Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.
The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) is more effective in the reduction of alcohol craving and drinking compared to placebo in individuals with particular genetic predisposition.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Alcohol Research Center Grant. Component #1: Naltrexone Effects on Alcohol Reactivity and Consumption, Evaluating the Genetic Variability of Naltrexone Response|
- "Natural" Alcohol Consumption Period; Average Number of Drinks Per Day Consumed During the 5 Day Natural (Usual Environment) Drinking Observation Period [ Time Frame: treatment days 1 - 5 ] [ Designated as safety issue: No ]
- Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed [ Time Frame: On day 7 of treatment during limited access alcohol consuption in the bar/laboratory ] [ Designated as safety issue: No ]Subjects were allowed to drink up to 8 alcohol drinks during 2 hours observation period being in bar/laboratory settings vs to get $2 per each not consumed drink.
|Study Start Date:||April 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Naltrexone one capsule a day
Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7)
Other Name: ReVia
Placebo Comparator: 2
One capsule a day match to naltrexone
Placebo for 7 days matched to Naltrexone
About 300 non-treatment seeking alcoholics will be recruited through advertisement and paid for their participation. They will be assessed, subtyped for mu-opiate receptor and catechol-O-methyltransferase (COMT) allelic variants and 88 individuals (44 with the more common AA gene and 44 with either an AG or GG gene) will be randomly assigned to take either naltrexone (50 mg/day) or a matching placebo for 7 days. Since the val and met alleles of the catechol-O-methyltransferase (COMT) gene are each present in about 50% of the population they will be equally distributed by urn randomization to all opiate allele and treatment groups. After 5 days of natural drinking and one day of abstinence, subjects will undergo an alcohol cue-induced brain activity scan using well-established fMRI techniques on Day 6 of study drug. The following day all subjects will receive a standard dose (gender and weight corrected) of alcohol and be evaluated for alcohol reactivity (stimulation, sedation, intoxication, craving) over 40 minutes. They then will be allowed to consume up to 8 mini-drinks over a 2-hour period. Afterwards all subjects will receive educational/motivational counseling regarding their alcohol use and its effects. Referral for treatment will be offered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366626
|United States, South Carolina|
|· Center for Drug and Alcohol Programs,· Medical University of South Carolina|
|Charleston,, South Carolina, United States, 29425|
|Principal Investigator:||Raymond F Anton, MD||Medical University of South Carolina|