Duloxetine Versus Pregabalin for Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:

Duloxetine Versus Pregabalin for Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929344
• Other study ID #: AA014028
• Secondary ID: R37AA014028MERIT
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2009
• Last updated: December 7, 2016
• Start date: July 2009
• Est. completion date: October 2014

Study information

• Verified date: December 2016
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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.
• 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.

Behavioral:
• Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
• Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.

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.

Locations

Country	Name	City	State
United States	The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drinking Quantity and Frequency		1 time per week for 12 weeks	No

External Links

•   Study Information