Pharmacogenetics of Disulfiram for Cocaine

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine Dependence, Opioid Dependence

In brief

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.

Key facts

Study ID

NCT00149630

Run by

Baylor College of Medicine

People needed

93

Starts

2005-01-01

Expected to finish

2009-12-01

Last updated by the study team

2017-03-15

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Michael E. DeBakey VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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