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This presentation reports on a National Drug Abuse Treatment Clinical Trials Network (CTN) study that aimed to evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence (CTN-0052). This randomized, double-blind, placebo-controlled, 16-week pilot trials was conducted at 6 clinical sites. Adults meeting DSM-IV-TR criteria for current cocaine dependence scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized, and planning to enroll in local outpatient treatment through the end of the active treatment phase, were randomized to buspirone titrated to 60 mg/day (n=35) or to placebo (n=27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days-to-first-cocaine-use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens.
Study retention was high, with a 94% completion rate, and medication adherence was also strong (85% based on medication events monitoring system). However, there were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. Additionally, buspirone, relative to placebo, actually increased the proportion of cocaine use days in female participants, though not in males.
Conclusions: These results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and may even worsen cocaine use outcomes for women.
Related protocols: CTN-0052
This is the primary outcomes article for CTN-0052.
The purpose of this study, “A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults with Cocaine Dependence (BRAC),” was to evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. This randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n=35) or placebo (n=27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n=23), there was a significant treatment-by-time interaction effect, reflecting an increase in cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n=39).
Conclusions: These results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may, in fact, worsen their cocaine use outcomes. The results from this pilot trial do not provide a strong rationale for conducting a larger follow-up trial as originally planned.
Related protocols: CTN-0052
Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Drug Abuse Treatment Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60mg/day) for cocaine relapse prevention. The study includes pilot (n=60) and full-scale (estimated n=264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS).
The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention. Having a greater understanding of these mediators could facilitate future medication development efforts for a condition with serious consequences and for which there is currently no widely used, safe and effective medication. Study recruitment for the pilot phase is scheduled to start in August 2012.
Related protocols: CTN-0052
The focus of this presentation is on the outcomes of medication studies in the CTN and how those outcomes can be applied to treatment in community-based settings. Medication studies in the CTN have included four studies on opioid dependence (buprenorphine vs. clonidine, buprenorphine taper, buprenorphine for adolescents, and the Prescription Opioid Addiction Treatment Study) and two studies on methylphenidate (methylphenidate for smokers with ADHD and methylphenidate for adolescents with ADHD and substance use disorder). Outcomes from each trial are presented, along with implications for community-based treatment providers. Overall, these protocols have demonstrated that medication studies — both straight-forward studies and highly complex ones — can be conducted safely and effectively in community drug abuse treatment programs. Staff members in these programs can be highly enthusiastic about the new therapies, something that aids in implementation, and evidence supports the fact that successful medication trials can lead to increased use of empirically validated pharmacotherapies.
The presentation ends with a look at ongoing and future medication research in the CTN, including buprenorphine for cocaine dependence, long-acting injectable naltrexone for opioid dependence, bupropion for smokers with stimulant dependence, buspirone for cocaine dependence, and treatments for cannabis dependence.
Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0009, CTN-0010, CTN-0028, CTN-0030