Duloxetine Versus Pregabalin for Alcohol Dependence

Duloxetine Versus Pregabalin for Alcohol Dependence

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.

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),