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Alcohol Dependence | Duloxetine Versus Pregabalin for Alcohol Dependence

Alcohol Dependence research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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),

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Alcohol Dependence

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PregabalinTwo 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.

Drug:Duloxetine40 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.

Behavioral:Standardized behavioral therapyStandardized behavioral therapy 1 time per week for 12 week duration.

Behavioral:Standardized behavioral therapyStandardized behavioral therapy 1 time per week for 12 week duration.

Drug:PlaceboMatched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.

Behavioral:Standardized behavioral therapyStandardized behavioral therapy 1 time per week for 12 week duration.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Duloxetine

Pregabalin

Placebo

Study Status

Completed

Start Date: July 2009

Completed Date: October 2014

Phase: Phase 2

Type: Interventional

Design:

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

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Barbara J Mason, Ph.D.

Lead Sponsor: The Scripps Research Institute

Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More information:https://clinicaltrials.gov/show/NCT00929344

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