Duloxetine Versus Pregabalin for Alcohol Dependence

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Scripps Research Institute
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Duloxetine Hydrochloride; Ethanol; Pregabalin

Criteria

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),