Duloxetine Versus Pregabalin for Alcohol Dependence

March 30, 2017 updated by: Barbara J. Mason, The Scripps Research Institute
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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),

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Other Names:
  • Manually-guided therapy
Drug: Placebo
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Experimental: Duloxetine
Drug: Duloxetine
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
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Other Names:
  • Manually-guided therapy
Experimental: Pregabalin
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Other Names:
  • Manually-guided therapy
Drug: Pregabalin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 12
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Scripps Research Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA014028
  • R37AA014028 (U.S. NIH Grant/Contract)
  • MERIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Dependence

Clinical Trials on Duloxetine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe