self-help groups and brief telephone case management; (2) Standard disease model aftercare counseling (STND), provided through two group therapy sessions per week; and (3) Individualized aftercare (IND), provided through one individual cognitive-behavioral, relapse prevention session and one group therapy session per week. Each aftercare intervention will be 12 weeks in duration. Patients will be followed up at 3, 6, 9, 12, 18, and 24 months post intake into aftercare. follow-up assessments will include measures of drug and alcohol use (self-report, collateral reports, and urine toxicology), HIV high-risk behaviors, psychosocial problem severity, and utilization of health and social services.

In the analyses to determine treatment effectiveness, outcomes are predicted to be best in IND, followed by STND and MIN, with the difference between IND and STND increasing over the course of the follow-up. With regard to patient-treatment matching, patients who do not achieve consistent abstinence in IOP are predicted to have differentially better outcomes in IND than in STND or MIN, and those with high psychiatric severity will have differentially better outcomes in IND and STND than in MIN. Two secondary matching hypotheses will also be examined.

For the cost-effectiveness component of the project, they will assess aftercare costs, other health costs (e.g., additional inpatient and outpatient treatment), and other economic costs (e.g., medical, crime, accidents, productivity). These data will be used to perform a comprehensive analysis of the cost-effectiveness of aftercare for cocaine patients. Furthermore, the cost-effectiveness of different approaches to aftercare for specific subgroups of patients will be determined. Overall, the STND condition is expected to be the most cost-effective form of aftercare. However, it is expected that MIN aftercare will be cost-effective for low problem severity ("good prognosis") patients, whereas IND aftercare will be cost-effective for high problem severity ("poor prognosis") patients.


Modeling And Modifying Motivation For Change

Miller, William; University of New Mexico, Albuquerque

A widely recognized obstacle in treating drug dependence is apparent lack of client motivation for change. Yet there is no current consensus regarding how best to measure and modify such motivation. This project aims to clarify the construct structure of motivation for change in drug abuse/dependence, and simultaneously to test the efficacy of a promising therapeutic procedure for enhancing motivation. The project also represents a novel merger of clinical research and basic science regarding the psycholinguistics of commitment, focusing on verbal interactions of clients and therapists. A series of four studies will be conducted with clients presenting for outpatient or inpatient treatment for drug problems. The first three are randomized trials of motivational enhancement therapy (MET), a procedure shown in a series of prior trials to be effective in reducing alcohol use and problems when administered prior to or in lieu of treatment. The target populations for these three trials are female outpatients, male outpatients and inpatients entering drug abuse treatment programs at UNM-CASAA or the Albuquerque V.A. Medical Center. Subjects will be randomized to receive or not receive a MET intervention prior to entering treatment. A fourth study will examine the impact of a potentially cost-effective group form of MET. Through the use of an extensive common pretreatment assessment battery, these samples can also be combined to conduct factor and cluster analyses of motivational constructs. Psycholinguistic analyses will be conducted with natural language usage of subjects regarding their drug use and desire for change, following on interesting prior findings regarding the language of commitment. Follow-ups will be conducted at 3 months (when maximal impact is expected) and at 6 and 12 months (to determine the maintenance of prior changes and the longer-term impact of interventions). A series of secondary multivariate analyses will be conducted to determine which (among seven) motivational domains optimally predict client behavior change (e.g., treatment compliance, drug use outcomes), and to determine "matching characteristics that mark differential responsiveness to MET. Beyond a clear evaluation of the efficacy of MET, the study will contribute new knowledge regarding the structure, impact, and measurement of client pretreatment motivational characteristics, and may yield measurement and intervention tools of practical importance in the treatment of drug problems.


Unilateral Family Intervention for Drug Problems

Miller, William; University of New Mexico, Albuquerque

This development and pilot evaluation project is aimed at reaching drug dependent individuals through unilateral family intervention with their concerned significant others (CSOs). Although a variety of strategies for counseling CSOs has been widely used in practice, none has been adequately evaluated, and their outcomes are unknown. Further, currently practiced approaches have been largely atheoretical and suggest divergent, even diametrically opposed strategies. Effective intervention through CSOs is likely to: (a) benefit both drug dependent people and their CSOs, as well as their relationships and families; (b) facilitate earlier treatment for or change in drug problems; and, (c) provide CSOs with skills for exerting ongoing positive influence following any intervention or treatment. Three interrelated treatment technologies would be developed through the project: (1) a CSO skills-training strategy derived from Dr. Azrin's operant "community reinforcement approach" for engaging unmotivated individuals in treatment, which may be particularly appropriate for Hispanic clients (Phase I); (2) adaptation of existing assessment methodologies to evaluate drug problems through CSOs; and, (3) a motivational counseling strategy for initiating and consolidating change (Phase II), once contact has been established with an identified patient (IP). Evaluation will address the impact of intervention on the CSO's general functioning, on the IP's drug use and related problems, on treatment-seeking for drug problems, and on family happiness and adjustment including healthcare utilization. Key analyses focus on the impact of these strategies, as well as hypothesized markers of favorable response. A range of secondary analyses will be conducted, including coding of session videotapes to clarify processes underlying response to Phase I and Phase II modalities.


Group Cognitive-Behavior Therapy & Dual Diagnosis of Women

Najavits, Lisa; McLean Hospital

The study arises from the need to develop effective treatment for women with comorbid posttraumatic stress disorder (PTSD) and substance use disorder (SUD). Women with PTSD are estimated to comprise 29% to 59% of SUD treatment samples, and are documented to show a more severe course than women with either disorder alone. As yet, no effective treatment for this substantial population has been identified. To attend to this problem, this group has developed a treatment manual explicating a new, cognitive behavioral group therapy specifically adapted to their clinical needs as part of a Stage 1 treatment project of the NIDA Behavioral Therapies Development Program. This 24session, highly structured program offers an intensive rehearsal of cognitive behavioral, and interpersonal coping skills, using techniques empirically validated in the educational literature to make the treatment accessible and engaging for this population. It is cost-sensitive (i.e., a group format), has been revised on the basis of actual experience and empirical results of its impact, and targets topics believed most central for such women (e.g., HIV risk). Its primary goal is abstinence from all substances. Initial empirical results of its impact, based on 17 patients, show statistically significant and clinically meaningful improvements in several areas: (a) in substance use as early as one month into treatment and lasting through a 3-month follow-up, (b) in PTSD symptoms; and in the domain most theoretically relevant to the treatment, cognitions. Attendance was high (67% of available sessions), and ratings of alliance and satisfaction with the treatment were very strong.

The study is designed to take this promising treatment to the next logical level of Stage 1 evaluation that is, against a "treatment-as-usual" control group. To maximize the usefulness of such a control group in testing the effects of the CB treatment, all patients will be restricted in the amount and types of treatments they may attend while participating in this study. The target sample is 25 patients each in the treatment and control conditions. The study will: (a) estimate the effect size of the treatment compared to the control, using reduction in substance use as the primary outcome measure; (b) test the manual using expected "consumers of it (four therapists independent of the investigators); (c) evaluate patients monthly through a 9-month post-treatment follow-up period to assess maintenance of gains; and (d) psychometrically validate two new instruments that are theoretically derived from this treatment (a therapist adherence scale, and a patient "core components of treatment" scale that attempts to measure hypothesized mechanisms of action of the treatment).


Motivation and Patch Treatment for Underserved Smokers

Niaura, Raymond; Miriam Hospital

This project will test, in combination with the nicotine patch, the incremental efficacy of a maximal, tailored and sustained behavioral treatment during a minimal intervention trial. Interventions will be delivered through primary care medical clinics. The population comprises low income, less educated smokers who vary in their level of motivation to quit smoking. Patients (n=876) will be randomly assigned within primary clinics to one of two interventions: (a) TNP prescription plus brief physician advise and follow-up (minimal care); and (b) TNP prescription, brief physician advice and follow-up, with the addition of a tailored Motivational intervention, a behavioral skills counseling session for smoking cessation, and continued telephone counseling (maximal care). This study is the first to evaluate the efficacy of increasing intensity of behavioral treatment in combination with TNP in a low income Medicaid population in a primary care medical setting.


LAAM with Behavioral Treatment for Opioid/Cocaine Abuse

Oliveto, Alison; Yale University School of Medicine

Although levo-alpha-acetylmethadol (LAAM), a derivative of methadone, has been successfully used as an alternative to methadone maintenance in opioid addicts, its effect on concurrent opioid and cocaine abuse has not been ascertained. Thus, this study will examine the clinical efficacy of low- and high-dose LAAM maintenance on opioid and cocaine use in opioid-dependent cocaine abusers. In addition, since contingency management procedures have demonstrated some success in decreasing cocaine use in cocaine-abusing individuals. This study will also examine the clinical efficacy of the presence or absence of contingency management procedures targeting illicit drug use. One hundred sixty male and female opioid-dependent cocaine abusers will be stratified by sex and randomly assigned to one of four treatment groups according to a 2 x 2 experimental design: low-dose LAAM (99 mg/wk) with adjunct contingency management procedures; low-dose LAAM (99 mg/wk) without adjunct contingency management procedures; high-dose LAAM (330 mg/wk) with adjunct contingency management procedures; and high-dose LAAM (330 mg/wk) without adjunct contingency management procedures. The duration of the study will be 24 weeks, with LAAM being administered on a thrice-weekly (MWF) basis. Subjects are inducted onto LAAM during weeks 1-3 and then maintained on their assigned maintenance dose (99 mg/wk or 330 mg/wk) through week 24. During maintenance, the Friday dose will be 1.3 times greater than the Monday and Wednesday dose. At the conclusion of the study, subjects undergo detoxification from LAAM over a 4-week period. For those in the contingency management procedure group, each drug-free urine submitted will result in a voucher worth a certain monetary value that increases for consecutively drug free urines (weeks 112) or a monetary voucher with a fixed value (weeks 13 24). Subjects not assigned to the contingency management procedure will receive monetary vouchers (weeks 124) according to a yoked-control schedule (that is, not contingent upon illicit drug abstinence). Vouchers can be exchanged for mutually agreed upon goods and services at any time during the study. Outcome measures will include treatment retention, 2) illicit drug use, 3) self-reported adverse and opioid withdrawal symptoms, and 4) psychosocial functioning. follow-up interviews at nine months and/or one year post-study entry will be conducted to determine status posttreatment. Prognostic factors (i.e., sex, posttraumatic stress disorder, and depression), will also be examined in relation to treatment outcome and posttreatment status. These Findings will assist in developing more effective strategies in treating individuals with combined cocaine and opioid dependence.


CBT For Illicit Drug Use In Methadone Treated Patients

Pollack, Mark; Massachusetts General Hospital

Despite the application of treatments that combine methadone administration, weekly counseling, and contingency reinforcement strategies, many opiate dependent patients continue a pattern of illicit drug use. The purpose of this 3 year study is to fully develop and provide preliminary evidence supporting the usefulness of a novel cognitive-behavioral treatment designed to reduce illicit drug use among patients receiving methadone treatment. The treatment targets reduction of sensitivity to interoceptive cues associated with drug craving using interoceptive exposure and cognitive restructuring interventions; the treatment is termed, cognitive-behavior therapy for interoceptive cues (CBT-IC). The first year of the study will be devoted to the refinement of the treatment interventions and the development of a treatment manual. In the second and third years of funding, the standard treatment plus the CBT-IC program will be pilot tested against a program of standard clinical treatment. The two programs will be equated for therapist contact, assessment time, and contingency reinforcement strategies. Reduction in illicit drug use will serve as the primary dependent measure. The results of this study will provide pilot data on the effect size for the novel CBTIC program relative to standard clinical treatment, and the feasibility of the study procedures, including the recruitment, retention, and assessment of opiate dependent patients. Once validated, this novel treatment emphasizing interoceptive exposure and cognitive restructuring may have application to a variety of drug abuse and dependence conditions.


Behavioral/Cognitive Behavioral Trial for Cocaine Abuse

Rawson, Richard; Matrix Center

The development of empirically supported behavioral and cognitive behavioral strategies for the treatment of cocaine abuse disorders is an important addiction research priority. Two studies will evaluate two promising approaches, relapse prevention (RP) and contingency management (CM), for the treatment of cocaine abuse with two populations. Study 1 will compare RP and CM, alone and in combination, for the treatment of primary cocaine abusers. One hundred eighty (180) cocaine abusers will be randomly assigned into one of 3 groups with either an RP procedure (n=60), a CM procedure (n=60) or a combination of RP and CM procedures (n=60). The RP condition will consist of three RP sessions per week for 12 weeks followed by two RP sessions per week for an additional 12 weeks. The CM program will involve an identical schedule of clinic visits as the RP condition. The CM procedure will involve the establishment of a graduated system of positive reinforcement vouchers delivered to Ss upon achievement of cocaine negative urine samples. Study 2 will compare RP and CM alone and in combination as treatment methods for cocaine-abusing methadone patients. The design of this study will be a 2x2 (RP by CM), with treatment cells consisting of the 3 conditions described in study 1 and, in addition, a condition which involves methadone maintenance treatment as usual, with no specific intervention for cocaine abuse. Two hundred (200) cocaine-abusing methadone patients will be randomly assigned to one of four treatment conditions (n=50 per condition). In both studies, the following types of data will be collected: Demographic information and drug use history; psychiatric diagnosis (SCID); measure of treatment motivation and readiness (CMRS); self report of drug and alcohol use (time line followback); multidimensional behavior change measure (ASI); a measure of prosocial behavior change (BCI); physical measures of drug and alcohol use (urinalysis and breath alcohol results); HIV risk behaviors; retention rates in treatment; composite score of treatment effectiveness (TES). The two studies will greatly expand the knowledge on the value of RP and CM for the treatment of cocaine abuse with two important cocaine-abusing populations.


Assertive Outreach for Substance Dependent Mentally Ill

Rosenthal, Richard; Beth Israel Medical Center

This study will continue the effort to identify the necessary and sufficient features of treatment services for patients with co-occurring addictive and psychiatric disorders. This heterogeneous group is understudied and little is known about what combinations of alcohol, drug abuse, and mental health services are most appropriate. This group has begun to characterize a subgroup of patients with concurrent DSM-III-R psychoactive substance use disorders and schizophrenia (PSUD/S). This group has developed an outpatient program of integrated psychiatric and substance abuse treatment (Combined Outpatient Psychiatric and Addictive Disorders program, or COPAD). With the COPAD model, this group successfully retained 69.7% of PSUD/S patients in treatment at 4 months and 60.6% at 8 months, significantly more than those retained in a standard, non-integrated treatment program. Despite better treatment retention, the COPAD program had a considerable number of treatment non-starters.

A prospective, randomized clinical trial that tests the efficacy of two manual-driven modes of integrated substance abuse and psychiatric outpatient treatment will be conducted. In a component control design, this group will 1) to develop a model of Targeted Assertive Outreach (TAO) particularly designed for the needs of PSUD/S patients, and to integrate TAO into the COPAD program (COPAD+TAO); 2) to enroll new PSUD/S patients in this enhanced program via random assignment, and to compare outcome between COPAD and COPAD+TAO across 5 assessment domains: treatment retention, psychoactive substance use severity, psychiatric severity, rehospitalization and target complaints; 3) to collect data on longitudinal clinical status and service use on PSUD/S patients, both those retained in the study and drop-outs, through the use of patient tracking, community outreach, and serial evaluations by trained raters; 4) to develop a useful clinical model for treatment of persons with alcohol and/or psychoactive substance abuse disorders and severe mental illness, a model which can be adopted by other general outpatient clinics. This hospital outpatient project will treat predominantly unemployed Black and Hispanic patients who have concurrent diagnoses of Psychoactive Substance Use Disorder (PSUD) and Schizophrenia. If integrated treatment with assertive outreach is more effective than integrated treatment alone, then decreased abuse of drugs and alcohol, and improved psychosocial functioning can be expected over the study period as demonstrated by clinical and evaluation team ratings


Reinforcing Effects of Benzodiazepines in Anxiety

Roache, John; University of Texas Health Science Center

This project will utilize standard behavioral-pharmacologic methods of double blind drug/placebo preference for the study of alprazolam self-medication behavior in anxious outpatients who, because of their psychopathology, are presumed to be at risk for benzodiazepine dependence. All patients will have generalized anxiety but will have no history of substance abuse or dependence. Patients will be allowed to use medication "as needed" and self-administration behaviors will be monitored through the use of automated recording devices. Following initial exposures to color-coded placebo and alprazolam capsules, subjects will be able to choose, under double-blind conditions, which capsules they prefer. The basic hypothesis of this project is that the anxiolytic efficacy of alprazolam will reinforce self-medication behavior in anxious patients but that medication use generally will be therapeutically appropriate and will correspond with anxiety symptom relief. Two experiments will employ patients who have little or no history of prescription anxiolytic use. These studies will: 1) demonstrate reinforcing effects of alprazolam in generally anxious patients with or without panic disorder; 2) determine the effect of patient drug use history on prescription drug use; and 3) determine the ability of cognitive behavior therapy to reduce anxiety symptoms and minimize drug use in anxiety disorders. Both experiments will assess the ability of personality type and patient attitude towards medication use to predict observed drug self-administration behaviors. This research is consistent with NIDA's goals to examine the basic mechanisms of drug reinforcement and the risk factors making one vulnerable to prescription drug dependence. There are three factors of vulnerability being experimentally examined. These are: 1) patient history of other drug use; 2) personality type and attitudes towards drug use; and 3) the effects of untreated anxiety psychopathology to promote self-medication. Furthermore, a significant accomplishment of this research will be the development of outpatient procedures for the study of prescription drug self-administration and reinforcement in therapeutic populations. The results will address fundamental questions regarding the self-medication motivation and its role in the etiology of prescription drug dependence. Furthermore, these studies may experimentally identify patient variables which can predict patterns of medication use placing patients at risk for benzodiazepine dependence. Finally, the research will determine the ability of cognitive behavior therapy to reduce self-medication drug use behaviors and thereby minimize the risks of benzodiazepine dependence.


Developing Family Therapy for BPD Drug Abusing Youths

Santisteban, Daniel; University of Miami

This project will conduct a Stage 1 treatment development study targeting a subtype of drug abusing adolescent, Borderline Personality Disorders (BPD), that have proved to be particularly difficult to treat. The intervention, Borderline Adolescent Family Therapy (BAFT) integrates two successful traditions in intervention research: Structural Family Therapy for drug abusing adolescents with individual skills building components derived from the work of Marsha Linehan with Borderlines. The study is divided into two phases. Phase I is the BAFT development phase including: developing a "working" BAFT manual integrating individual and family components based on archived videotapes; conducting BAFT with three cases to determine ways of enhancing feasibility and acceptability of the modality, and enhancing the focus of BAFT interventions on mechanisms of change specific to families of BPD drug abusing adolescents; and, developing a refined BAFT manual, a manual for therapist selection and training, and a measure of adherence. Phase II consists of a randomized pilot study of 24 cases using a control condition comprised of referrals to community agencies. Analyses are intended to provide information for determining effect sizes for the analyses that would be required in a Stage II efficacy trial, viz., MANOVAs on outcomes (drug abuse, borderline behaviors, conduct problems, and markers of individuals skills development); MANOVAs on postulated mechanisms of actions (family patterns of interactions, negativity/positivity, and therapeutic alliances). Moreover, analyses of clinical significance will be used to identify subgroups for whom the intervention works best, and growth curve analyses will be used to compare the course of change in mechanisms of action between successful and unsuccessful cases.


Enhanced Referral and Social Support in Detoxified Women

Schilling, Robert; Columbia University

Focussing exclusively on women, this five year investigation will test the efficacy of strategies to increase the possibility of a range of post-detoxification outcomes, including treatment entry, self-help participation, and abstinence. The study will develop and test the feasibility and effectiveness of a referral enhancement package comprised of role induction and social support elements. The investigation will also expand understanding of the critical intersection between detoxification and aftercare. Conducted in a hospital in the South Bronx and in the community, the study will include three phases: 1 ) Development - including semi-structured interviews and focus groups with detox patients, staff, and network members; discussions with staff from treatment programs; and a pilot study with referral enhancement and control participants; 2) Outcome study - including assignment of a total of 600 subjects to two study arms; and 3) Data analysis, dissemination, and feedback to and from service providers. In the full scale study, a cohort of new patients entering the unit over a two week period will be assigned to an experimental condition - including group sessions and community sessions involving a therapist, social network member, and the detoxified patient. After the quota is filled, and for the next week, entering patients will not be in the study. Then, for the subsequent two weeks, the next cohort of patients enter the study as controls, who receive the same amount of group and individual intervention, but with differing content. The cycle is repeated over three years, with each condition separated by a "wash-out" period. Subjects will be measured at baseline, briefly upon exit, and at 4, 12 and 40 weeks post-discharge. The study will employ intervention, measurement, and follow-up protocols that builds upon existing theory and research, but which also have immediate relevance to the providers of treatment services. The research will be led by scientists from Columbia University, and will be conducted collaboratively with investigators and staff from St. Barnabas Hospital.


Combining Behavioral Treatments with Agonist Maintenance

Schottenfeld, Richard; Yale University

This project compares daily agonist maintenance on either Buprenorphine 12 mg SL or Methadone 65 mg PO when combined with a manual guided treatment emphasizing either a community reinforcement approach (CRA) alone or CRA plus contingency management (CM) for the treatment of concurrent opioid and cocaine dependence. While there is a compelling need to develop buprenorphine as an alternative to methadone for agonist maintenance treatment of opioid dependence, neither agent is particularly effective for treating concurrent cocaine dependence. CRA combined with CM has shown great promise as treatment for cocaine dependence without concurrent opioid dependence, and this group is interested in replicating and extending the generalizability of this approach to an inner city setting with patients dependent on both opioids and cocaine treated in an agonist maintenance program. The primary aims in this 26 week clinical trial and six month follow-up are 1) to evaluate whether CRA with CM is more effective overall than CRA without CM in reducing illicit opioid and cocaine use; and 2) to compare the efficacy of maintenance on buprenorphine to methadone, when maintenance is combined with CRA with or without CM. Subjects with concurrent opioid and cocaine dependence (N= 168) will be randomly assigned to treatment condition, using an urn randomization technique to assure balanced cells with regard to important baseline characteristics. Medications will be administered in a double blind, double dummy design. Behavioral treatments will be administered by experienced clinicians who will be systematically trained and supervised throughout the study. Primary outcome measures include reduction in opioid and cocaine use, as assessed by three times per week urine toxicology testing during the 26-week trial. Additional outcome measures include retention in treatment and self-report measures of reductions in drug use and improvements in psychosocial functioning, based on weekly self-report and repeated monthly ASI measures. Data analysis will be based on an intention to treat sample. follow-up assessments at 3 and 6 months after completion of the treatment protocol will allow evaluation of the durability of treatment effects.


Behavioral Treatments for Cocaine Dependent Women

Schottenfeld, Richard; Yale University

This project involves a dismantling strategy to evaluate the multi-faceted Community Reinforcement Approach (CRA) and Contingency Management (CM), promising behavioral treatments for cocaine dependence, in an inner city population of cocaine-dependent pregnant and postpartum women. In the 2x2 factorial design, CRA will be compared to a standard, less intensive treatment, drug counseling (DC), and both CRA and DC will be combined with either contingency management (CM), utilizing vouchers worth a monetary value as a reward for abstinence, or non-contingent vouchers yoked in value to vouchers provided in CM (voucher control, VC). Cocaine-dependent women (N = 180) who either are pregnant or have given birth to a child during the past three months will be randomly assigned to one of four treatment conditions: CRA+CM, CRA+VC, DC+CM, or DC+VC. Treatment will be provided for 24 weeks by trained and experienced therapists. CRA will be provided in twice weekly one hour individual sessions, and DC will be provided in a weekly 50 minute individual session and a brief 10 minute follow-up session. All treatments are manual-guided and will be carefully monitored to insure adherence to the manuals and competence of the therapists. Major outcome measures, assessed during the clinical trial and at three and six months following completion of the trial, include reductions in cocaine use, reduced HIV risk behavior, and improved knowledge of parenting and maternal- child interactions.


Treatment of Heroin Dependent Poly Drug Abusers

Schuster, Charles; Wayne State University

This study was designed to develop a more effective treatment program for heroin-dependent poly-drug abusers. This group aims to determine whether Voucher-Based Reinforcement Therapy (VBRT) enhances outcome when combined with a pharmacotherapy/psychosocial treatment program. Previous studies demonstrated that both the pharmacotherapy (buprenorphine) and VBRT are moderately effective for decreasing heroin abuse when used independently. VBRT involves contingent reinforcement for drug-free urines; it is designed to reinforce continuous abstinence and the development of a drug-free lifestyle. Previous studies have used VBRT to target a specific drug; however, the approach can be easily extended to target use of several illicit drugs concurrently, as is in this study. In contrast, buprenorphine alone is often not effective in helping patients achieve abstinence from the other drugs often abused by heroin dependent individuals since buprenorphine's effects are pharmacologically specific. The aim of this project is to determine whether VBRT can enhance a standard buprenorphine program's effectiveness in achieving abstinence from several drugs. Other specific aims include evaluation of (a) the relative efficacy of a reduced-value VBRT program; (b) a less costly urine testing regimen; and (c) the role of gender, race, and psychiatric comorbidity, including Antisocial Personality Disorder, in treatment outcome. Heroin dependent polydrug abusers will receive buprenorphine in the context of our standard psychosocial clinic program (29 Weeks). They will be inducted onto buprenorphine during Weeks 1-2 and maintained on a fixed dose for Weeks 3 through 25. At week 6 all participants who continue to show evidence of illicit drug use will be randomly assigned to one of three treatment groups for a twelve week VBRT phase (Weeks 6-17). The three treatment groups are standard VBRT, a VBRT condition in which voucher values are reduced, and a yoked control condition. Yoked control participants are linked to an active VBRT participant and receive vouchers of the same value and frequency as that individual, but independent of their urinalysis results. After the VBRT intervention phase, participants will be maintained on buprenorphine with weekly individual counseling and medical monitoring for 8 more weeks (Weeks 18-25), followed by a 4week phase of gradual withdrawal from buprenorphine (Weeks 26-29). All participants will be asked to return to the clinic for a 12-month follow-up visit.


Contingency Management: Tobacco Smoking in Opiate Addicts

Shoptaw, Steven; Los Angeles Addiction Treatment Research Center

This project uses a 2 x 2 factorial design to compare efficacy of two behavioral methods, relapse prevention (RP) and contingency management (CM), for reducing tobacco smoking in methadone treated opiate addicts. All subjects will receive standard transdermal nicotine patch treatment to ameliorate nicotine withdrawal symptoms, which should make comparisons between conditions meaningful. The project also evaluates associations between cigarette smoking and illicit drug use at baseline, during treatment and at follow-up. A total of 220 subjects seeking smoking cessation treatment will be randomly assigned to one of four experimental treatment groups: (1) RP only; (2) CM only; (3) combined RP + CM; and (4) neither RP nor CM - a control condition that will receive nicotine patch only. The battery of assessments to measure various dimensions of smoking include the following: Demographic information; drug use history (ASI); psychiatric diagnosis (SCID); measurement of stage of readiness for change (URICA); biological markers of smoking (CO breath levels, serum thiocyanate); physical measures of drug use (urine toxicology) self report of smoking and drug use (Fagerstrom, TLFB); mood and physical symptoms (SCL-90-R); treatment compliance (TSR; RP Survey); and staff clinical impression (CGI). Behavioral interventions are manualized and an audiotape procedure will be used to monitor and enhance protocol compliance.

The project provides a definitive controlled trial of the comparative efficacy for integrating behavioral therapies with a pharmacological treatment for smoking cessation in this high-risk population. Project findings will have relevance to applied settings and to theoretical understanding of interrelationships between tobacco smoking and other drug use.


A Therapeutic Workplace for Drug Abusers

Silverman, Kenneth; Johns Hopkins University

Economic and social conditions are recognized as important determinants of drug abuse, leading some observers to suggest that a primary focus of drug abuse treatment should be to alter those basic living conditions that are at the roots of the problem. Unemployment is one of those conditions that has received considerable attention. Indeed, drug use is associated with unemployment in the general population, it is common among drug abusers in treatment, and it is associated with poor treatment outcomes.

Supported work programs represent a promising approach in the treatment of severe employment problems among drug abusers since they provide job training, work experience, and income. But these programs have an extraordinary, yet simple potential use in the treatment of drug abuse that thus far has not been tapped, and herein lies the crux of this project: The salaries that supported work participants earn for work can also be used to reinforce drug abstinence. This group aims to develop and evaluate a model therapeutic workplace for drug abusers that utilizes this untapped potential of supported workplaces. The therapeutic workplace is designed to integrate the therapeutic effects of abstinence reinforcement contingencies of proven efficacy into a model supported work environment. The target population will be new mothers who are patients in a model treatment program for pregnant drug-abusing women, a population sorely in need of effective interventions to control their drug use and associated risk of acquiring HIV infection and AIDS, as well as interventions to improve their employment status.

A pilot phase and one controlled study are planned over a three-year period. The pilot phase will be conducted to refine the therapeutic workplace procedures including refinement of the teaching curriculum training of staff, refining the scheduling and payment parameters, and integrating of research and training activities. The main study will examine the effects of voucher reinforcement on abstinence and workplace attendance using a balanced factorial design in which incentives are targeted on attendance, abstinence, both or neither for different subject groups. The hypothesis is that best overall outcomes (on productivity and drug use) will be obtained when both desired behaviors (abstinence and attendance) are targeted. This study will directly test the therapeutic benefits of the novel idea using appropriate control and comparison conditions.

Overall, these studies will allow for the development and rigorous evaluation of a novel approach to the treatment of drug abuse the therapeutic workplace, in a population of drug abusing new mothers who desperately need effective interventions to control their drug use and to improve their employment status.


Outpatient Treatment for IV Drug Abusers

Stitzer, Maxine; Johns Hopkins University

Outpatient drug-free (non-methadone) treatment is the most widely utilized of available drug abuse treatment modalities. Yet it has received disproportionately little attention in research and development efforts. One group particularly in need of outpatient care are recently detoxified i.v. drug abusers. These individuals have already utilized significant treatment resources during their inpatient stay but remain at risk for HIV infection if they return immediately to drug use upon discharge. Prognosis would be improved by enrollment in continuing care. Yet rates of initiating outpatient treatment after being referred from a detox program are surprisingly low and retention in outpatient treatment is extremely poor. The purpose of this services research project is to investigate 1) methods for transitioning IV drug abusers of heroin or heroin and cocaine from detoxification to outpatient aftercare treatment services; 2) methods for retaining these patients in aftercare treatment once they make a program contact and 3) methods for preventing relapse to drug use after the brief inpatient period of abstinence. Study 1 will document naturalistic outcomes over 6 months in a cohort (N = 150) of IV drug users discharged from a 3-day medically supervised detoxification program to determine the extent and duration of their post detox treatment enrollment as well as drug use, social adjustment and HIV risk exposure outcomes. Study 2 will determine the impact of four treatment transition interventions (commitment contracting, contingency contracting, escorted referral and usual care referral) on patients' post-detox contact with and subsequent retention in outpatient drug-free treatment. Study 3 will evaluate separate and combined effects on treatment retention of two practical interventions-transportation service and incentive payment designed to promote retention in outpatient treatment, which is typically very poor. Finally, Study 4 will a) evaluate effects on treatment retention and drug use of abstinence incentive procedures previously shown effective for outpatient treatment of cocaine abusers, b) evaluate effects of intensive behavioral counseling modeled on the Community Reinforcement Approach previously shown effective for outpatient treatment of alcoholics and cocaine abusers, and c) determine the extent to which behavioral counseling enhances the benefits of abstinence incentive procedures designed to directly influence drug abusers toward achieving desired outcome goals. Overall, this grant project will provide valuable new information about the effectiveness of methods to attract and retain IV drug abusers in outpatient drug-free treatment and to achieve relapse prevention goals. The treatment outcome data obtained from patients making the transition from medically supervised detoxification treatment to outpatient aftercare, will have broader application for improving any outpatient drug-free treatment service. The data generated will have implications for policy debates about the most effective way to spend limited resources in order to produce the best results from outpatient drug abuse treatment services.


Behavioral Methods for Cigarette Smoking Cessation

Stitzer, Maxine; Johns Hopkins University

Resumption of smoking within 3 months is the most common sequela to a cessation attempt. The relapse process, which begins with a single smoking episode (i.e., a slip or lapse), almost invariably leads to full relapse at some subsequent time point, usually sooner than later. Psychopharmacologically, this sequence of events may be explained by the stimulus priming effect, in which drug-seeking behaviors are reinstated following re exposure to the drug during a period of abstinence. This group proposes a series of five interrelated studies to be conducted with both experimental and clinical populations that will systematically examine the effects of experimentally scheduled smoking lapses and their modulation by nicotine replacement (via patch). For all studies, the experimental model will be to simulate a smoking lapse under controlled laboratory conditions. In this way, they will be able to manipulate and measure the lapse dose (dose-effects) as well as document the effects of varying lapse doses on the subsequent relapse behaviors. Two specific models of smoking relapse will be explored; one involves a laboratory choice procedure in which subjects choose between smoking versus abstinence following lapse exposures. In other studies, several prospective natural environment measures of return to smoking over post-exposure days will be measured. Overall, these prospective studies should provide valuable information concerning the biobehavioral processes underlying smoking relapse with specific empirical support for the priming effect and its relationship to smoking relapse. Findings should provide new information about the time course of subjective and physiological effects important in the lapse-to-relapse process. Finally, they aim to provide clinically valuable information concerning the potential relapse prevention utility of nicotine replacement via modulation of stimulus exposure effects.


Structural Ecosystems Tx with Drug Using Minority Youth

Szapoznik, Jose; University of Miami

The primary aims of the study are to: 1) investigate the efficacy of Structural Ecosystems Therapy (SET) in reducing adolescent drug use and conduct problems, and 2) examine it's theoretical mechanisms of action. SET is a culturally sensitive comprehensive ecosystemic intervention that systematically targets maladaptive patterns of interaction at three levels of the adolescent's social ecology: microsystem (family, peers, school, and justice system), mesosystem (family-peer, family-school, and family-justice system), and exosystem (parental support system). It is hypothesized that improvements in functioning at these three levels will lead to: 1) reductions in symptomatic behaviors of a) drug use, and b) conduct, delinquent, and antisocial behaviors; and 2) improvements in psychosocial functioning.

An experimental design is achieved by randomly assigning 312 (156 African-American, 156 Hispanic) drug using, behavior problem adolescents to one of three treatment conditions: SET, Structural family therapy (FAM), and community control (CC). FAM represents one standard of care in the treatment of drug using, behavior problem adolescents, and CC is intended to replicate the typical range of services currently provided in our community. Three rigorous procedures are designed to ensure fidelity to conditions. Comprehensive assessments of adolescent drug use, conduct problems, and functioning at each of the three ecosystemic levels are conducted at baseline, and 6, 12, and 18 months post-baseline.

Analyses investigate the intervention's direct effects on behavioral outcomes (drug use, conduct problems, and psychosocial functioning), and hypothesized mediators (micro-, meso-, and exosystemic functioning), as well as the contribution of each mediator to outcome. Analyses include RMANOVA, structural equations modeling, and Hierarchical Linear Modeling. Additional analyses explore the moderating effects of race/ethnicity, culture, treatment adherence, and treatment dosage.


Family Systems Engagement with Drug Abusing Mothers

Szapocznik, Jose; University of Miami

This study investigates the efficacy of Strategic Structural Family Systems Engagement in bringing about entry and retention in treatment of African American drug abusing mothers. The study builds on a long history of research by the P.I. on developing family oriented interventions with minority drug abusers, and particularly on highly successful research on developing and testing the effectiveness of family- oriented strategies for improving engagement rates for drug abusers. The study will test the efficacy of the experimental intervention by randomizing 198 African American women to one of three conditions: Strategic Structural Family Systems Engagement, a Client-Centered, Non-Directive Attention Control Condition to control for non-specific effects, and an Engagement as Usual Control Condition that maximizes ecological validity. Women in all conditions receive the Engagement as Usual interventions that is the standard of care provided by the Florida Department of Health and Rehabilitative Services. Women in the study will have given birth to infants who tests positive for cocaine on a urine toxicology screen. In addition to manuals for the Experimental and Attention Control conditions, four different strategies are proposed for ensuring treatment fidelity including regular supervision, condition specific expert supervision, and objective blind ratings of interventions from therapists' notes and audiotaped sessions. The impact of individual (i.e., distress, stages of change) and life context (i.e., social support, stressors) factors outside the intervention on treatment entry are investigated. Theoretical mechanisms that may mediate the efficacy of the experimental condition are explored by coding family process occurring during family interventions: supportive interactions (empathic, positive affect, positive coalition), structuring interactions (request for action, directing flow) and defensive interactions (blaming, negative coalition, attack). Analyses include Del, MANOVAs, multiple logistic regressions, structural equations modeling, and survival analyses.


Imipramine-Relapse Prevention in Depressed Methadone Patients

Tross, Susan; St. Luke's Roosevelt Hospital

This study will determine the efficacy of Relapse Prevention (RP) plus imipramine vs. supportive counseling plus imipramine vs. imipramine alone in reducing cocaine use and HIV/AIDS risk behaviors and depressive symptoms in depressed methadone patients who use cocaine. Relapse prevention is a widely used cognitive-behavioral skills training approach to the problem of initiating and maintaining drug use abstinence. Imipramine has been shown to have strong antidepressant effects and significant, but qualified, effects on self-reported drug use among depressed cocaine-using methadone patients. Among this substantial subgroup of patients, there are no studies of the efficacy of combination pharmacotherapeutic and psychotherapeutic approaches to the problem of cocaine use. This study will examine the question of whether adding relapse prevention group to imipramine is more effective than imipramine alone in reducing cocaine use among 252 inner-city depressed methadone patients who use cocaine. It will have the methodological advantages of: (1) including a non-specific psychological intervention comparison condition (i.e. support group); and (2) targeting a sample with rigorously diagnosed DSM-IV depressive disorders. It will have the important clinical advantage of using a manual-driven relapse prevention protocol - that will draw from two programs with demonstrated efficacy. This study will also assess the impact of potential predictors on intervention effects on cocaine use, especially severity of cocaine use and severity of depression. It will also assess the impact of potential mediators, representing acquisition of intervention components, on intervention effects on cocaine use, especially: level of relapse prevention skill and perceived self-efficacy to use these skills. Patients will be assessed on repeated measures of cocaine use and depression at: baseline, end of psychological intervention (at 3 months), end of imipramine maintenance (at 6 months) and 3- month post-intervention follow-up (at 9 months).


Drug Abuse Treatments for Adolescents

Waldron, Holly; University of New Mexico, Albuquerque

Drug abuse among adolescents is a pressing health concern with serious consequences for individual youth and for society as a whole. Although the magnitude of the problem has stimulated a dramatic increase in research attention in recent years, the field of adolescent substance abuse has been characterized by an absence of controlled clinical trials of drug abuse intervention programs, and few effective, replicable, and enduring treatment strategies have been identified. Self-regulation models, which aim to enable adolescents to identify appropriate behavioral goals and use self-regulation skills such as stimulus control and contingency reinforcement to prompt desirable behaviors, have been used successfully for drug abuse prevention, but research on treatment programs for adolescents abusers has been rare. Similarly, family treatments increasingly have been advocated. Many family therapists argue that drug abuse develops and is maintained in the context of maladaptive family relationships and that correcting faulty family interaction patterns will, in turn, reduce adolescents' involvement with drugs. Despite considerable enthusiasm which has been generated for these approaches, however, few studies have systematically investigated the effectiveness of family therapy with substance abusers. This clinical trial for adolescent drug abusers will examine treatment outcomes for two contrasting intervention approaches, individual self-regulation skills training and family therapy. The effectiveness of these interventions will be compared with an education-based group intervention. The self-regulation training and family therapy approaches will also be offered in combination in a fourth condition, to evaluate the additive treatment effects for adolescents and their families. Together, an evaluation of outcomes across the four conditions will provide a clearer understanding of which approaches to treatment have greatest benefit at the level of the individual drug abuser, the abusers' parents and siblings, and the family system functioning. The project will also allow for an examination of treatment matching variables to address whether some adolescents respond better to one type of treatment than another. Outcome research, however, is often limited by insufficient attention to therapy process variables related to successful outcomes. To address this issue, this trial will also examine client and therapist characteristics and treatment operations which may influence treatment outcome.


Therapy For Drug Abusers With Psychiatric Comorbidity

Ziedonis, Douglas; Yale University

Cocaine abuse is common among schizophrenic patients in mental health treatment settings and results in poor clinical outcomes including increased hospitalizations, suicide attempts, emergency room visits, periods of homelessness, and episodes of violent behavior. Individuals with this comorbidity respond poorly to traditional drug abuse and psychiatric treatments. There exists a great clinical and research need to develop innovative and well-defined behavioral therapies for this population which address both the psychiatric and substance abuse problems. This project will develop and pilot test the Dual Diagnosis Relapse Prevention (DDRP) psychotherapy approach in the treatment of schizophrenic cocaine abusers. This already promising cognitive-behavioral approach integrates and modifies traditional substance abuse relapse prevention and psychiatric social skills training (including psychiatric symptom and medication management).

The specific aims of this project are to:

1. Develop a DDRP Therapist Training Manual & Patient Workbook; 2. Develop Competence & Adherence Rating scales; 3. Develop and conduct a Didactic Training Program; and 4. Perform a Pilot Study of the DDRP Treatment, Training, and Rating Scales.

At the end of this three year Stage One behavioral psychotherapy study, they anticipate to have the methods and pilot data to support a Stage Two efficacy trial.

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