Disulfiram for Cocaine Abuse in Buprenorphine Treatment
NCT ID: NCT00913484
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
177 participants
INTERVENTIONAL
2000-10-31
2004-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Disulfiram
Disulfiram 250 mg per day
Disulfiram
Disulfiram 250 mg per day
Placebo
Placebo
Placebo
Placebo daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Disulfiram
Disulfiram 250 mg per day
Placebo
Placebo daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard S. Schottenfeld, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The APT Foundation MRU
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.