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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
Matched placebo.
disulfiram at 62.5 mg/day for 12 weeks.
Disulfiram at 125 mg/day for 12 weeks.
disulfiram at 250 mg/day for 12 weeks.
West Haven VA
West Haven, Connecticut, United States
Reductions in cocaine use as measured by urine toxicology and self-report
Time frame: 14 weeks
Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested.
Time frame: 14 weeks
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