NCT00580827

Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cocaine-Related Disorder
• Opiate Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-09-01
• Primary completion: 2004-03-01
• First posted: 2007-12-27
• Last updated: 2020-03-31

Locations

1 site across 1 country: United States