Pharmacogenetics of Disulfiram for Cocaine

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborators: National Institute on Drug Abuse (NIDA); Yale University
• Treatments: Cocaine; Disulfiram; Methadone

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);

• 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