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Sponsors and Collaborators: |
Yale University National Institute on Drug Abuse (NIDA) |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00580827 |
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.
Condition | Intervention |
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Cocaine-Related Disorder Opiate Dependence |
Drug: Placebo Drug: Disulfiram |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers |
Enrollment: | 126 |
Study Start Date: | September 2003 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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placebo disulfiram: Placebo Comparator
placebo disulfiram (0 mg/day)
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Drug: Placebo
Matched placebo.
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disulfiram 62.5: Experimental
disulfiram at 62.5 mg/day
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Drug: Disulfiram
disulfiram at 62.5 mg/day for 12 weeks.
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disulfiram 125: Experimental
disulfiram at 125 mg/day
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Drug: Disulfiram
Disulfiram at 125 mg/day for 12 weeks.
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disulfiram 250: Experimental
disulfiram at 250 mg/day
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Drug: Disulfiram
disulfiram at 250 mg/day for 12 weeks.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Yale University ( James Poling, Ph.D. / Research Scientist ) |
Study ID Numbers: | R01 DA13441, NIDA R01 DA13441 |
Study First Received: | December 25, 2007 |
Last Updated: | December 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00580827 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Disulfiram Cocaine-Related Disorders Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Cocaine Opioid-Related Disorders Ethanol |
Disulfiram Cocaine-Related Disorders Molecular Mechanisms of Pharmacological Action Mental Disorders Therapeutic Uses Substance-Related Disorders |
Disorders of Environmental Origin Enzyme Inhibitors Opioid-Related Disorders Central Nervous System Agents Pharmacologic Actions Alcohol Deterrents |