Duloxetine Versus Pregabalin for Alcohol Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by The Scripps Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00929344
First received: June 26, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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. A cue reactivity session will be conducted at Week 2 to assess the predictive validity of the human laboratory model for determining the clinical efficacy of pregabalin and duloxetine.


Condition Intervention Phase
Alcohol Dependence
Drug: Pregabalin
Drug: Duloxetine
Behavioral: Standardized behavioral therapy
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Duloxetine Versus Pregabalin for Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Drinking Quantity and Frequency [ Time Frame: 1 time per week for 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine Drug: Duloxetine
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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),
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929344

Contacts
Contact: Susan B Quello, BA, BS 858-784-7327 squello@scripps.edu

Locations
United States, California
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research Recruiting
La Jolla, California, United States, 92037
Contact: Susan B Quello, BA, BS    858-784-7327    squello@scripps.edu   
Principal Investigator: Barbara J Mason, Ph.D.         
Sponsors and Collaborators
The Scripps Research Institute
Investigators
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00929344     History of Changes
Other Study ID Numbers: AA014028, R37AA014028, 5R37AA014028
Study First Received: June 26, 2009
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Duloxetine
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014