A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
This pilot trial has the goal to demonstrate the feasibility of a study to test the effects of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration paradigms in non-treatment seeking alcohol-dependent subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Pilot Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking|
- alcohol urge [ Time Frame: approximately 8 days after drug administration ] [ Designated as safety issue: No ]Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Urge Questionnaire (AUQ)] during the Cue Reactivity.
- alcohol drinking [ Time Frame: approximately 8 days after drug administration ] [ Designated as safety issue: Yes ]Whether baclofen, as compared to active placebo, results in lower quantity of alcohol consumed during the Alcohol Self-Administration.
|Study Start Date:||December 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Baclofen
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
Baclofen 10mg t.i.d.
Placebo Comparator: Cyproheptadine
Cyproheptadine 2 mg t.i.d. for 8-10 days
|United States, Rhode Island|
|Brown University Center for Alcohol and Addiction Studies|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Lorenzo Leggio, M.D., M.Sc.||Brown University Center for Alcohol and Addiction Studies|