Disulfiram for Cocaine Abuse in Buprenorphine Treatment
Information source: Yale University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence; Opioid Dependency
Intervention: Disulfiram (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s): Richard S. Schottenfeld, M.D., Principal Investigator, Affiliation: Yale University
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.
Clinical Details
Official title: Disulfiram for Cocaine Abuse in Buprenorphine Treatment
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cocaine abstinence
Secondary outcome: Opioid abstinence
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
The APT Foundation MRU, New Haven, Connecticut 06519, United States
Yale University School of Medicine, New Haven, Connecticut 06519, United States
Additional Information
Starting date: October 2000
Last updated: June 3, 2009
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