Research Findings - CTN-Related Research
Correspondence of Motivational Enhancement Treatment Integrity Ratings Among Therapists, Supervisors, and Observers
This study examined the correspondence of treatment integrity ratings (adherence and competence) among community program therapists, supervisors, and observers for therapists who used motivational enhancement therapy (MET) within a National Institute on Drug Abuse Clinical Trials Network protocol. The results suggested there was reasonable agreement between the three groups of raters about the presence or absence of several fundamental MET strategies. Moreover, relative to observers, therapists and supervisors were more positive in their evaluations of the therapists' MET adherence and competence. These findings underscore the need for objective monitoring of therapists' performance when using empirically supported treatments and for adequately training therapists and supervisors to evaluate their treatment implementation in community programs. These findings are also consistent with observations that different perspectives on the therapeutic process are not interchangeable. Martino S, Ball S, Nich C, Frankforter TL, Carroll KM. Psychother Res. 2009 Mar;19(2):181-193.
Quality Assurance of Research Protocols Conducted in the Community: The National Institute on Drug Abuse Clinical Trials Network Experience
Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies, with a total of 6,560 participants randomized across the sites. During this time, 1,937 QA site visits were reported across the three tiers of monitoring. Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. Cost of monitoring depended on the location of the sites and the salaries of the staff involved. One limitation with this study was that QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. The lessons learned from the CTN's experience included the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. Rosa C, Campbell A, Kleppinger C, Sampson R, Tyson C, Mamay-Gentilin S. Clin Trials. 2009 Apr;6(2):151-161.
Brief Strategic Family Therapy for Adolescent Drug Abusers: A Multi-Site Effectiveness Study
This design paper describes the following aspects of the study: specific aims, research design and study organization, assessment of primary and secondary outcomes, study treatments, data analysis plan, and data monitoring and safety reporting. Within the National Institute on Drug Abuse's (NIDA's) Clinical Trials Network, BSFT (Brief Strategic Family Therapy) is being compared to treatment as usual (TAU) in a multisite, prospective randomized clinical trial for drug using adolescents and their families in outpatient settings. The effectiveness of BSFT is being compared to TAU in reducing adolescent drug use, conduct problems, and sexually risky behaviors as well as in improving family functioning and adolescent prosocial behaviors.
Robbins MS, Szapocznik J, Horigian VE, Feaster DJ, Puccinelli M, Jacobs P, Burlew K, Werstlein R, Bachrach K, Brigham G. Contemp Clin Trials. 2009 May;30(3):269-278. E-pub 2009 Jan 17.
An Item Response Theory Modeling of Alcohol and Marijuana Dependences: A National Drug Abuse Treatment Clinical Trials Network Study
The aim of this study was to examine psychometric properties of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnostics criteria for alcohol and marijuana dependences among 462 alcohol users and 311 marijuana users enrolled in two multisite trials of the National Drug Abuse Treatment Clinical Trials Network. Diagnostic questions were assessed by the DSM-IV checklist. Data were analyzed by the item response theory and the multiple indicators-multiple causes method procedures. Criterion symptoms of alcohol and marijuana dependences exhibited a high level of internal consistency. All individual symptoms showed good discrimination in distinguishing alcohol or marijuana users between high and low severity levels of the continuum. In both groups, "withdrawal" appeared to measure the most severe symptom of the dependence continuum. There was little evidence of measurement nonequivalence in assessing symptoms of dependence by gender, age, race/ethnicity, and educational level. These findings highlight the clinical utility of the DSM-IV checklist in assessing alcohol- and marijuana dependence syndromes among treatment-seeking substance users. Wu LT, Pan JJ, Blazer DG, Tai B, Stitzer ML, Brooner RK, Woody GE, Patkar AA, Blaine JD. J Stud Alcohol Drugs. 2009 May;70(3): 414-425.
The Impact of Trauma-Focused Group Therapy upon HIV Sexual Risk Behaviors in the NIDA Clinical Trials Network "Women and Trauma" Multi-Site Study
Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treat-ment at six community-based drug treatment programs participating in NIDA's Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women's health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk. Hien DA, Campbell AN, Killeen T, Hu MC, Hansen C, Jiang H, et al., AIDS Behav. 2009 May 19.[E-pub ahead of print].
Heterogeneity of Stimulant Dependence: A National Drug Abuse Treatment Clinical Trials Network Study
The authors investigated the presence of DSM-IV subtyping for dependence on cocaine and amphetamines (with versus without physical dependence) among outpatient stimulant users enrolled in a multisite study of the Clinical Trials Network (CTN). Three mutually exclusive groups were identified: primary cocaine users (n = 287), primary amphetamine users (n = 99), and dual users (cocaine and amphetamines; n = 29). Distinct subtypes were examined with latent class and logistic regression procedures. Cocaine users were distinct from amphetamine users in age and race/ethnicity. There were four distinct classes of primary cocaine users: non-dependence (15%), compulsive use (14%), tolerance and compulsive use (15%), and physiological dependence (tolerance, withdrawal, and compulsive use; 56%). Three distinct classes of primary amphetamine users were identified: non-dependence (11%), intermediate physiological dependence (31%), and physiological dependence (58%). Regardless of stimulants used, most female users were in the most severe or the physiological dependence group. These results lend support for subtyping dependence in the emerging DSM-V. Wu LT, Blazer DG, Patkar AA, Stitzer ML, Wakim PG, Brooner RK. Am J Addict. 2009 May-Jun;18(3):206-218.
Facilitating Outpatient Treatment Entry Following Detoxification for Injection Drug Use: A Multisite Test of Three Interventions
A multisite, randomized trial within the National Drug Abuse Treatment Clinical Trials Network (CTN) was conducted to test 3 interventions to enhance treatment initiation following detoxification: (a) a single session, therapeutic alliance intervention (TA) added to usual treatment; (b) a 2-session, counseling and education, HIV/HCV risk reduction intervention (C&E), added to usual treatment; and (c) treatment as usual (TAU) only. Injection drug users (n=632) enrolled in residential detoxification at 8 community treatment programs were randomized to 1 of the 3 study conditions. TA participants reported entering outpatient treatment sooner and in greater numbers than TAU participants. Reported treatment entry for C&E fell between TA and TAU with no significant differences between C&E and the other conditions. There were no differences among the interventions in retention, as measured by weeks of outpatient treatment for all participants who reported treatment entry. Alliance building interventions appear to be effective in facilitating transfer from detoxification to outpatient treatment, but additional treatment engagement interventions may be necessary to improve retention. Copyright (c) 2009 APA, all rights reserved. Campbell BK, Fuller BE, Lee ES, Tillotson C, Woelfel T, Jenkins L, Robinson J, Booth RE, McCarty D. Psychol Addict Behav. 2009 Jun;23(2):260-270.
Disparities in Health Services for HIV/AIDS, Hepatitis C Virus, and Sexually Transmitted Infections: Role of Substance Abuse Treatment Programs
The prominence of healthcare disparities in public health discussions has spurred interest in the identification of those disparities, studying their causes, and pursuing possible remedies. Women and minority populations experience disparities in health and healthcare related to many factors including access to services. These disparities extend to issues around addiction and addiction-related infections. The findings of this report suggest that there appear to be some alignment between services offered and these health and healthcare disparities. In a cross-sectional, descriptive design, treatment program administrators across the United States within the National Drug Abuse Treatment Clinical Trials Network (protocol CTN-0012) provided information on program characteristics, the availability of infection-related services (4 medical services and 3 nonmedical services for HIV, hepatitis C virus, and sexually transmitted infections), and barriers to providing infection-related services. Of 319 programs surveyed, 269 participated. Of these, 80% provided addiction services for special populations. Programs providing addiction services designed for at least one special population were more likely to provide infection-related health services, especially HIV-related education (94% vs. 85%) and patient counseling (76% vs. 60%) and were more likely to include outpatient addiction services (86% vs. 57%) and outreach and support services (92% vs. 70%). Primary barriers to providing infection-related services included government funding, private health insurance, and patient acceptance. But despite those barriers, programs with addiction services designed for women and nonwhite ethnic/racial populations provide infection-related health services more often than programs without these specially designed addiction services. The findings of this study strongly suggest that the tailoring of substance abuse treatment is an important public health strategy in addressing both the control of these infections and perhaps in reducing some of the disparities associated with them. Brown LS Jr, Kritz SA, Muhammad A, Bini EJ, Goldsmith RJ, Robinson J, Alderson D, Hasin DS, Rotrosen J. J Addict Med. 2009;3(2):95-102.
Evaluating Motivational Enhancement Therapy Adherence and Competence Among Spanish-Speaking Therapists
Despite the fact that the number of Hispanic individuals in need of treatment for substance use problems is increasing internationally, no studies have investigated the extent to which therapists can provide empirically supported treatments to Spanish-speaking clients with adequate fidelity. Twenty-three bilingual Hispanic therapists from five community outpatient treatment programs in the United States were randomly assigned to deliver either three sessions of motivational enhancement therapy (MET) or an equivalent number of drug counseling-as-usual (CAU) sessions in Spanish to 405 Spanish-speaking clients randomly assigned to these conditions. Independent ratings of 325 sessions indicated the adherence/competence rating system had good to excellent interrater reliability and indicated strong support for an a priori defined fundamental MET skill factor. Support for an advanced MET skill factor was relatively weaker. The rating scale indicated significant differences in therapists' MET adherence and competence across conditions. These findings indicate that the rating system has promise for assessing the performance of therapists who deliver MET in Spanish and suggest that bilingual Spanish-speaking therapists from the community can be trained to implement MET with adequate fidelity and skill using an intensive multisite training and supervision model. Santa Ana EJ, Carroll KM, A–ez L, Paris M Jr, Ball SA, Nich C, Frankforter TL, Suarez-Morales L, Szapocznik J, Martino S. Drug Alc Depend. 2009 Jul 1;103(1-2):44-51. E-pub 2009 Apr 24.
The Construct and Measurement Equivalence of Cocaine and Opioid Dependences: A National Drug Abuse Treatment Clinical Trials Network (CTN) Study
Although DSM-IV criteria are widely used in making diagnoses of substance use disorders, gaps exist regarding diagnosis classification, use of dependence criteria, and effects of measurement bias on diagnosis assessment. Researchers examined the construct and measurement equivalence of diagnostic criteria for cocaine and opioid dependences, including whether each criterion maps onto the dependence construct, how well each criterion performs, how much information each contributes to a diagnosis, and whether symptom-endorsing is equivalent between demographic groups. Item response theory (IRT) and multiple indicators-multiple causes (MIMIC) modeling were performed on a sample of stimulant-using methadone maintenance patients enrolled in a multisite study of the National Drug Abuse Treatment Clinical Trials Network (CTN) (N=383). Participants were recruited from six community-based methadone maintenance treatment programs associated with the CTN and major U.S. providers. Cocaine and opioid dependences were assessed by DSM-IV Checklist. IRT modeling showed that symptoms of cocaine and opioid dependences, respectively, were arrayed along a continuum of severity. All symptoms had moderate to high discrimination in distinguishing drug users between severity levels. "Withdrawal" identified the most severe symptom of the cocaine dependence continuum. MIMIC modeling revealed some support for measurement equivalence. Study results suggest that self-reported symptoms of cocaine and opioid dependences and their underlying constructs can be measured appropriately among treatment-seeking polysubstance users. Wu LT, Pan JJ, Blazer DG, Tai B, Brooner RK, Stitzer ML, Patkar AA, Blaine JD. Drug Alcohol Depend. 2009 Aug 1;103(3):114-123. E-pub 2009 May 6.
Multisite Randomized Trial of Behavioral Interventions for Women with Co-occurring PTSD and Substance Use Disorders
The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353 women to receive 12 sessions of Seeking Safety (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment 1 week and 3, 6, and 12 months posttreatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS), the PTSD Symptom Scale-Self Report (PSS-SR), and a substance use inventory (self-reported abstinence and percentage of days of use over 7 days). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively) but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline. Study results do not favor Seeking Safety over WHE as an adjunct to substance use disorder treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions. Hien DA, Wells EA, Jiang H, Suarez-Morales L, Campbell AN, Cohen LR, Miele GM, Killeen T, Brigham GS, Zhang Y, Hansen C, Hodgkins C, Hatch-Maillette M, Brown C, Kulaga A, Kristman-Valente A, Chu M, Sage R, Robinson JA, Liu D, Nunes EV. J Consult Clin Psychol. 2009 Aug;77(4):607-619.