Duloxetine Versus Pregabalin for Alcohol Dependence

Study Overview
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Brief Summary
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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.

Official Title
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Duloxetine Versus Pregabalin for Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Duloxetine
* Behavioral: Standardized behavioral therapy
* Behavioral: Standardized behavioral therapy
* Drug: Placebo
* Behavioral: Standardized behavioral therapy


Participation Criteria
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Eligibility Criteria
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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),

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br> | Drug: Duloxetine<br>* 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.<br>* Other names: Cymbalta;Behavioral: Standardized behavioral therapy<br>* Standardized behavioral therapy 1 time per week for 12 week duration.<br>* Other names: Manually-guided therapy;|
| Experimental: Pregabalin<br> | Drug: Pregabalin<br>* 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.<br>* Other names: Lyrica;Behavioral: Standardized behavioral therapy<br>* Standardized behavioral therapy 1 time per week for 12 week duration.<br>* Other names: Manually-guided therapy;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.<br>Behavioral: Standardized behavioral therapy<br>* Standardized behavioral therapy 1 time per week for 12 week duration.<br>* Other names: Manually-guided therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline and Week 12 | 
| Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day 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. | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol treatment, Alcoholism, Alcohol Abuse, Alcohol Dependence, Alcohol