Working… Menu

Disulfiram for Cocaine Abuse in Buprenorphine Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00913484
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : November 19, 2020
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Opioid Dependency Drug: Disulfiram Drug: Placebo Phase 2

Detailed Description:

The Specific Aims and hypotheses for the proposed study are as follows:

  1. To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is that disulfiram is superior to placebo.
  2. To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high, intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is higher in subjects with low DBH compared to subjects with high DBH.
  3. To explore whether baseline measures of alcohol use predict response to disulfiram. Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of the severity of baseline alcohol use.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disulfiram for Cocaine Abuse in Buprenorphine Treatment
Study Start Date : October 2000
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Disulfiram
Disulfiram 250 mg per day
Drug: Disulfiram
Disulfiram 250 mg per day

Placebo Comparator: Placebo
Drug: Placebo
Placebo daily

Primary Outcome Measures :
  1. Cocaine abstinence [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Opioid abstinence [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • English speaking adults ages 18 - 45.
  • Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing.
  • Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study.

Exclusion Criteria:

  • Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction.
  • Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol.
  • Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT > 3X normal) will also be excluded.
  • Presence of any of the following cardiovascular risk factors:

    • age > 45 years
    • history of cocaine-related chest pain
    • systolic blood pressure > 140 or diastolic blood pressure > 90
    • evidence of ischemia or past myocardial infarction on EKG
    • significant family history of risk (first degree relative with myocardial infarction prior to age 60)
    • elevated cholesterol (> 300 mg/dl), elevated LDL (> 170 mg/dl) or low HDL (< 20 mg/dl)
  • Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study.
  • Current suicide or homicide risk or current psychotic disorder.
  • Inability to read or understand the symptom checklists.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00913484

Layout table for location information
United States, Connecticut
The APT Foundation MRU
New Haven, Connecticut, United States, 06519
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Layout table for investigator information
Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
Layout table for additonal information
Responsible Party: Yale University Identifier: NCT00913484    
Other Study ID Numbers: 1R01DA012979 ( U.S. NIH Grant/Contract )
1R01DA012979 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Keywords provided by Yale University:
Cocaine dependence
Opioid dependence
Additional relevant MeSH terms:
Layout table for MeSH terms
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action