Official Title: “Effectiveness of Disulfiram for Treating Cocaine Dependence in Individuals With Different Dopamine Beta Hydroxylase (DBH) Genes”

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.

Study Type: Interventional

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

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Disulfiram
  • 250 mg/day
• Drug: Placebo
  • Placebo daily dosing

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Disulfiram
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Self reports of cocaine and other drug use and cravings; measured throughout the study
  • Time Frame: measured throughout the study
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Thomas R. Kosten, MD Principal Investigator Baylor College of Medicine  

Overall Contact: Tiffany L. Polk, MBA/HCM 832-689-1769 tiffanyp@bcm.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00149630

Study ID Number: NIDA-18197-2

ClinicalTrials.gov Identifier: NCT00149630

Health Authority: United States: Federal Government