Duloxetine Versus Pregabalin for Alcohol Dependence
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Duloxetine
Standardized behavioral therapy
Standardized behavioral therapy
Placebo
Standardized behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol, Alcohol treatment, Alcoholism, Alcohol Abuse, Alcohol Dependence
Eligibility 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),
Sites / Locations
- The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Duloxetine
Pregabalin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00929344
First Posted
June 26, 2009
Last Updated
March 30, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00929344
Brief Title
Duloxetine Versus Pregabalin for Alcohol Dependence
Official Title
Duloxetine Versus Pregabalin for Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol, Alcohol treatment, Alcoholism, Alcohol Abuse, Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
Experimental
Arm Title
Pregabalin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized behavioral therapy
Other Intervention Name(s)
Manually-guided therapy
Intervention Description
Standardized behavioral therapy 1 time per week for 12 week duration.
Intervention Type
Behavioral
Intervention Name(s)
Standardized behavioral therapy
Other Intervention Name(s)
Manually-guided therapy
Intervention Description
Standardized behavioral therapy 1 time per week for 12 week duration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Intervention Type
Behavioral
Intervention Name(s)
Standardized behavioral therapy
Other Intervention Name(s)
Manually-guided therapy
Intervention Description
Standardized behavioral therapy 1 time per week for 12 week duration.
Primary Outcome Measure Information:
Title
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12
Description
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.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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),
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Links:
URL
http://alcoholismmarijuanatreatment.com/
Description
Study Information
Learn more about this trial
Duloxetine Versus Pregabalin for Alcohol Dependence
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