Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366626
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2006-08-17
Brief Title:
Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Alcohol Research Center Grant Component 1 Naltrexone Effects on Alcohol Reactivity and Consumption Evaluating the Genetic Variability of Naltrexone Response
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 mgday 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 educationalmotivational counseling regarding their alcohol use and its effects Referral for treatment will be offered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None