Official Title: “Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers”

This 18-week, randomized, double blind clinical trial provided treatment for 160 cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM maintenance during the first 4 weeks and cocaine use was assessed; participants were then stratified by level of cocaine use and randomly assigned to receive one of the following:

placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or disulfiram at 250 mg/day. During induction onto LAAM, participants were administered increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus disulfiram or placebo disulfiram according to their randomized assignments, and were maintained on these agents through week 16. At the end of the study, participants underwent detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who received ongoing supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes included reductions in other illicit drug and alcohol use, as well as improvements in psychosocial functioning.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: March 2004

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Matched placebo.
• Drug: Disulfiram
  • disulfiram at 62.5 mg/day for 12 weeks.
• Drug: Disulfiram
  • Disulfiram at 125 mg/day for 12 weeks.
• Drug: Disulfiram
  • disulfiram at 250 mg/day for 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: placebo disulfiram
  • placebo disulfiram (0 mg/day)
• Experimental: disulfiram 62.5
  • disulfiram at 62.5 mg/day
• Experimental: disulfiram 125
  • disulfiram at 125 mg/day
• Experimental: disulfiram 250
  • disulfiram at 250 mg/day

Primary Measures

• Reductions in cocaine use as measured by urine toxicology and self-report
  • Time Frame: 14 weeks
    Safety Issue?: No

Secondary Measures

• Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested.
  • Time Frame: 14 weeks
    Safety Issue?: No

Inclusion Criteria:

• Between the ages of 18-65 years.
• Are not currently enrolled in treatment.
• Participants must demonstrate opioid dependence, as evidenced by documentation of prior opioid agonist maintenance and/or have signs of withdrawal upon administration of naloxone (<0.8 mg, i.m.), and an opioid-positive urine screen.
• Participants also must be current users of cocaine with self-reported use of > 7 gm during the preceding 12 months, self-reported use of > 1 time/week in at least one month preceding study entry, and cocaine-positive urine screen.
• Participants must fulfill DSM-IV criteria for opioid and cocaine dependence.

Exclusion Criteria:

• current diagnosis of other drug or alcohol physical dependence (other than opiates, cocaine or tobacco)
• significant medical conditions such as abnormal liver function (with laboratory findings greater than three times normal).
• active hepatitis; hypertension; a current cardiac condition or high risk of cardiovascular disease; seizure disorders; or another significant underlying medical condition which would contraindicate disulfiram or LAAM treatment.
• meets DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders; exhibiting current suicidality or homicidality; current use of a prescribed psychotropic medication that cannot be discontinued.
• pregnancy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

James Poling, Ph.D. Principal Investigator Yale University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580827

Study ID Number: R01 DA13441

ClinicalTrials.gov Identifier: NCT00580827

Health Authority: United States: Institutional Review Board