Search the Library

Abstract: The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0004, a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. Contrary to the study hypothesis, MET did not appear to be more effective than CAU for either retention measure or urine drug outcome. However, though both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. MET also resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites. Although the researchers did not directly assess the efficacy of their training model, the results of this study and its companion single-session protocol (Carroll et al, 2006) indicated that community-based therapists can learn to deliver MET effectively even in the absence of a priori allegiance, interest, or training in the model. Future analyses will evaluate the relationship between therapist experience, skill, adherence, and treatment outcomes.

Abstract:

This paper reports on a cost-effectiveness study of protocol CTN-0007, designed to determine if prize-based contingency management (CM), which has been shown to improve treatment outcomes over usual care (UC) alone, is worth the additional cost to treatment agencies. Six methadone maintenance community-based treatment programs (CTPs) in the CTN participated, with a study sample of 388 participants, 190 in the UC condition and 198 in the CM condition (which combined usual care with contingency management).

The authors found that prize-based contingency management provided better patient outcomes than usual care, but required additional costs. Compared to usual care, the incremental cost of using prize-based contingency management to lengthen the longest duration of abstinence (LDA) by one week was $141. The incremental cost to obtain an additional stimulant-negative urine sample was $70. Whether this extra expenditure is worthwhile depends upon the value placed on these outcomes. Using only the benefit of averted crime, an acceptability curve developed by the authors demonstrates a cost-effectiveness benefit of 90%. However, this estimate is quite conservative because averted crime is only one of the many potential benefits of a reduction in substance abuse. By comparing this study to a companion study, the authors also found that adding prize-based contingency management to usual care may be more cost-effective in methadone maintenance clinics than in counseling-based drug-free clinics. Further empirical analyses are needed to help policy makers decide whether CM is worth the extra expense; this paper helps to build an empirical basis for these important decisions.

Related protocols: CTN-0007-A-2

Abstract:

Teleconferencing Supervision is a method for training community-based substance abuse clinicians in Motivational Interviewing (MI). In this CTN platform study, 13 clinicians recruited from 3 community treatment programs in the Long Island Node of the Clinical Trials Network attended a 2-day workshop and then received live supervision via telephone during 5 counseling sessions conducted at their community treatment facilities. Clinicians were assessed for skill level at post-workshop, at post-training, and 3 months later; learning was assessed using the MI Treatment Integrity instrument. All summary scores and therapist behavior frequency counts improved by post-training or by the 3 month follow-up, although some gains were not statistically significant.

This study suggests that Teleconferencing Supervision may help facilitate the proficient use of MI community clinicians following workshop instruction. By enabling both clinicians and supervisors to participate from their respective home bases, it is hoped that the TCS model will be able to project training to a broader range of community treatment programs.

Abstract:

This brochure, intended for clinicians participating in the CTN-0013 clinical trial (MET to Improve Treatment Utilization and Outcome in Pregnant Substance Users), provides an overview of Motivational Enhancement Therapy (MET) and answers to questions participants might have about being involved in the research project.

Abstract:

Although buprenorphine is an effective treatment for opioid use disorder (OUD), much remains to be understood about treatment non-response and methods for improving treatment retention. The addition of behavioral therapies to buprenorphine has not yielded consistent benefits for opioid outcomes, on average. However, several studies suggest that certain subgroups may benefit from the combination of buprenorphine and behavioral therapy, highlighting the potential for personalized approaches to treatment. Furthermore, little is known about whether behavioral therapies improve buprenorphine retention or non-opioid (e.g., functional) outcomes.

The objective of this project is to harmonize four previously conducted clinical trials, including three independent trials and one NIDA Clinical Trials network multi-site trial (CTN-0030), testing the addition of behavioral therapy to buprenorphine maintenance for OUD and to use this larger dataset to answer critical clinical questions about the role of behavioral therapy in this population. Study aims include identifying potential moderators of the effect of the addition of behavioral therapy and quantifying the effect of behavioral therapy on buprenorphine retention and functional outcomes.

Analyses will consider outcomes of weeks of opioid use, weeks of retention in buprenorphine treatment, and functional outcomes as measured by the Addiction Severity Index. Analyses will include an indicator for each study to account for heterogeneity of samples and design.

Conclusions: Results will help to inform clinical and research efforts to optimize the use of behavioral therapies in the treatment of OUD.

Related protocols: CTN-0030

Abstract:

Traditional treatments for substance use disorders (SUDs) rely heavily on face-to-face interactions, which pose substantial limitations for patients. A clinical trial of a digital therapeutic (DT) delivering behavioral therapy demonstrated safety and efficacy in a population including patients with opioid use disorder (OUD) not treatment with buprenorphine, which is not a guideline-recommended approach. This study re-analyzed the data excluding patients with OUD to more closely approximate real-world patient populations.

The study was a secondary analysis of data from CTN-0044 (“Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders;” n=399 after patients with OUD were excluded). Patients received 12 weeks of outpatient treatment-as-usual (TAU; n=193) or TAU with reduced counseling plus a digital therapeutic (DT; n=206) providing computerized cognitive behavioral therapy and contingency management (the reSET, a commercial version of the Therapeutic Education System (TES)). Primary outcomes were abstinence in weeks 9-12 and retention in treatment.

The 399 patients in the analysis (206 in the DT group and 193 in the TAU group) reported substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (e.g. methamphetamine). Demographic and baseline characteristics including age, sex, race, education, and reported primary substance use disorder were balanced between treatment groups. Abstinence was significantly higher in the DT group compared to the TAU group (40.3 vs. 17.6%), as was retention in therapy (76.2 vs. 63.2%).

Conclusions: These results demonstrate that use of a digital therapeutic safely increased abstinence (reduced substance use) and retention in treatment among patients with substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (including methamphetamines).

Related protocols: CTN-0044

Abstract:

Evidence-based interventions for treating opioid use disorder (OUD) in youth are limited and little is known about specific and general mechanisms of OUD treatments and how they promote abstinence. This study used data from the CTN-0010 trial to evaluate the mediating effects of psychosocial treatment-related variables (therapy dose and therapeutic alliance) on end-of-treatment opioid abstinence in a sample of youth with OUD (n=152, 40% female, mean age=19.7 years) randomized to receive either 12 weeks of treatment with Bup/Nal (“Bup-Nal”) or up to 2 weeks of Bup/Nal detoxification (“Detox”) with both treatment arms receiving weekly individual and group drug counseling +/- family therapy.

Participants in the Bup-Nal group attended more therapy sessions (16 vs 6 sessions), had increased therapeutic alliance at week 4, and had less opioid use by week 12 compared to those in the Detox group. In both treatment arms, youth who attended more therapy sessions were less likely to have a week 12 opioid positive urine. In a multiple mediator model, therapy dose mediated the association between treatment arm and opioid abstinence.

Conclusions: These findings provide preliminary support for a “dose-response” effect of addiction-focused therapy on abstinence in youth OUD. Further, the results identified a mediating effect of therapy dose on the relationship between treatment assignment and opioid treatment outcomes, suggesting that extended Bup-Nal treatment may enhance abstinence, in part, through a mechanism of therapy facilitation, by increasing therapy dose during treatment.

Related protocols: CTN-0010

Abstract:

Exercise is a promising treatment for stimulant use disorder. However, efficacy has not been clearly demonstrated in a general stimulant using population where response to exercise is expected to be heterogeneous. Thus, examination of response heterogeneity to identify subgroups for whom exercise is either clearly indicated or not indicated is of considerable interest as findings will support more effective tailoring of patient treatments in practice and guide future research in stimulant use disorder. A secondary analysis of the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) randomized controlled trial of 302 stimulant using or dependent participants was conducted to identify baseline clinical and demographic characteristics associated with differential response between participants in the exercise and health education control groups. Characteristics (i.e., moderators of treatment response) were identified using an established Best Approximating Modeling (BAM) method. Six moderators of treatment response were identified: Quick Inventory of Depressive Symptomatology – Clinician (QIDS-C) rated total score, exercise test maximum systolic blood pressure, number of lifetime drug treatments, Stimulant Craving Questionnaire (STCQ) total score, Addiction Severity Index (ASI) Family subscale score, and Cognitive and Physical Functioning Questionnaire (CPFQ) total score. For all moderators, the odds ratio of response to exercise vs. health education ranged from 0.32 to 2.52 or more depending on the level of the moderator.

Conclusions: These results demonstrate that it is possible to identify pre-treatment patient characteristics that predict statistically and clinically meaningful differential treatment response to exercise.

Related protocols: CTN-0037

Abstract:

Patient engagement may play a key role in the success or failure of treatments for substance use disorder (SUD). This exploratory analysis of data from a large, multisite effectiveness trial (CTN-0044) sought to determine how patient engagement with a digital therapeutic for SUD delivered at clinics was associated with abstinence outcomes.

The study evaluated engagement for 206 participants enrolled in a treatment program for SUDs related to cocaine, alcohol, cannabis, or other stimulants who were randomized to receive treatment as usual (TAU) or reduced TAU plus the digital Therapeutic Education System (TES) for 12 weeks. Participants were eligible for contingency management incentives for module completion (modules cover Community Reinforcement Approach topic areas) and negative urine drug screens. Analyses examined the association of module completion with end-of-treatment abstinence.

Participants completed a mean of 38.8 (range 0–72) TES modules over 12 weeks of treatment. Study completers (n = 157) completed a mean of 45.5 (range 9–72) TES modules, whereas study noncompleters (n = 49) completed a mean of 17.4 (range 0–45) TES modules. The study observed a strong positive correlation between TES engagement (i.e., total number of modules completed) and the probability of abstinence during weeks 9–12 of treatment among 157 study completers. Each module completed increased the odds of abstinence during weeks 9–12 by approximately 11% for study completers and 9% for the full sample. The study observed a similar, but weaker, association between engagement and abstinence among 49 patients who did not complete the study.

Conclusions: Greater engagement with a digital therapeutic for patients with SUD (i.e., number of modules completed over time) was strongly associated with the probability of abstinence in the last four weeks of treatment among those who completed the recommended 12-week treatment.

Related protocols: CTN-0044

Abstract:

The lack of a consensus on empirically supported and clinically meaningful outcome measures for stimulant use disorders (SUDs) continues to undermine the development and evaluation of effective behavioral and pharmacological treatment options. The aim of this study was to evaluate the clinical relevance of four stimulant use treatment outcome measures (longest curation of abstinence, percent of negative urinalysis submitted, abstinent in the last 2 weeks of treatment, and 3 or more weeks of continuous abstinence) by exploring their utility via association with stimulant and alcohol use, employment and legal problems, and severity of psychiatric symptomatology collected at follow-up.

Data used in these secondary analyses came from a multisite randomized contingency management treatment trial for SUDs (n=441) conducted through the NIDA Clinical Trials Network (CTN-0006). Multiple regression analyses were conducted to explore the association of 4 stimulant use treatment outcome measures and 8 3-month follow-up outcomes. Both dichotomous outcome measures showed similar performances being significantly associated with 4 follow-up outcomes. All outcome measures were consistently associated with better outcome responses at the 3-month follow-up, adding support to their clinical relevance and their adoption in SUD treatment trials. The two dichotomous outcome measures are reliable candidates to be used as endpoint outcomes, as recommended by the U.S. Food and Drug Administration (FDA).

Conclusions: The identification of clinically meaningful indicators of treatment response can promote important advances in the development of more effective treatments for stimulant use disorders (SUDs). These findings offer empirical support for the use of specific treatment outcome measures by determining their associations to clinically relevant 3-month follow-up outcomes.

Related protocols: CTN-0006

Abstract:

The aim of this study was to examine the impact of vigorous intensity, high dose exercise (DEI) on cannabis use among stimulant users compared to a health education intervention (HEI) using data from the Stimulant Reduction Intervention using Dosed Exercise NIDA Clinical Trials Network study (CTN-0037).

Adults (N=302) enrolled in the STRIDE randomized clinical trial were randomized to either the DEI or the HEI. Interventions included supervised sessions three times a week during the Acute phase (12 weeks) and once a week during the Follow-up phase (6 months). Cannabis use was measured at each assessment via Timeline Follow Back and urine drug screens. Cannabis use was compared between the groups during the Acute and Follow-up phases using both the intent-to-treat sample and a complier average causal effects (CACE) analysis.

Approximately 43% of the sample reported cannabis use at baseline. The difference in cannabis use between the DEI and HEI groups during the Acute phase was not significant. During the Follow-up phase, the days of cannabis use was significantly lower among those in the DEI group (1.20 days) compared to the HEI gruop (2.15 days; p=0.04).

Conclusions: Results suggest that there were no significant short-term differences in cannabis use between the two groups. However, there were long-term differences between participants in the DEI and HEI groups. Specifically, those who adhered to the exercise intervention, vigorous intensity, high-dose exercise resulted in less cannabis use at follow-up. Further study on the long-term impact of exercise as a treatment to reduce cannabis use should be considered.

Related protocols: CTN-0037

Abstract:

The natural course of prescription opioid use disorder has not been examined in longitudinal studies. This study examined correlates of opioid abstinence over time after completing a treatment trial for prescription opioid dependence.

The multi-site Prescription Opioid Addiction Treatment Study (POATS) examined different durations of buprenorphine-naloxone and different intensities of counseling to treat prescription opioid dependence. Following the clinical trial, a longitudinal study was conducted from March 2009-January 2013. At 18, 30, and 42 months after treatment entry, telephone interviews were conducted (N=375). In this exploratory, naturalistic study, logistic regression analyses examined the association between treatment modality (including formal treatment and mutual help (i.e., 12-step programs)) and opioid abstinence rates at the follow-up assessments.

At the three follow-up assessments, approximately half of the participants reported engaging in current substance use disorder treatment (47-50%). The most common treatments were buprenorphine maintenance (27-35%) and mutual-help group attendance (27-30%), followed by outpatient counseling (18-23%) and methadone maintenance (4%).

In adjusted analyses, current opioid agonist treatment showed the strongest association with current opioid abstinence (ORs=5.4, 4.6, and 2.8 at the three assessments), followed by current mutual-help attendance (ORs=2.2, 2.7, and 1.9); current outpatient counseling was not significantly associated with abstinence in the adjusted models.

Conclusions: This study, using long-term follow-up data from the largest randomized trial of treatment for prescription opioid dependence to date, found that ongoing treatment was strongly associated with odds of opioid abstinence up to 42 months following the trial. Although current opioid agonist treatment had the strongest association with abstinence, mutual-help attendance was also significantly associated with abstinence. Critically, mutual-help attendance was associated with an additive benefit among those receiving opioid agonist treatment and was also associated with abstinence in those not receiving agonist treatment. Adults with prescription opioid dependence appear to benefit from continued medication and mutual-help participation as part of long-term, ongoing care.

Related protocols: CTN-0030, CTN-0030-A-3

Abstract:

Substance use disorders are associated with lower cognitive functioning, and this impairment is associated with poorer outcomes. The Therapeutic Education System (TES) is an internet-based psychosocial intervention for substance use disorders that may provide enhanced treatment for individuals with cognitive deficits. This secondary analysis investigates the association between cognitive functioning and treatment outcomes in a large (N=507) randomized controlled effectiveness trial of TES compared to treatment-as-usual conducted within outpatient programs in the NIDA Clinical Trials Network (CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”).

Participants in the study completed a computer-based cognitive assessment (MicroCog (TM) short version) at baseline. Scores on subtests of attention, reasoning, and spatial perception were tested as moderators of the treatment effect on abstinence and retention at the end of the 12-week treatment phase using mixed effects logistic regression.

Cognitive functioning was not found to be a moderator of treatment on abstinence or retention. Post-hoc analysis of the main effect of cognitive functioning on retention and abstinence found impaired reasoning and cognitive flexibility were associated with lower retention. There were no other main effects of cognitive functioning on retention or abstinence.

Conclusions: The benefit of internet-delivered treatment over standard care was unchanged across a range of cognitive functioning. Consistent with previous research, mild to moderate impairment in reasoning and cognitive flexibility were associated with lower retention across both treatment arms. TES appears to be equally effective across a spectrum of cognitive functioning among diverse patients. Further study is needed to determine mechanisms by which cognitive functioning influences retention in treatment and to optimize technology-based interventions for those with cognitive impairment.

Related protocols: CTN-0044

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:

Emerging adults (roughly 18-29 years) with substance use disorders can benefit from participation in twelve-step mutual-help organizations (TSMHO), however, their attendance and participation in such groups is relatively low. Twelve-step facilitation therapies, such as the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), may increase attendance and involvement, and lead to decreased substance use.

This study used data from the NIDA Clinical Trials Network STAGE-12 protocol (CTN-0031), a multisite randomized controlled trial, to examine whether age moderated the STAGE-12 effects on substance use and TSMHO meeting attendance and participation, The original STAGE-12 study involved assessments at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3- and 6-months post-randomization; participants were adults with DSM-IV diagnosed stimulant abuse or dependence (N=450) enrolling in 10 intensive outpatient substance use treatment programs across the U.S. A zero-inflated negative binomial random-effects regression model was utilized to examine age-by-treatment interactions on substance use and meeting attendance and involvement.

Analyses found that younger age was associated with larger treatment effects for stimulant use. Specifically, younger age was associated with greater odds of remaining abstinent from stimulants in STAGE-12 versus Treatment-as-Usual; however, among those who were not abstinent during treatment, younger age was related to greater rates of stimulant use at follow-up for those in STAGE-12 compared to TAU. There was no main effect of age on stimulant use. Younger age was also related to somewhat greater active involvement in different types of TSMHO activities among those in STAGE-12 versus TAU. There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition.

Conclusions: These results suggest that STAGE-12 can be beneficial for some emerging adults with stimulant use disorder, and ongoing assessment of continued use is of particular importance. More targeted research addressing the differences between younger and older adults and their unique responses to treatment is needed, so that developmental variations can be considered in the provision of substance abuse treatment. Age-appropriate treatment could have considerable effects on clinical outcomes and public health.

Related protocols: CTN-0031