Duloxetine Versus Pregabalin for Alcohol Dependence

The Scripps Research Institute150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Alcohol Dependence

Interventions

PregabalinDRUG

Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.

DuloxetineDRUG

40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.

Standardized behavioral therapyBEHAVIORAL

Standardized behavioral therapy 1 time per week for 12 week duration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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),

Locations (1)

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12

Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.

Time frame: Baseline and Week 12

Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12

Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.

Time frame: Baseline and Week 12

Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12

Time frame: Baseline and Week 12

Data from ClinicalTrials.gov

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