Duloxetine Versus Pregabalin for Alcohol Dependence

Phase 2

Completed

Interventions: Drug: Placebo
Drug: Duloxetine
Drug: Pregabalin
Behavioral: Standardized behavioral therapy

Brief Summary: A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.

Recruitment & Eligibility

Inclusion Criteria

Males or females 18 years of age
Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,
Seeking research-based outpatient treatment for alcohol problems
Willing to attend 12 weekly study visits and 2 follow-up visits
Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency

Exclusion Criteria

Active suicidal ideation
Medical disorders that will increase potential risk or interfere with study participation
Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
Males who refuse to use a reliable method of birth control
Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.
Inability to understand and/or comply with the provisions of the protocol and consent form
Treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization
Ongoing treatment with disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain
Ongoing treatment with drugs that may increase potential risk (Actos),

Arm && Interventions

Group	Intervention	Description
Pregabalin	Standardized behavioral therapy	-
Placebo	Placebo	-
Placebo	Standardized behavioral therapy	-
Duloxetine	Standardized behavioral therapy	-
Duloxetine	Duloxetine	-
Pregabalin	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Baseline and Week 12	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12	Baseline and Week 12	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12	Baseline and Week 12	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.