Duloxetine Versus Pregabalin for Alcohol Dependence
3 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
March 28, 2017
CompletedMay 4, 2017
March 1, 2017
5.3 years
June 26, 2009
February 8, 2017
March 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at 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
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
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
Study Arms (3)
Duloxetine
EXPERIMENTALPregabalin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
Standardized behavioral therapy 1 time per week for 12 week duration.
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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),
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, 92037, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara J. Mason, Ph.D.
- Organization
- The Scripps Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara J Mason, Ph.D.
The Scripps Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 29, 2009
Study Start
July 1, 2009
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
May 4, 2017
Results First Posted
March 28, 2017
Record last verified: 2017-03