Search the Library

Abstract: High levels of missing outcome data for biologically confirmed substance use (BCSU) threaten the validity of substance use disorder (SUD) clinical trials. Underlying attributes of clinical trials could explain BCSU missingness and identify targets for improved trial design. We reviewed 21 clinical trials funded by the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) and published from 2005 to 2018 that examined pharmacologic and psychosocial interventions for SUD. We used configurational analysis-a Boolean algebra approach that identifies an attribute or combination of attributes predictive of an outcome-to identify trial design features and participant characteristics associated with high levels of BCSU missingness. Associations were identified by configuration complexity, consistency, coverage, and robustness. We limited results using a consistency threshold of 0.75 and summarized model fit using the product of consistency and coverage. For trial design features, the final solution consisted of two pathways: psychosocial treatment as a trial intervention OR larger trial arm size (complexity=2, consistency=0.79, coverage=0.93, robustness score=0.71). For participant characteristics, the final solution consisted of two pathways: interventions targeting individuals with poly- or nonspecific substance use OR younger age (complexity=2, consistency=0.75, coverage=0.86, robustness score=1.00). Conclusions: Psychosocial treatments, larger trial arm size, interventions targeting individuals with poly- or nonspecific substance use, and younger age among trial participants were predictive of missing BCSU data in SUD clinical trials. Interventions to mitigate missing data that focus on these attributes may reduce threats to validity and improve utility of SUD clinical trials. Related protocols: CTN-0002, CTN-0003, CTN-0004, CTN-0006, CTN-0007, CTN-0009. CTN-0013, CTN-0014, CTN-0015, CTN-0017, CTN-0021, CTN-0029, CTN-0030, CTN-0031, CTN-0037, CTN-0044, CTN-0046, CTN-0048, CTN-0051, CTN-0053

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:

Smoking is highly prevalent among individuals with drug and alcohol disorders. Concurrent tobacco dependence treatment during substance use disorder (SUD) treatment is supported yet the association between SUD treatment outcomes and smoking status has been understudied in minorities, including Latinos. Participants in this study were 322 Spanish-speaking Latinos enrolled in a substance use disorder treatment study in five U.S. cities, NIDA Clinical Trials Network protocol CTN-0021 (“Motivational Enhancement Treatment to Improve Treatment Engagement and Outcome for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse”). Logistic regression examined associations between baseline smoking status and treatment outcomes for nontobacco substance use at follow-up. Covariates included age, gender, level of education, marital status, treatment group, and mandated treatment status.

Results indicated being a smoker during the first month of substance use treatment is associated with a significant increase in the odds of substance use relapse at follow-up. Smokers had a reduced likelihood of abstinence for all nontobacco substances and their primary drug of use.

Conclusions: The current study provides further evidence for the association between smoking status and substance use treatment outcomes. Findings contribute to the growing literature indicating a possible beneficial effect of smoking cessation services on SUD treatment, specifically among Latinos. They could, in fact, serve as a rationale for a conceptual shift with respect to how smoking is perceived and managed during SUD treatment; instead of seeing smoking as a comorbid “addiction,” a more progressive view might see it as conceptually inseparable from the full range of psychosocial factors, including other substance use and mental health conditions. Further research is needed to identify ideal smoking cessation treatments for Latinos.

Related protocols: CTN-0021

Abstract:

This ancillary investigation of data from NIDA Clinical Trials Network protocol CTN-0021 explored Hispanic subgroup differences in substance use treatment outcomes, and the relationship of acculturation characteristics to these outcomes. Data were from a multisite randomized clinical trial of motivational enhancement therapy versus treatment as usual in a sample of Spanish-speaking substance abusers. Participants were Cuban American (n=34), Mexican American (n=209), Puerto Rican (n=78), and other Hispanic American (n=54). Results suggested that Cuban Americans and individuals with more connection to Hispanic culture had lower treatment retention. Hispanics born in the U.S. and those who spoke English at home had a lower percentage of days abstinent during weeks 5-16, although Puerto Ricans born in the U.S. and Cuban Americans living more years in the U.S. had a higher percentage of days abstinent in weeks 1-4 and 5-16, respectively.

Conclusions: This study’s analysis of treatment outcomes and acculturation disaggregated by Hispanic subgroup begins to fill an important and large gap in the substance abuse treatment research literature. Results found that Cuban Americans and individuals with more connection to the Hispanic culture had lower treatment retention, and that acculturation measures such as U.S. birthplace and years living in the U.S. were associated with reduced abstinence in some but not other Hispanic subgroups. These findings provide evidence that the relationships between acculturation and abstinence outcomes are likely complicated and varied across Hispanic groups. Results may inform future hypothesis-driven studies in larger Hispanic treatment seeking samples of the relationship between acculturation and treatment outcome.

Related protocols: CTN-0021

Abstract:

In order to determine if expectations at pre-treatment are associated with substance use treatment outcomes, this study examined treatment expectations in two National Drug Abuse Treatment Clinical Trials Network (CTN) randomized controlled trials (RCTs) utilizing Motivational Enhancement Therapy (MET) for the treatment of substance use (CTN-0004 and CTN-0021). One RCT was delivered in English (MET-E) and one was delivered in Spanish (MET-S). There were 461 participants MET-E sample and 405 participants MET-S. Participants responded to the following item at pre-treatment: “Do you think you will reduce or stop your use of drugs or alcohol as a result of this treatment?” ANOVAs and chisquare tests were used to examine the relationship between treatment expectations and treatment outcomes in the two samples.

Treatment expectations were not associated with any of the treatment outcomes in MET-E. However, in MET-S, expectations were significantly associated with most of the post-treatment outcomes. Among these, treatment expectations were significantly associated with the percentage of drug positive urines within the treatment period, F (1, 1,163) = 18.83, p = .000, and the percentage of days abstinent from primary drug use while in treatment and through follow-up, F (1, 1,364) = 23.78, p = .000.

Conclusions: There are several possible interpretations to the divergent findings between samples. The first is that the MET-S sample had fewer previous treatments, and that when a treatment is novel, expectations may have more of an influence. The second interpretation is that there may be cultural components that may affect how an individual relates to the treatment process. These findings are preliminary and future research should examine treatment expectations across cultures.

Related protocols: CTN-0004, CTN-0021

Abstract:

Latino Americans report underutilization of treatment and poor treatment response for substance use and abuse compared to other racial/ethnic groups; thus, it is important to assess factors that contribute to these disparities. The current study, an ancillary investigation of data from a National Drug Abuse Treatment Clinical Trials Network (CTN) study about Motivational Enhancement Treatment for Spanish-speaking individuals (CTN-0021), aimed to assess the influence of family conflict on substance abuse treatment response in a sample of Latino Americans using two different yet complementary analyses. First, ordinary least squares regression was used to assess the association between overall family conflict and pre- and post-treatment substance use. Second, repeated measures latent class analysis was used to identify groups based on family member conflict and timing of conflict during treatment. Findings indicated that family conflict contributed unique variance to concurrent substance use; however, pre-treatment family conflict was not related to post-treatment outcomes. Results also identified three distinct family conflict groups: no/low conflict, pre-treatment conflict, and post-treatment conflict who differed in pre- and post-treatment substance use. Post hoc investigation revealed that those who experienced pre-treatment conflict but low post-treatment conflict showed the greatest decrease in substance use.

Conclusions: Overall, findings suggest that for Latinos it may be beneficial for substance abuse treatment programs not only to screen and assess family conflict at intake, but to continue this assessment at follow-up. The assessment of family conflict post-treatment could identify individuals more at risk for relapse. Additionally, it may benefit substance abuse practitioners to regularly address family conflict when working with Latinos as those who reported the greatest change in family conflict from pre- to post-treatment also reported the greatest decrease in substance use at post-treatment follow-up. These findings, coupled with previous research highlighting the importance of family cohesion in Latino mental health and treatment outcomes, suggest that incorporating family members or family-based curriculum into treatment may help address family conflict in a way that improves Latino substance use outcomes.

Related protocols: CTN-0021

Abstract:

Baseline patients’ characteristics are critical for treatment planning, as these can be moderators of treatment effects. In Mexico, information on treatment seekers with substance use disorders is scarce and limited to demographic characteristics. This paper presents and analyses demographic characteristics, substance use related problems, clinical features, and addiction severity in a sample of treatment seekers from the first multi-site randomized clinical trial implemented in the Mexican Clinical Trials Network on Addiction and Mental Health. The study was an adaptation of the U.S.’s National Drug Abuse Treatment Clinical Trials Network protocol CTN-0021, which evaluated the use of motivational enhancement treatment to improve treatment engagement and outcome for Spanish-speaking individuals seeking treatment for substance abuse.

A total of 120 participants were assessed prior to randomization. Chi square or F-tests were used to compare sites across variables. Spearman correlation was used to associate negative consequences of substance use and motivation to change. The majority of participants were men, and the most prevalent substances reported were alcohol, marijuana, and cocaine. Participants were predominantly on the contemplation or action stage of change, and this was correlated with the perception of the negative consequences associated with substance use. Participants reported a high prevalence of substance use related problems.

Conclusions: Data presented here constitutes the first attempt to characterize more widely the treatment-seeking population in outpatient addiction treatment settings in Mexico. Regardless of the limitations in sample size, this study uncovered special considerations that should be taken into account for outpatients in addiction treatment in Mexico, including substance use related problems, clinical features, and addiction severity. This study represents a novel approach to systematic assessment in addiction clinical studies in Mexico, and the establishment of the Mexican Clinical Trials Network on Addiction and Mental Health promises to help bridge the gap between research and practice and establish the opportunity for future implementation of evidence-based approaches in clinical practice and research.

Related protocols: CTN-0021

Abstract:

Hispanic Americans are substantially underrepresented in clinical and research samples for substance use treatment, with language cited as one of the major barriers to their participation, indicating a need for more validated assessments in Spanish. This study evaluated the psychometric properties of a Spanish version of the Short Inventory of Problems (SIP), used in a multisite, randomized trial conducted for Spanish-speaking substance users, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0021. The sample included 405 Spanish-speaking treatment seekers, mostly male (88%) and legally mandated to treatment (71%). The Spanish version of the revised SIP (SIP-RS), as well as other commonly used assessment measures translated into Spanish, were administered at baseline and at the end of treatment. Internal consistency was excellent and construct validity was supported through correlations with composite scores from the Addiction Severity Index (ASI) and through differential SIP-RS scores according to diagnostic criteria. The SIP-RS also demonstrated an association with substance use and treatment retention, with higher baseline scores associated with significantly less abstinence during treatment and fewer days retained in treatment. However, the latter association was moderate by participants’ legal status.

Conclusions: This Spanish-translated version of the SIP (SIP-RS) appears to be a reliable and valid assessment of adverse consequences associated with alcohol and drug use, with psychometric properties comparable with the English version. This assessment may prove to be a useful outcome measure for evaluating the efficacy of treatments for substance use disorders, and it may have the potential to identify individuals at risk for early treatment drop-out. Given the growing population of Hispanics in the United States with limited English proficiency, greater effort should be placed toward validating substance abuse assessment instruments for Spanish-speakers, with a particular focus on diverse Hispanic populations.

Related protocols: CTN-0021

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:

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:

Although some research supports patient/therapist similarity in developing a therapeutic alliance more successfully, findings are mixed. The aim of this study was to examine the moderating effects of gender/race matching between therapists and patients on alliance and substance use outcomes. Identical measures were obtained in two CTN trials of MET (CTN-0004 and CTN-0021). Participants were patients (valid N=344) and therapists (valid N=24) participating in these trials who had complete data from the HAQ-II (measuring therapeutic alliance), ASI-Lite data at baseline and week 4 (post-treatment), and indicated perceptions of their provider’s race and gender on a post-treatment questionnaire. The authors hypothesized that patients’ perception of their therapists’ race and gender would (1) affect post-treatment substance use, and (2) moderate the relationship between therapeutic alliance, defined by patient and therapist scores on the HAQ-II, and substance use. The relationship among the variables was examined. Racially matched patients reported significantly fewer days of drug use. However, racial match was unrelated to patient perceived alliance. When HAQ-II therapists’ scores were included in the model, racially matched patients again reported significantly fewer days of drug use. Race matching significantly moderated the relationship between the alliance perceived by therapists and substance use. Gender matched patients reported significantly more days of drug use even after HAQ-II therapists’ scores were included in the model. Gender similarity did not significantly affect the level of alliance indicated by patients or therapists. In conclusion, findings from this study support racial, but not gender, matching.

Related protocols: CTN-0004, 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:

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