Alcoholism Clinical Trial
Official title:
Two Medications, Disulfiram and Naltrexone, in the Treatment of Patients With Both Cocaine and Alcohol Dependence
Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond poorly to existing treatments and have received little research attention in the past. The purpose of this study is to determine whether the combination of naltrexone and disulfiram is useful in decreasing alcohol use and cravings in people diagnosed with both cocaine and alcohol dependence.
Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond
poorly to existing treatments and have received little research attention in the past.
Naltrexone and disulfiram are medications currently approved for treating alcohol
dependence. These two medications have different mechanisms of action in the body. In
combination they might be effective in treating individuals dually diagnosed with cocaine
and alcohol dependence. The purpose of this study is to determine whether the combination of
naltrexone and disulfiram is useful in decreasing alcohol cravings in individuals who are
dependent on both cocaine and alcohol.
Participants in this 5-year, double-blind study will be randomly assigned to receive
disulfiram, naltrexone, both, or placebo. Treatment will occur for a 3-month period, after
which alcohol, cocaine use, and other biopsychosocial measures will be assessed at Months 6
and 9.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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