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Duloxetine Versus Pregabalin for Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT00929344
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : March 28, 2017
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Pregabalin Drug: Duloxetine Behavioral: Standardized behavioral therapy Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Duloxetine Versus Pregabalin for Alcohol Dependence
Study Start Date : July 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 Name: Cymbalta
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Other Name: Manually-guided therapy
Experimental: Pregabalin 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 Name: Lyrica
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Other Name: Manually-guided therapy
Placebo Comparator: Placebo Drug: Placebo
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Other Name: Manually-guided therapy



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929344


Locations
United States, California
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute

Additional Information:
Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00929344     History of Changes
Other Study ID Numbers: AA014028
R37AA014028 ( U.S. NIH Grant/Contract )
MERIT
First Posted: June 29, 2009    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: May 4, 2017
Last Verified: March 2017

Keywords provided by Barbara J. Mason, The Scripps Research Institute:
Alcohol
Alcohol treatment
Alcoholism
Alcohol Abuse
Alcohol Dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Pregabalin
Duloxetine Hydrochloride
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Antidepressive Agents
Dopamine Agents