At a glance
ClinicalIndex Comparison Record- ✓Age 18 or older
- ✓DSM-IV diagnosis of current cocaine and alcohol dependence by SCID-IV
- ✓In past 30 days, used ≥$200-worth of cocaine
- ✓Heavy alcohol use: minimum 48 drinks (avg 12/week) in consecutive 30-day period within prior 90 days, with ≥2 days of heavy drinking (5+ drinks/day males; 4+ drinks/day females)
- ✕Abstinent from cocaine or alcohol for 30 consecutive days before consent
- ✕DSM-IV dependence on any substance other than cocaine and alcohol (except nicotine)
- ✕Any psychoactive medications including anti-seizure drugs (except diphenhydramine for sleep as needed)
- ✕Current or lifetime schizophrenia, psychotic disorder, organic mental disorder, or other clinically significant psychiatric disorder interfering with study participation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Double-blind, Placebo-Controlled, Pilot Trial of the Combination of Modafinil and Naltrexone for the Treatment of Cocaine and Alcohol Dependence
In Brief
A Phase 2 clinical trial evaluating Naltrexone, Modafinil, and 1 other intervention for Alcohol-Related Disorders and 2 related conditions. Completed, enrolled 164 participants across 1 site.
Detailed Summary
Modafinil is a medication that may enhance mood and increase energy in cocaine addicts, which may be useful in preventing cocaine relapse. Naltrexone is a medication that is currently used to treat drug and alcohol addiction. A combination of these two medications may be beneficial in reducing drug and alcohol use in individuals undergoing substance abuse treatment. The purpose of this study is to evaluate the effectiveness of modafinil and naltrexone, alone and in combination, at reducing drug and alcohol use in individuals addicted to cocaine and alcohol.
Study Details
Timeline
Interventions
150 mg daily for males; 100 mg daily for females
400 mg daily
400 mg and/or 100-150 mg placebo pills