At a glance
ClinicalIndex Comparison Record- ✓Meets DSM-IV criteria for primary alcohol dependence with loss of control of drinking
- ✓Able to maintain sobriety for at least 4 days, with or without detoxification medications
- ✓No more than one previous inpatient medical detoxification episode
- ✓Consumes on average ≥5 standard drinks daily for men, ≥4 for women
- ✕Currently meets DSM-IV criteria for any other psychoactive substance dependency except nicotine
- ✕History of opioid abuse at any time
- ✕Any psychoactive substance abuse (except marijuana and nicotine) in the past 30 days
- ✕Current DSM-IV Axis I psychiatric disorders including major depression, panic, OCD, PTSD, bipolar disorder, dissociative disorder, eating disorder, schizophrenia, or other psychotic/organic mental disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Gabapentin as an Adjunct to Naltrexone for Alcoholism
In Brief
A Phase 3 clinical trial evaluating Naltrexone, Naltrexone plus Gabapentin, and 1 other intervention for Alcohol Dependence. Completed, enrolled 150 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo. All participants will receive alcohol counseling.
Study Details
Timeline
Interventions
Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks
naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks
Placebo