The purpose of this study is to learn whether ondansetron is safe and effective in the treatment of alcohol dependence. We also want to learn whether the study drug ondansetron combined with Cognitive Behavioral Therapy will assist researchers to determine whether having a certain gene is responsible for determining how a person benefits or does not benefit from the use of ondansetron for alcohol dependence.
This is a 13 week outpatient clinical trial. Participants will either receive ondansetron or placebo and behavioral therapy. There is a 1, 2, and 3 month post-study follow up visit.Screening for this study is initially done over the telephone and takes 15-20 minutes. If participants are eligible after the initial screen, they will be invited to come in for a more thorough in house screen which takes about 5 to 6 hours. The screening will include a physical exam, review of medical, alcohol and drug histories and blood collection. If participants are found to be eligible after the in house screen, they will be enrolled in the 13 week outpatient clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
283
13 week outpatient trial
13 week outpatient trial
UVA Center for Addiction Research and Education
Charlottesville, Virginia, United States
Self-reported measure of alcohol consumption (Drinks per Day, Drinks per Drinking Day, Percent Days Abstinent), CDT (ondansetron level), GGT, BAC
Time frame: Throughout the study
Pill count, CIWA-Ar, OCDS, Age of onset, SFQ, AASE, ADBS, CGI, TCI, MAC, attendace at psychosocial services
medication compliance, withdrawal, alcohol craving, social functioning and motivation
Time frame: Throughout the study
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