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Completed

NCT Number: NCT00929344

Duloxetine Versus Pregabalin for Alcohol Dependence

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

Pregabalin

Drug

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.

Other names: Lyrica

Duloxetine

Drug

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.

Other names: Cymbalta

Standardized behavioral therapy

Behavioral

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

Other names: Manually-guided therapy

Placebo

Drug

Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.

Primary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

The Scripps Research Institute

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 29, 2009
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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