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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

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date November 19, 2020
Study Start Date  ICMJE October 2000
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Cocaine abstinence [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Opioid abstinence [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Disulfiram for Cocaine Abuse in Buprenorphine Treatment
Official Title  ICMJE Disulfiram for Cocaine Abuse in Buprenorphine Treatment
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cocaine Dependence
  • Opioid Dependency
Intervention  ICMJE
  • Drug: Disulfiram
    Disulfiram 250 mg per day
  • Drug: Placebo
    Placebo daily
Study Arms  ICMJE
  • Experimental: Disulfiram
    Disulfiram 250 mg per day
    Intervention: Drug: Disulfiram
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00913484
Other Study ID Numbers  ICMJE 1R01DA012979( U.S. NIH Grant/Contract )
1R01DA012979 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
PRS Account Yale University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP