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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Yale University University of Arkansas University of Texas |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00149630 |
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.
Condition | Intervention | Phase |
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Cocaine Dependence Opioid Dependency |
Drug: Disulfiram Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effectiveness of Disulfiram for Treating Cocaine Dependence in Individuals With Different Dopamine Beta Hydroxylase (DBH) Genes |
Estimated Enrollment: | 200 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Disulfiram
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Drug: Disulfiram
250 mg/day
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo daily dosing
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Dopamine, a type of neurotransmitter, is the brain's "feel good" chemical. The amount of dopamine in the body may be an important factor in how cocaine addicts respond to treatment. Disulfiram, like cocaine, enhances dopamine activity. Upon taking disulfiram, subsequent intake of cocaine may elevate dopamine to excessive levels that produce extreme discomfort. DBH is an enzyme that breaks down dopamine. A particular variation in the DBH gene can affect the amount of dopamine that is released in the body. Therefore, cocaine addicts with varying DBH genes may respond differently to treatment. The purpose of this study is to compare the effectiveness of disulfiram in preventing relapse among methadone-maintained individuals addicted to both cocaine and opioids who may have different DBH genes.
This 17-week study will begin with a 2-week methadone stabilization period. Participants will then be randomly assigned to receive a daily dose of either 250 mg of disulfiram or placebo for 12 weeks, while concurrently receiving methadone treatment. All participants will stop receiving study medication at Week 14, at which point they will undergo a 4-week methadone detoxification period. Participants will report cocaine and other drug use, as well as any cocaine cravings that they experience. Cocaine levels will be monitored throughout the study with urine tests. The DBH gene of each participant will be examined to determine its specific make-up and any particular variations.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Tiffany L. Polk, MBA/HCM | 832-689-1769 | tiffanyp@bcm.edu |
Contact: Grace Wu, MD | 713-791-1414 ext 6384 | ggwu@bcm.edu |
United States, Texas | |
Michael E. DeBakey VA Medical Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Thomas Kosten, MD 713-794-7032 kosten@bcm.edu | |
Contact: Tiffany L. Polk, MBA/HCM 832-689-1769 tiffanyp@bcm.edu |
Principal Investigator: | Thomas R. Kosten, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Thomas Kosten, MD ) |
Study ID Numbers: | NIDA-18197-2, P50-18197-2, DPMC |
Study First Received: | September 6, 2005 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00149630 |
Health Authority: | United States: Federal Government |
Opioid Dependency Substance Related Disorders |
Disulfiram Cocaine-Related Disorders Dopamine Mental Disorders |
Substance-Related Disorders Disorders of Environmental Origin Cocaine Ethanol |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Central Nervous System Agents Pharmacologic Actions Alcohol Deterrents |