Disulfiram for Cocaine Abuse in Buprenorphine Treatment

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine Dependence, Opioid Dependency

In brief

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.

Key facts

Study ID

NCT00913484

Run by

Yale University

People needed

177

Starts

2000-10-01

Expected to finish

2004-02-01

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The APT Foundation MRU — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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