Duloxetine Versus Pregabalin for Alcohol Dependence
Completed · Phase 2 · Has a placebo group
Conditions studied: Alcohol Dependence
In brief
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.
Key facts
- Study ID
- NCT00929344
- Run by
- The Scripps Research Institute
- People needed
- 150
- Starts
- 2009-07-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2017-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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),
Where it is running
- The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research — La Jolla, California, United States
Full record on ClinicalTrials.gov
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