Pharmacogenetics of Disulfiram for Cocaine
NCT00149630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93
Last updated 2017-03-15
Summary
Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
Conditions
- Cocaine Dependence
- Opioid Dependence
Interventions
- DRUG
-
Disulfiram
Disulfiram 250 mg/day by mouth daily during study weeks 2-13. Disulfiram discontinued during study weeks 14-15.
- DRUG
-
Methadone
Initial dose 25 mg; increased by 5 mg at each subsequent daily dosing until 60 mg maintenace dose reached.
- BEHAVIORAL
-
CBT
1-hour weekly, individual, manual-guided Cognitive Behaviorial Therapy.
- OTHER
-
Lactose
Lactose was added to both the active disulfiram and placebo doses so they tasted identical.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Yale University
collaborator OTHER -
Baylor College of Medicine
lead OTHER
Principal Investigators
-
Thomas R. Kosten, MD · Baylor College of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2009-12-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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