Pharmacogenetics of Disulfiram for Cocaine - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2005

Last Updated Date

March 3, 2009

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

Self reports of cocaine and other drug use and cravings; measured throughout the study [ Time Frame: measured throughout the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Urine toxicology for cocaine

Change History

Complete list of historical versions of study NCT00149630 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Pharmacogenetics of Disulfiram for Cocaine

Official Title ^†

Effectiveness of Disulfiram for Treating Cocaine Dependence in Individuals With Different Dopamine Beta Hydroxylase (DBH) Genes

Brief 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.

Detailed Description

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Cocaine Dependence
Opioid Dependency

Intervention ^†

Drug: Disulfiram
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Disulfiram
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

200

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Meets DSM-IV diagnosis criteria for opioid dependence, as determined by documentation of prior treatment for addiction; signs of withdrawal; self-reported history of dependence for at least 1 year; and a positive urine test for opioids
Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the Severity Dependence Scale
If female, willing to use contraception throughout the study

Exclusion criteria:

Meets DSM-IV diagnosis criteria for dependence on any drugs other than opiates, cocaine, or tobacco
Current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder
Current suicidal or homicidal ideation
Current use of a prescribed psychotropic medication that cannot be discontinued
History of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater than normal); or high blood pressure
High risk factor for heart disease, seizure disorders, or any illness for which disulfiram or methadone treatment would be inadvisable
Currently taking metronidazole or clotrimazole
Pregnant or breastfeeding

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Tiffany L. Polk, MBA/HCM	832-689-1769	tiffanyp@bcm.edu
Contact: Grace Wu, MD	713-791-1414 ext 6384	ggwu@bcm.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00149630

Responsible Party

Thomas Kosten, MD, Baylor College of Medicine

Secondary IDs ^††

P50-DA18197-02, DPMC

Study Sponsor ^†

National Institute on Drug Abuse (NIDA)

Collaborators ^††

Yale University
University of Arkansas
University of Texas

Investigators ^†

Principal Investigator:

Thomas R. Kosten, MD

Baylor College of Medicine

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.