Improving Learning-based Treatment of Cocaine Dependence With Medication
This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Improving Learning-based Treatment of Cocaine Dependence With Medication|
- Urinalysis benzoylecgonine (cocaine metabolite)(ng/ml) [ Time Frame: 1 month post-treatment ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: Yes ]self-report of medication side effects
- Battery of Learning/Cognitive Assessments [ Time Frame: At the baseline laboratory visit ] [ Designated as safety issue: No ]Battery of Learning/Cognitive Assessments will be used to assess learning, extinction, reversal learninging, and memory during the baseline laboratory session.
|Study Start Date:||September 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: 50 mg d-cycloserine
active drug condition
50 mg d-cycloserine
Placebo Comparator: Sugar pill
Drug: sugar pill
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 battery of learning/cognitive tasks will test for forms of learning/cognition enhanced by DCS that might contribute to the treatment effect. This project will test the efficacy of a novel intervention for cocaine dependence that was developed based on a known efficacious cocaine dependence treatment (CM), principles of extinction learning theory, and a medication shown to improve preclinical learning in general, including extinction of cocaine conditioning, and clinical learning-based exposure treatment of anxiety disorders. The study may indicate cost effective additions (home exposure sessions and DCS) to extend CM benefit after the removal of contingencies, and therefore may increase the dissemination of CM in community settings.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526538
|United States, Maryland|
|Behavioral Pharmacology Research Unit|
|Baltimore, Maryland, United States, 212124|