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.
The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by summing the item scores and ranges from 8 (lowest craving value) to 56 (highest craving value). Higher scores reflect greater craving (i.e. worse outcome).
- 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 (ASA).
Consistent with O'Malley et al. 2002, the ASA paradigm allows to use a fixed-dose (the priming drink), followed by a 2-hour "free-choice" phase when subjects may choose to drink or not up to 8 mini-drinks. Participants receive a monetary compensation of $3 dollars per each mini-drink not consumed; therefore the amount of minidrinks consumed during the 2-hour sessions ranges 0-8, and the monetary compensation ranges $0-24. The quantity of alcohol consumed during the free-choice session is expressed as "standard drinking unit", where a standard drink unit contains about 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons).
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076283
|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|