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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7)
Placebo for 7 days matched to Naltrexone
· Center for Drug and Alcohol Programs,· Medical University of South Carolina
Charleston, South Carolina, United States
"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
Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed
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.
Time frame: On day 7 of treatment during limited access alcohol consuption in the bar/laboratory
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