Pharmacogenetics of Disulfiram for Cocaine
Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence; Opioid Dependence
Intervention: Disulfiram (Drug); Methadone (Drug); CBT (Behavioral); Lactose (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s):
Thomas R. Kosten, MD, Principal Investigator, Affiliation: Baylor College of Medicine
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.
Clinical Details
Official title: Effectiveness of Disulfiram for Treating Cocaine Dependence in Individuals With Different Dopamine Beta Hydroxylase (DBH) Genes
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Urine Toxicology for Cocaine.
Secondary outcome: Retention by Treatment Condition.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
Michael E. DeBakey VA Medical Center, Houston, Texas 77030, United States
Additional Information
Starting date: January 2005
Last updated: November 27, 2012
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