Research Findings - CTN-Related Research
Facilitating Involvement in Twelve-Step Programs
Twelve-step programs represent a readily available resource for individuals with substance use disorders. These programs have demonstrated considerable effectiveness in helping substance abusers achieve and maintain abstinence and improve their overall psychosocial functioning and recovery. Despite these positive benefits associated with increased involvement in twelve-step self-help programs, many substance abusers do not affiliate or do so for only a short period of time before dropping out. Because of this, clinicians and researchers have sought ways to increase involvement in such self-help groups by facilitating meeting attendance and engagement in other twelve-step activities. The present chapter reviews the impact of treatment program orientation and specific interventions designed to facilitate twelve-step program involvement, subsequent meeting attendance, engagement in twelve-step activities, and alcohol and drug use. The findings of studies evaluating these approaches indicate that it is possible to increase twelve-step involvement and that doing so results in reduced substance use. The results suggest that incorporating these evidence-based interventions into standard treatment programs may lead to improved outcomes. Donovan DM, Floyd AS. Facilitating involvement in twelve-step programs. Recent Dev Alcohol. 2008;18:303-20.
Measurement and Data Analysis in Research Addressing Health Disparities in Substance Abuse
This article describes concrete strategies for conducting substance abuse research with ethnic minorities. Two issues associated with valid analysis, measurement and data analysis, are included. Both empirical (e.g., confirmatory factor analysis, item response theory, and regression) and nonempirical (e.g., focus groups, expert panels, pilot studies, and translation equivalence) approaches to improve measures are described. A discussion of the use of norms and cutoff scores derived from a different ethnic group along with the effects of the ethnicity of the interviewer or coder on measurement is included. The section on data analysis describes why the use of race-comparison designs may lead to misleading conclusions. Alternatives to race-comparison analysis including within-group and between-group analyses are described. The shortcomings of combining ethnic groups for analyses are discussed. The article ends with a list of recommendations for research with ethnic minorities. Burlew AK, Feaster D, Brecht ML, Hubbard R. Measurement and data analysis in research addressing health disparities in substance abuse. J Subst Abuse Treat. 2009;36(1):25-43. Epub 2008 Jun 11.
Motivational and Skills Training HIV/Sexually Transmitted Infection Sexual Risk Reduction Groups For Men
The effectiveness of a motivational and skills training HIV/AIDS group intervention designed for men in substance abuse treatment was evaluated. Men in methadone maintenance (n = 288) or outpatient psychosocial treatment (n = 302) completed assessments at baseline, 2 weeks, 3 months, and 6 months postintervention. Participants were randomly assigned to attend either Real Men Are Safe (REMAS; five sessions containing information, motivational exercises, and skills training) or HIV education (HIV-Ed; one session containing HIV prevention information). REMAS participants engaged in significantly fewer unprotected vaginal and anal sexual intercourse occasions (USO) during the 90 days prior to the 3- and 6-month follow-ups than HIV-Ed participants. Completing REMAS resulted in an even stronger effect: Completers reduced their number of USO by 21% from baseline to 6-month follow-up. In contrast, HIV-Ed completers increased the number of USO by 2%. A motivational and skills training HIV prevention intervention designed for men was associated with greater sexual risk reduction over standard HIV-Ed. Substance abuse treatment programs can therefore help reduce sexual risk among their clientele by providing a more intensive intervention than what is traditionally provided. Calsyn DA, Hatch-Maillette M, Tross S, Doyle SR, Crits-Christoph P, Song YS, Harrer JM, Lalos G, Berns SB. Motivational and skills training HIV/sexually transmitted infection sexual risk reduction groups for men. J Subst Abuse Treat. 2009; Jan 14. [Epub ahead of print].
Buprenorphine Tapering Schedule and Illicit Opioid Use
The aims of this study were to compare the effects of a short or long taper schedule after buprenorphine stabilization on participant outcomes as measured by opioid-free urine tests at the end of each taper period. This multi-site study sponsored by Clinical Trials Network (CTN, a branch of the US National Institute on Drug Abuse) was conducted from 2003 to 2005 to compare two taper conditions (7 days and 28 days). Data were collected at weekly clinic visits to the end of the taper periods, and at 1-month and 3-month post-taper follow-up visits. The setting included eleven out-patient treatment programs in 10 US cities. The intervention was non-blinded dosing with Suboxone during the 1-month stabilization phase included 3 weeks of flexible dosing as determined appropriate by the study physicians. A fixed dose was required for the final week before beginning the taper phase. Measurements obtained were the percentage of participants in each taper group providing urine samples free of illicit opioids at the end of the taper and at follow-up. At the end of the taper, 44% of the 7-day taper group (n = 255) provided opioid-free urine specimens compared to 30% of the 28-day taper group (n = 261; P = 0.0007). There were no differences at the 1-month and 3-month follow-ups (7-day = 18% and 12%; 28-day = 18% and 13%, 1 month and 3 months, respectively). The authors conclude that for individuals terminating buprenorphine pharmacotherapy for opioid dependence, there appears to be no advantage in prolonging the duration of taper. Ling W, Hillhouse M, Domier C, Doraimani G, Hunter J, Thomas C, Jenkins J, Hasson A, Annon J, Saxon A, Selzer J, Boverman J, Bilangi R. Buprenorphine tapering schedule and illicit opioid use. Addiction. 2009;104(2):256-65.
A Centralized Informatics Infrastructure for the National Institute on Drug Abuse Clinical Trials Network
Clinical trial networks (CTNs) were created to provide a sustaining infrastructure for the conduct of multisite clinical trials. As such, they must withstand changes in membership. Centralization of infrastructure including knowledge management, portfolio management, information management, process automation, work policies, and procedures in clinical research networks facilitates consistency and ultimately research. In 2005, the National Institute on Drug Abuse (NIDA) CTN transitioned from a distributed data management model to a centralized informatics infrastructure to support the network's trial activities and administration. This paper describes the centralized informatics infrastructure and discusses challenges that were encountered to inform others considering such an endeavor. During the migration of a clinical trial network from a decentralized to a centralized data center model, descriptive data were captured and are presented here to assess the impact of centralization. Authors present the framework for the informatics infrastructure and evaluative metrics. The network has decreased the time from last patient-last visit to database lock from an average of 7.6 months to 2.8 months. The average database error rate decreased from 0.8% to 0.2%, with a corresponding decrease in the interquartile range from 0.04%-1.0% before centralization to 0.01-0.27% after centralization. Centralization has provided the CTN with integrated trial status reporting and the first standards-based public data share. A preliminary cost-benefit analysis showed a 50% reduction in data management cost per study participant over the life of a trial. Since a single clinical trial network comprising addiction researchers and community treatment programs was assessed these findings may not be applicable to other research settings. The authors conclude that the identified informatics components provide the information and infrastructure needed for our clinical trial network. Post centralization data management operations are more efficient and less costly, with higher data quality. Pan JJ, Nahm M, Wakim P, Cushing C, Poole L, Tai B, Pieper CF. A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network. Clin Trials. 2009;6(1):67-75.
Understanding Attitudes Toward Use of Medication in Substance Abuse Treatment: A Multilevel Approach
Individual and organizational variables influence attitudes towards use of naltrexone, methadone, and buprenorphine for the treatment of alcohol and drug disorders. Prior research has not considered both sets of influences simultaneously. Hierarchical linear modeling tested the contribution of individual and organizational variables using data the National Drug Abuse Treatment Clinical Trials Network treatment unit and workforce surveys (n = 2,269 staff nested within 247 treatment units), done as part of protocol CTN-0008, "Assessment of the National Drug Abuse Clinical Trials Network: A Baseline for Investigating Diffusion of Innovation." Individual-level variables consistently had more influence on attitudes, but a unique blend of variables existed for each medication. One predictor, support for psychiatric medications, influenced attitudes across all medications. Staff attitudes towards addiction medications varied significantly between treatment units. Implications for increasing the appropriate use of addiction medications are discussed. Fitzgerald JP, McCarty D. Understanding attitudes toward use of medication in substance abuse treatment: a multilevel approach. Psychological Services. 2009;6(1):74-84.
Substance Abuse Treatment Clinician Opinions and Infectious Disease Service Delivery
Substance abuse treatment programs are an important platform for delivery of services for infectious diseases associated with drug and alcohol use. However, important components of infectious disease care are not universally provided. Clinician training often focuses on information about infectious diseases and less attention is paid to provider opinions and attitudes that may be barriers to providing infectious diseases services. In a national multi-site trial conducted by the National Drug Abuse Treatment Clinical Trials Network (CTN), the authors investigated the relationship between clinician opinions and the delivery of services for human immunodeficiency virus, hepatitis C virus, and sexually transmitted infections in substance abuse treatment settings. Survey data were collected from 1,723 clinicians at 269 CTN treatment programs. Clinician opinion was found to be significantly related to infectious disease service delivery. Implications for training are discussed. Tracy K, Brown LS, Kritz S, Alderson D, Robinson J, Bini EJ, Levy M, Calsyn D, Rieckmann T, Fuller B, McAuliffe P, Rotrosen J. Substance abuse treatment clinician opinions and infectious disease service delivery. J Addict Dis. 2009;28(1):8-12.
Correlates of Stimulant Treatment Outcome Across Treatment Modalities
This study evaluated variables associated with stimulant use outcomes in stimulant users (N = 800) receiving care in community outpatient psychosocial or methadone maintenance treatment clinics as part of a national multi-site clinical trial. Results from the full sample were examined first, and then predictors were examined separately in the two treatment modalities. A cocaine-positive urine sample at study intake was the most robust and consistent correlate of stimulant use outcome in all analyses. Psychiatric distress, social environment and employment had differential effects on outcome across modalities. This study confirms that intake assessments have considerable value in identifying problems to be addressed in treatment. Peirce JM, Petry NM, Roll JM, Kolodner K, Krasnansky J, Stabile PQ, Brown C, Stitzer ML. Correlates of stimulant treatment outcome across treatment modalities. Am J Drug Alcohol Abuse. 2009;35(1):48-53.
Factor Structure of the Condoms Barriers Scale with a Sample of Men at High Risk for HIV
This study assesses the psychometric properties of the Condom Barriers Scale (CBS), an instrument originally designed to measure womenÕs perceptions and attitudes regarding male condom use, with a sample of men at high risk for human immunodeficiency virus (HIV). Participants include 590 male patients in drug abuse treatment involved in a gender-specific HIV prevention intervention for teaching safer sex skills (protocol CTN-0018). Second-order confirmatory factor analysis generally supported the underlying four-factor subscale structure of the CBS. However, exploratory factor analysis revealed a few specific discrepancies in the factor structure between men and women. Internal consistency and test-retest reliability estimates were moderate to high in value. CBS scores correlated with use of condoms for men with high-risk sexual partners, supporting criterion-related validity. Overall, the analysis indicates that the CBS is a potentially valid and reliable instrument and has utility for assessing barriers to condom use with men, but may need some item content modifications to allow appropriate assessment of gender differences and comparisons across studies. Doyle SR, Calsyn DA, Ball SA. Factor structure of the Condoms Barriers Scale with a sample of men at high risk for HIV. Assessment. 2009;16(1):3-15. Epub 2008 Aug 8.
Motivation Enhancement Therapy with Pregnant Substance-Abusing Women: Does Baseline Motivation Moderate Efficacy?
Some evidence suggests that motivational approaches are less efficacious--or even counter-productive--with persons who are relatively motivated at baseline. The present study was conducted to examine whether disordinal moderation by baseline motivation could partially explain negative findings in a previous study [Winhusen T, Kropp F, Babcock D, Hague D, Erickson SJ, Renz C, Rau L, Lewis D, Leimberger J, Somoza E. Motivational enhancement therapy to improve treatment utilization and outcome in pregnant substance users. J Subst Abuse Treat. 2008;35:161-173]. Analyses also focused on the relative utility of the University of Rhode Island Change Assessment (URICA) scale, vs. a single goal question as potential moderators of Motivation Enhancement Therapy (MET). Participants were 200 pregnant women presenting for substance abuse treatment at one of four sites. Women were randomly assigned to either a three-session MET condition or treatment as usual (TAU). Generalized Estimating Equations (GEE) revealed no significant moderation effects on drug use at post-treatment. At follow-up, contrary to expectations, participants who had not set a clear quit goal at baseline were less likely to be drug-free if randomized to MET (OR=0.48); participants who did set a clear quit goal were more likely to be drug-free if randomized to MET (OR=2.53). No moderating effects were identified via the URICA. Disordinal moderation of MET efficacy by baseline motivation may have contributed somewhat to the negative results of the [Winhusen T, Kropp F, Babcock D, Hague D, Erickson SJ, Renz C, Rau L, Lewis D, Leimberger J, Somoza E.. Motivational enhancement therapy to improve treatment utilization and outcome in pregnant substance users. J Subst Abuse Treat. 2008;35:161-173] study, but in the opposite direction expected. A simple question regarding intent to quit may be useful in identifying persons who may differentially respond to motivational interventions. However, moderation effects are unstable, may be best identified with alternate methodologies, and may operate differently among pregnant women. Ondersma SJ, Winhusen T, Erickson SJ, Stine SM, Wang Y. Motivation Enhancement Therapy with pregnant substance-abusing women: does baseline motivation moderate efficacy? Drug Alcohol Depend. 2009;101(1-2):74-9. Epub 2008 Dec 19.
Construct, Concurrent and Predictive Validity of the URICA: Data from Two Multi-Site Clinical Trials
A better understanding of how to measure motivation to change and how it relates to behavior change in patients with drug and alcohol dependence would broaden our understanding of the role of motivation in addiction treatment. Two multi-site, randomized clinical trials comparing brief motivational interventions with standard care were conducted in the National Institute on Drug Abuse Clinical Trials Network. Patients with primary drug dependence and alcohol dependence entering outpatient treatment participated in a study of either Motivational Enhancement Therapy (n=431) or Motivational Interviewing (n=423). The construct, concurrent, and predictive validity of two composite measures of motivation to change derived from the University of Rhode Island Change Assessment (URICA): Readiness to Change (RTC) and Committed Action (CA) were evaluated. Confirmatory factor analysis confirmed the a priori factor structure of the URICA. RTC was significantly associated with measures of addiction severity at baseline (r=.12-.52, p<.05). Although statistically significant (p<.01), the correlations between treatment outcomes and RTC were low (r=-.15 and -18). Additional analyses did not support a moderating or mediating effect of motivation on treatment retention or substance use. The construct validity of the URICA was confirmed separately in a large sample of drug- and alcohol-dependent patients. However, evidence for the predictive validity of composite scores was very limited and there were no moderating or mediating effects of either measure on treatment outcome. Thus, increased motivation to change, as measured by the composite scores of motivation derived from the URICA, does not appear to influence treatment outcome. Field CA, Adinoff B, Harris TR, Ball SA, Carroll KM. Construct, concurrent and predictive validity of the URICA: data from two multi-site clinical trials. Drug Alcohol Depend. 2009;101(1-2):115-23. Epub 2009 Jan 20.
Supervision Mediates Counselor Burnout
Extends previous research on emotional exhaustion and turnover intention among counselors by estimating the associations between clinical supervision and these variables in a large national sample (N = 823) drawn from the NIDA Clinical Trials Network. Clinical supervision was negatively associated with both emotional exhaustion and turnover intention (RMSEA =.037, SRMR = .042; chi-square=1873.64, df = 878, p<.001), accounting for 31% of the variance in exhaustion reports, and 46% of intent to quit. Perceived quality of clinical supervision was strongly associated with counselors' perceptions of job autonomy, procedural justice, and distributive justice, which are, in turn, associated with emotional exhaustion and turnover intention. These data offer support for the protective role of clinical supervision in substance abuse treatment counselors' turnover and occupational well-being. Knudsen HK, Ducharme LJ, Roman PM. Clinical supervision, emotional exhaustion, and turnover intention: a study of substance abuse treatment counselors in the Clinical Trials Network of the National Institute on Drug Abuse. J Subst Abuse Treat. 2008;35:387-95.