Duloxetine Versus Pregabalin for Alcohol Dependence
This trial has been completed.
|Treatments||pregabalin, duloxetine, standardized behavioral therapy, placebo|
|Sponsor||The Scripps Research Institute|
|Collaborator||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Start date||July 2009|
|End date||October 2014|
|Trial size||150 participants|
|Trial identifier||NCT00929344, AA014028, MERIT, R37AA014028|
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. A cue reactivity session will be conducted at Week 2 to assess the predictive validity of the human laboratory model for determining the clinical efficacy of pregabalin and duloxetine.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Drinking Quantity and Frequency
time frame: 1 time per week for 12 weeks
Male or female participants at least 18 years old.
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),
|Official title||Duloxetine Versus Pregabalin for Alcohol Dependence|
|Principal investigator||Barbara J Mason, Ph.D.|
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