Naltrexone Effects on Alcohol Intake
The purpose of this study is to examine drinking behavior and decision-making while taking Naltrexone and placebo. This is a double-blind, randomized, placebo-controlled crossover study. There are two cycles: one cycle on Naltrexone and one cycle on placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Naltrexone Effects on Alcohol Intake Using a Laboratory Bar in Asp40 Positive and Negative Alcohol Users Characterized by fMRI and Genetic Screening|
|Study Start Date:||February 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
The study proposed is a 22 to 23 day, double-blind, placebo-controlled crossover study in 60 male and female moderate to heavy alcohol users who are Asp40 positive and negative. Subjects will undergo a 6 to 7-day cycle taking the first study drug (naltrexone or placebo) with an alcohol self-administration visit in the laboratory bar on the 6th or 7th day of drug. The first alcohol self-administration visit is followed by an 8 to 9 day washout period. Subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). On the final day (either day 8 or 9) of the first study drug cycle, the subject will undergo functional imaging (fMRI) at the WBIC. There will be at least one day in between the 'lab bar' and the fMRI scan. The first fMRI visit is followed by a 5-6 day washout period. Subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). Subjects will keep daily diaries of alcohol and medication use throughout the study.
|United States, California|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Michael C Rowbotham, MD||University of California, San Francisco|