A Pilot Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
Overview
- Phase
- Phase 2
- Intervention
- Baclofen
- Conditions
- Alcoholism
- Sponsor
- Brown University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Alcohol Urge
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Lorenzo Leggio
Assistant Professor (Research)
Brown University
Eligibility Criteria
Inclusion Criteria
- •must be male or female between 21 and 65 years old (inclusive).
- •participants must meet criteria for current Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) diagnosis of alcohol dependence, supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders Patient Edition (SCID-I/P).
- •participants must meet criteria for heavy drinking, defined as averaging ≥4 drinks/day for women and ≥5 drinks/day for men during a consecutive 30-day period within the 90 days prior to baseline evaluation (see: Anton et al, 2006). The gender-specific baseline was chosen as it represents heavy drinking that exceeds empirically based levels of moderate alcohol use that result in alcohol-related problems for women who consume ≥4 drinks/day, and men who consume ≥5 drinks/day (Sanchez-Craig et al, 1995).
- •participants must be in good health as confirmed by medical history, physical examination, ECG, lab tests.
- •females must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine pregnancy test at each visit.
- •participants must be willing to take oral medication and adhere to the study procedures.
- •Exclusion criteria:
- •individuals expressing interest in treatment for alcoholism.
- •pregnancy or breast feeding women or not using an adequate form of birth control
- •positive urine drug screen at baseline for any illegal substance (a urine drug screen may be repeated once during the screening period).
Exclusion Criteria
- Not provided
Arms & Interventions
Baclofen
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
Intervention: Baclofen
Cyproheptadine
Cyproheptadine 2 mg t.i.d. for 8-10 days
Intervention: Cyproheptadine
Outcomes
Primary Outcomes
Alcohol Urge
Time Frame: approximately 8 days after drug administration
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
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).