Pharmacogenetics of Disulfiram for Cocaine
Disulfiram
Effectiveness of Disulfiram for Treating Cocaine Dependence in Individuals With Different Dopamine Beta Hydroxylase (DBH) Genes
2 other identifiers
interventional
93
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
December 28, 2012
CompletedMarch 15, 2017
February 1, 2017
4.9 years
September 6, 2005
October 22, 2012
February 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urine Toxicology for Cocaine.
Thrice weekly, baseline through week 14.
Secondary Outcomes (1)
Retention by Treatment Condition.
12 weeks
Study Arms (2)
Disulfiram, Methadone (w/lactose) & CBT
EXPERIMENTALParticipants are randomly assigned to receive a daily dose of 250 mg of disulfiram 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.
Placebo, Methadone (w/lactose) & CBT
ACTIVE COMPARATORParticipants are randomly assigned to receive a daily dose of a sugar pill to mimic the experimental drug disulfiram for 12 weeks, while concurrently receiving methadone treatment. All participants will stop receiving all medication at week 14, at which point they will undergo a 4-week methadone detoxification period.
Interventions
Disulfiram 250 mg/day by mouth daily during study weeks 2-13. Disulfiram discontinued during study weeks 14-15.
Initial dose 25 mg; increased by 5 mg at each subsequent daily dosing until 60 mg maintenace dose reached.
1-hour weekly, individual, manual-guided Cognitive Behaviorial Therapy.
Lactose was added to both the active disulfiram and placebo doses so they tasted identical.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- National Institute on Drug Abuse (NIDA)collaborator
- Yale Universitycollaborator
Study Sites (1)
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
Related Publications (2)
Thomas PS Jr, Nielsen EM, Spellicy CJ, Harding MJ, Ye A, Patriquin M, Hamon SC, Kosten TR, Nielsen DA. The OPRD1 rs678849 variant influences outcome of disulfiram treatment for cocaine dependency in methadone-maintained patients. Psychiatr Genet. 2021 Jun 1;31(3):88-94. doi: 10.1097/YPG.0000000000000279.
PMID: 33953123DERIVEDSpellicy CJ, Kosten TR, Hamon SC, Harding MJ, Nielsen DA. The MTHFR C677T Variant is Associated with Responsiveness to Disulfiram Treatment for Cocaine Dependency. Front Psychiatry. 2013 Jan 14;3:109. doi: 10.3389/fpsyt.2012.00109. eCollection 2012.
PMID: 23335901DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sample size is small for this genetic association study, and larger replications of this preliminary study are needed. Most cocaine abusers are not also opioid dependent, which limits generalization of findings.
Results Point of Contact
- Title
- Thomas R. Kosten, M.D.
- Organization
- Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas R. Kosten, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
January 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 15, 2017
Results First Posted
December 28, 2012
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share