Duloxetine Versus Pregabalin for Alcohol Dependence

The Scripps Research Institute

Status and phase: Completed; Phase 2

Conditions: Alcohol Dependence

Treatments: Behavioral: Standardized behavioral therapy; Drug: Placebo; Drug: Pregabalin; Drug: Duloxetine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00929344

AA014028

R37AA014028 (U.S. NIH Grant/Contract)

MERIT

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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),

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Duloxetine

Experimental group

Treatment:

Behavioral: Standardized behavioral therapy

Behavioral: Standardized behavioral therapy

Drug: Duloxetine

Behavioral: Standardized behavioral therapy

Pregabalin

Experimental group

Treatment:

Behavioral: Standardized behavioral therapy

Behavioral: Standardized behavioral therapy

Drug: Pregabalin

Behavioral: Standardized behavioral therapy

Placebo

Placebo Comparator group

Treatment:

Behavioral: Standardized behavioral therapy

Behavioral: Standardized behavioral therapy

Drug: Placebo

Behavioral: Standardized behavioral therapy