Search the Library

Abstract: This study aimed to assess the validity of the psychiatric problems subscale of the Addiction Severity Index (ASI-psych) to ascertain psychiatric comorbidity among individuals participating in randomized controlled trials (RCTs) of substance use disorder (SUD) treatments. The ASI-psych score among 1,660 RCT participants of National Institute of Drug Abuse Clinical Trials Network studies was compared against diagnosis of any serious mental disorder based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (SCID) or Mini-International Neuropsychiatric Interview (MINI). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) for detecting any serious mental disorders were estimated by the receiver operating characteristic (ROC) analysis. Based on the overall sample, the AUC score for any serious mental disorder was 0.72 (95% confidence interval [CI], [0.69, 0.75]) with the optimal ASI-psych score of 24.6. There was no statistically significant difference in AUCs based on the SCID and MINI or by target drugs of RCTs. Conclusions: Results support the utility of the ASI in screening for psychiatric comorbidity among patients receiving SUD treatments in RCT settings. Related protocols: CTN-0005, CTN-0037

Abstract:

The extent to which behavioral drug abuse treatments affect sexual risk behaviors is largely unknown. This study examined the impact of behavioral drug abuse treatments on sexual risk behaviors using an integrative data analysis approach across eight trials conducted within the NIDA Clinical Trials Network (CTN-0004, 0005, 0006, 0007, 0009, 0013, 0015, and 0021). Participants (N=1305) from eight randomized controlled trials who were sexually active at baseline were included in the pooled dataset; 48.7% were female, 64.1% self-identified as a racial/ethnic minority, with M (SD) age of 34.9 (9.6). Longitudinal logistic regression estimated the probability of risky sexual behavior (i.e., inconsistent condom use and/or > 1 sexual partner in past 30 days) post-intervention with an indicator variable (1 for post-intervention), study condition (control, intervention), and their interaction as predictors; the analysis employed random effects for each trial and included relevant control variables. Time-varying differences in effects based on weeks post-intervention were incorporated using interacted linear and quadratic terms with condition status. Approximately 84.2% reported risky sexual behaviors at baseline. The control and intervention conditions were 18.5 and 17.3 percentage points less likely to report risky sexual behavior post-intervention, respectively.

Conclusions: Results suggest decreasing rates of risky sex engagement until 8 weeks (control) or 9 weeks (intervention post-intervention; risky sexual behavior subsequently increased. Behavioral CTN trial participation was associated with decreased sexual risk behaviors in both the intervention and control trial conditions. Given the heterogeneity of treatment approaches employed across the 8 CTN trials, these results point to the effectiveness of behavioral drug abuse treatment to reduce sexual risk behaviors. To bolster further reductions in sexual risk behavior engagement, there is a need to identify HIV risk reduction interventions that can best be integrated within existing resource-limited substance use disorder treatment programs.

Related protocols: CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0009, CTN-0013, CTN-0015, CTN-0021

Abstract:

It is reasonable to consider family discord after treatment as a potential target for a next-step intervention, since family discord is often comorbid with substance use disorders. This study evaluated family discord after completing an initial course of treatment as a predictor of substance use and retention in the community treatment program during follow-up. Patients were from two multisite randomized clinical trials implemented through the NIDA Clinical Trials Network (CTN-0004 and CTN-0005). There were 315 participants from Study 1 (12-week posttreatment follow-up) and 295 participants from Study 2 (8-week posttreatment follow-up). Negative binomial and logistic regression were used to estimate days of substance use and odds of retention in the community treatment program at follow-up, respectively, from family discord status.

Results found that participants experiencing family discord reported significantly more days of substance use during the posttreatment follow-up period than those who did not experience family discord in both Study 1 (9.12 vs. 2.89 days, p=.0001) and Study 2 (5.58 vs. 2.83 days, p=.0062). Family discord was significantly associated with lower retention in the community treatment program at follow-up in Study 1 (47.6% vs. 60.6%; p=.03), but not in Study 2 (55.3% vs. 64.9%; p=.11).

Conclusions: Family discord after an initial course of treatment might be a clinically relevant predictor of substance use. There is mixed support for a conclusion that family discord is associated with lower retention in the community treatment program at follow-up. Family discord warrants assessment after an initial course of treatment and may be a useful target for adaptive treatment intervention.

Related protocols: CTN-0004, CTN-0005

Abstract:

In case multiple treatment alternatives are available for some medical problem, the detection of treatment-subgroup interactions (i.e., relative treatment effectiveness varying over subgroups of persons) is of key importance for personalized medicine and the development of optimal treatment strategies. Randomized clinical trials (RCTs) often go without clear a priori hypotheses on the subgroups involved in treatment-subgroup interactions, and with a large number of pre-treatment characteristics in the data. In such situations, relevant subgroups (defined in terms of pre-treatment characteristics) are to be induced during the actual data analysis. This comes down to a problem of cluster analysis, with the goal of this analysis being to find clusters of persons that are involved in meaningful treatment-person cluster interactions. For such a cluster analysis, five recently proposed methods can be used, all being of a recursive partitioning type. However, these five methods have been developed almost independently, and the relations between them are not yet understood.

This paper aims to close that gap. It starts by outlining the basic principles behind each method, and by illustrating it with an application on a data set from an RCT in the National Drug Abuse Treatment Clinical Trials Network that evaluated two treatment strategies for substance abuse problems (CTN-0005, “Motivational Interviewing (MI) to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse”). Next, it presents a comparison of the methods, focusing on major similarities and differences. The discussion concludes with practical advice for end users with regard to the selection of a suitable method, and with an important challenge for future research in this area.

Related protocols: CTN-0005

Abstract:

HIV infection disproportionately impacts minorities, yet research on racial/ethnic differences in the prevalence and correlates of HIV risk behaviors is limited. This study examined racial/ethnic differences in the rates of HIV risk behaviors and whether the relationship between HIV risk factors and HIV risk behaviors varies by race/ethnicity in clients participating in National Drug Abuse Treatment Clinical Trial Network (CTN) trials. The sample was 41% non-Hispanic White, 32% non-Hispanic Black, and 27% Hispanic (N = 2,063). HIV risk behaviors and measures of substance and psychosocial HIV risk factors in the past month were obtained. Non-Hispanic Blacks engaged in less HIV sexual risk behaviors overall than non-Hispanic Whites. While non-Hispanic Whites were the most likely to report any injection drug use, Hispanics engaged in the most HIV drug risk behaviors. Specific risk factors were differentially predictive of HIV risk behavior by race/ethnicity. Alcohol use severity was related to engaging in higher sex risk behaviors for non-Hispanic Blacks and Whites. Greater psychiatric severity was related to engaging in higher sex risk behaviors for non-Hispanic Whites. Drug use severity was associated with engaging in higher risk drug behaviors for non-Hispanic Whites and Hispanics, with the magnitude of the relationship stronger for Hispanics.

Conclusions: The findings from the present study suggest that there is a context in which HIV high risk behaviors occur within racial/ethnic groups as well as differences in the presence of risk factors associated with engaging in those behaviors. These findings are consistent with calls to culturally adapt evidence-based interventions and the need to maintain core elements of the intervention when adapting the intervention for increased relevance to the new targets. Further research testing HIV risk prevention interventions within racial/ethnic groups is needed to identify target behaviors or risk factors that are salient to inform HIV interventions.

Related protocols: CTN-0001, CTN-0002, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0021

Abstract:

This study sought to examine the psychometric properties of a revised version of the SIP (SIP-R) as a measure of adverse consequences for alcohol and drug users in both English and Spanish-speaking populations. The English version was evaluated within a large population of alcohol and drug abuse treatment seekers (N=886) pooled from two national, multisite randomized trials (protocols CTN-0004 and -0005). It was also translated into Spanish and evaluated in a large population of Spanish-speaking substance abuse treatment seekers (N=405) participating in a separate multisite randomized trial (CTN-0021). All trials utilized a common assessment battery that included the ASI, the URICA, and a substance use calendar. Reliability and validity analyses included internal consistency, confirmatory factor analysis, and correlations. Differences in reported consequences were explored using ANOVA. For the English version, results supported the internal consistency and theoretical five-factor structure. Convergent validity was evident through strong correlations with the URICA and the drug composite score from the ASI, whereas weak correlations with other composite scores provided evidence of discriminant validity. Results for the Spanish version were highly similar, with strong internal consistency, factor structure, and a similar pattern of correlations with the ASI and URICA. In both the English and Spanish-speaking samples, baseline SIP-R total scores were higher for those not legally mandated to treatment and were associated with days retained in treatment.

Conclusions: This is the first study to evaluate the SIP-R within such a large, diverse sample of treatment seekers, including evaluation of a Spanish version. Both the English and Spanish versions of the SIP-R demonstrated strong psychometric properties and should be considered a valuable measure of adverse consequences associated with drug and alcohol use.

Related protocols: CTN-0004, CTN-0005, CTN-0021

Abstract:

Assessment of the adverse consequences of substance use serves an important function in both clinical and research settings, yet there is no universally agreed upon measure of consequences relevant to multiple types of substance use disorders. One of the most commonly used measures, the Short Inventory of Problems (SIP), has been adapted and evaluated in several specific populations, but evidence is needed of its reliability and validity across broader samples of persons with substance use disorders. This study evaluated the psychometric properties of a revised version of the SIP (SIP-R) in a large combined sample of alcohol and drug use disorder treatment seekers, with participants pooled from two studies from the National Drug Abuse Treatment Clinical Trials Network (CTN-0004, about motivational enhancement therapy, and CTN-0005, about motivational interviewing).

A total of 886 participants across 10 outpatient treatment facilities completed a common assessment battery that included the SIP-R, Addiction Severity Index (ASI), University of Rhode Island Change Assessment (URICA), HIV Risk Behavior Scale (HRBS), and a substance use calendar. Results supported the SIP-R’s internal reliability (alpha = .95). Confirmatory factor analysis demonstrated that the hypothesized 5-factor model with one higher-order factor produced the best fit. Convergent validity was evident through the SIP-R’s correlation with several composite scores from the ASI and the URICA, and analyses supported its conceptual distinction from quantity indices of drug/alcohol use. The SIP-R also demonstrated an ability to predict treatment retention, with higher scores associated with poorer retention.

Conclusions: These results provide support for the SIP-R’s psychometric properties as a measure of consequences across a broad sample of treatment-seeking drug and alcohol users.

Related protocols: CTN-0004, CTN-0005

Abstract:

Selection of appropriate outcome measures is important for clinical studies of drug addiction treatment. Researchers use various methods for collecting drug use outcomes and must consider substances to be included in a urine drug screen (UDS), accuracy of self-report, use of various instruments and procedures for collecting self-reported drug use, and timing of outcome assessments. This study sought to define a set of candidate measures to (1) assess their intercorrelation and (2) identify any differences in results. To that end, data were combined from seven completed protocols in the National Drug Abuse Treatment Clinical Trials Network (CTN), with a total of 1897 participants. Nine outcome measures were defined, based on UDS, self-report, or a combination, then multivariable, multilevel generalized estimating equation models were used to assess subgroup differences in intervention success, controlling for baseline differences and accounting for clustering by CTN protocols. Results found high correlations among all candidate outcomes. All outcomes showed consistent overall results with no significant intervention impact on drug use during follow-up. However, with most UDS variables, but not with self-report or “corrected self-report,” a significant gender–ethnicity interaction with benefit shown in African American women, White women, and Hispanic men was observed.

Conclusions: Despite strong associations between candidate measures, important differences in results were found. This study demonstrates the potential utility and impact of combining UDS and self-report data for drug use assessment. The results suggest possible differences in intervention efficacy by gender and ethnicity, but highlight the need to cautiously interpret observed interactions. Additional studies like this one will help guide implementation of methodological recommendations to construct combined measures.

Abstract:

This set of slides features presentations from a symposium at the 2011 APA convention that focused on substance use treatment with ethnic minorities in the National Drug Abuse Treatment Clinical Trials Network. It begins with an overview of the CTN and its aim to improve substance abuse treatment by bridging the gap between practice and research, and then continues with presentations on a variety of ancillary investigations of CTN protocols: a comparison of gender, race/ethnicity, and age groups in people participating in CTN studies; racial/ethnic differences in the rates and correlates of HIV risk behaviors among drug abusers; the relation of racial/ethnic matching to engagement, retention, and treatment outcomes for adolescent substance users; and the relationship between therapist and patient gender/race-matching and substance use outcomes in two motivational therapy trials (CTN-0004 and CTN-0021). Results from each ancillary investigation are presented, along with discussion of the outcomes and study limitations.

Related protocols: CTN-0001, CTN-0002, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0014, CTN-0021

Abstract:

This poster describes a study that aimed to identify for whom brief, motivation-enhancing interventions for substance use are effective, using exploratory secondary analyses of the combined datasets from four randomized National Drug Abuse Treatment Clinical Trials Network protocols (CTN-0004, -0005, -0013, and -0021) examining Motivational Interviewing / Motivational Enhancement Therapy versus Counseling as Usual (CAU). Participants were randomized to individual sessions of CAU or MET (3 sessions) / MI (1 session, CTN-0005). Other outpatient group treatment was provided as usual. All studies assessed post-intervention outcomes 4 weeks post-randomization. Participants (N=1520) were recruited from 18 outpatient treatment programs across the U.S. The majority (75%) were never married, divorced, separated, or widowed; 37% were Caucasian; and 37% were female. Almost half (40%) had a positive UDS at baseline. The MET/MI (TRT; n = 741) and CAU (n = 779) conditions were collapsed across studies and both groups were analyzed separately using direct logistic regression. There were no specific hypotheses about the order or importance of the predictors. Hispanic participants had significantly lower odds of first session completion compared to Caucasians. In both groups, positive UDS at baseline and higher Addiction Severity Index (ASI) Employment Problems scores were significantly associated with lower odds of completing three sessions. For both the TRT and CAU groups, positive UDS at baseline, higher ASI Drug Use scores, and higher ASI Medical Problems scores were significantly associated with lower odds of abstinence at end-of-treatment. Results indicate clients most in need of drug use treatment (those who have used near treatment entry and have greater drug use, medical problem, and employment problem severity), are less likely to complete or benefit from outpatient treatment as usual or outpatient treatment with motivation enhancement. These results may indicate a higher level of care is more appropriate for clients with more severe drug use problems. Additional research is needed to determine if more MET sessions earlier in treatment can positively impact treatment attendance and abstinence outcomes.

Related protocols: CTN-0004, CTN-0005, CTN-0013, CTN-0021

Abstract:

The National Drug Abuse Treatment Clinical Trials Network (CTN) has faced many challenges over its first eleven years. This review explores some of these challenges and the paths the CTN took to meet these challenges, including: designing clinical trials that reflect the CTN’s mission and changing public health needs, finding the synergies in the varied expertise of clinical treatment providers and academic researchers, promoting evidence-based practices, and expanding the Network into mainstream medical practices to reach a broader patient population. Included in this exploration are specific examples from CTN clinical trials.

CTN studies have shown that quality clinical trials can be successfully implemented into practice settings unfamiliar with research logistics by taking clinicians’ practical needs and research knowledge level into account. The challenges yet to be faced in the CTN’s efforts to expand opportunities to offer existing treatments to the segment of the drug-abusing population that utilizes mainstream health care seem large, but not as large as the potential for improvements in public health.

Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0009, CTN-0010, CTN-0011, CTN-0013, CTN-0014, CTN-0015, CTN-0017, CTN-0018, CTN-0019, CTN-0020, CTN-0021, CTN-0027, CTN-0028, CTN-0029, CTN-0030, CTN-0031, CTN-0032, CTN-0037, CTCN-0044, CTN-0047, CTN-0048, CTN-0049

Abstract:

Teaching community program therapists to use motivational interviewing (MI) strategies for addictions treatment with sufficient frequency (i.e., adherence) and skill (i.e., competence) is a priority and challenge for the field. The development of psychometrically valid MI integrity measures that can be used for supervision and evaluation and be both sensitive and robust across clinical situations is needed. This article examines the performance of the Independent Tape Rating Scale (ITRS) when used within a National Drug Abuse Treatment Clinical Trials Network (CTN) protocol (CTN-0005) that incorporated MI into a one-session assessment intake, and compares the effectiveness of an MI assessment to a counseling-as-usual intake.

Results indicate that community therapists were successfully trained and supervised to use MI within an assessment intake session, with MI adherence and competence that was discriminable from counseling-as-usual practices. Increased therapist MI adherence and competence was associated with increases in an index of client motivation for change, though unrelated to treatment outcome. The ITRS appears to be a valid instrument for measuring therapist MI adherence and competence within an assessment intake.

Related protocols: CTN-0005

Abstract:

What kind of training is needed for what type of clinician to deliver what type of therapy? An article in Clinical Psychology: Science and Practice by Beidas and Kendall (“Training Therapists in Evidence-Based Practices: A Critical Review of Studies from a Systems-Contextual Perspective,” 2010;17:1-30) featured well-considered recommendations for further research into systematic strategies for training clinicians to utilize evidence-based treatments, highlighting the limitations of didactic training alone (without supervision, fidelity monitoring, and feedback) in conferring specific skills to clinicians.

To further amplify some of the points made, this article summarizes findings from a recent series of platform/ancillary studies in the National Drug Abuse Treatment Clinical Trials Network which evaluated the impact of training and supervision of clinicians using motivational interviewing (MI) in protocols CTN-0004, CTN-0005, and CTN-0021. In particular, review of tapes from the “treatment as usual” conditions in those studies suggests that (a) delivery of interventions associated with evidence-based treatment was infrequent; (b) clinicians overestimated the time spent on evidence-based interventions, and (c) ongoing supervision and performance-based feedback appear to suppress time spent in session on discourse unrelated to the patient’s problems and concerns. This article also discusses computer-assisted treatment and computer-assisted clinician training as important new tools for disseminating evidence-based therapies.

Related protocols: CTN-0004, CTN-0005, CTN-0021

Abstract:

The National Drug Abuse Treatment Clinical Trials Network (CTN) is designed to test drug abuse treatment interventions in multisite clinical trials and to support the translation of effective interventions into practice. This study used qualitative methods to examine adoption of motivational interviewing and motivational enhancement therapy (MI/MET) in five clinics (CTPs) in the western US where those interventions were tested (as part of protocols CTN-0004 and CTN-0005). Participants were clinic staff who were interviewed about the MI/MET study, and about whether MI/MET was adopted after the study ended. The study found that despite the fact participation in the trials created a number of conditions supportive of adoption, a range of adoption outcomes was found: full “adoption” in one clinic, “partial adoption” in one clinic, “counselor adoption” in one clinic, and “no adoption” in two clinics. These findings highlight a distinction between adoption at the organizational and counselor levels, and suggest that a range of outcomes may be observed in the field, which may have implications for state- or other mandates for adoption of evidence-based practices. Sustained implementation of evidence-based practices, in many programs, likely requires external support from county or other healthcare treatment systems, state-funded drug abuse treatment systems, or federal agencies, and support in the form of policy leadership or guidance, regulatory or funding mandates, or changes in reimbursement strategies that enable and support evidence-based practices.

Related protocols: CTN-0004, CTN-0005

Abstract:

Participant retention is critically important for clinical research studies in the area of addictions. This study, using data from fifteen trials in the National Drug Abuse Treatment Clinical Trials Network, sought to examine predictors of retention in a series of treatment outcome studies. Studies were combined, defining retention through the final follow-up visit, and multivariate logistic regression models were used to assess predictors of study retention, focusing on age, gender, and ethnicity (non-Hispanic White, African American, and Hispanic/Other). Results found no clear pattern, however retention seemed higher in adult pharmacologic trials and lower in sexual risk reduction trials. Younger participants were more likely to drop out and, in comparison to African American participants, non-Hispanic Whites were more likely and Hispanic/Others less likely, to drop out. In terms of gender, no significant difference was found between the sexes, though a significant interaction was discovered between ethnicity and gender in relation to study retention. This interaction was largely driven by Hispanic/Other women (not in methadone treatment), who were approximately 40% less likely to be lost to follow-up than their African American counterparts. The results suggest that strategies focused on improving study retention in younger subjects, and in non-Hispanic females, may be particularly important for increasing participant retention and improving the validity of clinical trial data.

Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0009, CTN-0010, CTN-0011, CTN-0013, CTN-0015, CTN-0018, CTN-0019, CTN-0021