19 research outputs found
A multi-site, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence
Objective—To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.
Method—A randomized, double-blind, placebo-controlled, 16-week pilot trial conducted at six clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IVTR 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.
Results—There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the females (n=23), there was a significant treatment-bytime interaction effect (X2 (1)=6.06, p=.01), reflecting an increase in cocaine use by the buspirone, relative to placebo, participants early in the outpatient treatment phase. A similar effect was not detected in the male participants (n=39; X2 (1)=0.14, p=.70).
Conclusions—The 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 worsen their cocaine-use outcomes.
Trial Registration—Clinical Trials.gov http://www.clinicaltrials.gov; Identifier: NCT0164115
Motivational enhancement therapy to improve treatment utilization and outcome in pregnant substance users
Pregnant substance users can benefit significantly from substance abuse treatment but treatment retention can be challenging. Two hundred pregnant substance users entering outpatient substance abuse treatment at 1 of 4 treatment programs were randomized to receive either 3 individual sessions of Motivational Enhancement Therapy for pregnant substance users (MET-PS) or the first 3 individual sessions normally provided by the program. All participants were encouraged to participate in all other treatment offered by the program. Outcome measures included treatment utilization according to clinic records, qualitative urine toxicology measures, and self-report of substance use. One hundred and sixty two participants (i.e., 81%) completed the 1 month active phase. Participants attended 62% of scheduled treatment on average and reported decreased substance use during the first month of treatment, with no differences between MET-PS and treatment as usual participants. There was some evidence that the efficacy of MET-PS varied between sites and that MET-PS might be more beneficial than TAU in decreasing substance use in minority participants. These results suggest that MET-PS is not more effective than treatment as usual for pregnant substance users in general but that there might be particular subgroups or treatment programs for which MET-PS might be more or less effective than treatment as usual
The association of program-related variables to length of sobriety: A pilot study of chemically dependent women
CLIENT AND PROVIDER VIEWS ON ACCESS TO CARE FOR SUBSTANCE-USING AMERICAN INDIANS: PERSPECTIVES FROM A NORTHERN PLAINS URBAN CLINIC
A method to diagnose opioid dependence resulting from heroin versus prescription opioids using the Composite International Diagnostic Interview
Multisite, Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial to Evaluate the Efficacy of Buspirone as a Relapse-Prevention Treatment for Cocaine Dependence
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Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.
Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population