Status:
COMPLETED
Duloxetine Versus Pregabalin for Alcohol Dependence
Lead Sponsor:
The Scripps Research Institute
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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),
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00929344
Start Date
July 1 2009
End Date
October 1 2014
Last Update
May 4 2017
Active Locations (1)
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1
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, United States, 92037