Clinical Trial: Improving Learning-based Treatment of Cocaine Dependence With Medication

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Improving Learning-based Treatment of Cocaine Dependence With Medication

Brief Summary: This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.

Detailed Summary: Cocaine dependence is a public health problem with substantial morbidity, however no effective pharmacotherapy for cocaine dependence has been approved by the FDA. Unlike previous medication studies that have sought to pharmacologically reduce cocaine reinforcement, seeking or craving, this exploratory clinical trial will test d-cycloserine (DCS) for its ability to improve learning-based behavioral treatment of cocaine dependence. DCS is an NMDA partial agonist that has been shown to robustly improve learning in preclinical models, including extinction of cocaine conditioned place preference and blockade of cocaine reacquisition, and to improve extinction-learning based exposure therapy for multiple anxiety disorders. This Phase II clinical trial will investigate the pharmacological (DCS) enhancement of a behavioral treatment combining contingency management (CM) and novel home-environment exposure therapy sessions for cocaine dependence. High magnitude CM incentives will be used to promote the cocaine abstinence necessary for extinction in home-based exposure sessions. Participants will be randomized into 2 groups: 1. CM with placebo (CM+PL), and 2. CM with DCS (CM+DCS). For 19 days after group assignment, participants will report to the laboratory 3 times per week (Mon, Wed, Fri) to provide urine samples, receive contingent vouchers, and complete assessments of drug use, craving, mood, withdrawal, and quit self-efficacy. DCS (50 mg) or placebo will be administered on Mon, Wed and Fri study visits (at the end of the lab visit before returning to the home environment for exposure sessions during the time of DCS action). Follow-up visits will be conducted at 1 week, 1 month, and 3 months post-CM completion, during which time measures of drug use (self-reported and urinalysis), craving, mood, and withdrawal will be obtained. Comparison of continuous abstinence post-CM between the groups will be the primary outcome measure. During an initial laboratory session, a batte
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml) [ Time Frame: 1 month post-treatment ]
    The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results
  • Medication Side-effects [ Time Frame: 1 month post-treatment. ]
    self-report of medication side effects (Units of Measure is the count of specific reported effects)


Original Primary Outcome:

  • Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml) [ Time Frame: 1 month post-treatment ]
    The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results
  • Medication side-effects (Units of Measure is the count of specific reported effects) [ Time Frame: 1 month post-treatment. ]
    self-report of medication side effects


Current Secondary Outcome: Learning Task by Itami and Uno [ Time Frame: At the baseline laboratory visit ]

Original Secondary Outcome: Battery of Learning/Cognitive Assessments [ Time Frame: At the baseline laboratory visit ]

Battery of Learning/Cognitive Assessments will be used to assess learning, extinction, reversal learninging, and memory during the baseline laboratory session.


Information By: Johns Hopkins University

Dates:
Date Received: January 30, 2012
Date Started: September 2011
Date Completion:
Last Updated: December 22, 2016
Last Verified: December 2016