Overview

This trial has been completed.

Condition alcohol dependence
Treatments pregabalin, duloxetine, standardized behavioral therapy, placebo
Phase phase 2
Sponsor The Scripps Research Institute
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date July 2009
End date October 2014
Trial size 150 participants
Trial identifier NCT00929344, AA014028, MERIT, R37AA014028

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
duloxetine Cymbalta
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.
standardized behavioral therapy Manually-guided therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
(Experimental)
pregabalin Lyrica
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.
standardized behavioral therapy Manually-guided therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
(Placebo Comparator)
placebo
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
standardized behavioral therapy Manually-guided therapy
Standardized behavioral therapy 1 time per week for 12 week duration.

Primary Outcomes

Measure
Drinking Quantity and Frequency
time frame: 1 time per week for 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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),

Additional Information

Official title Duloxetine Versus Pregabalin for Alcohol Dependence
Principal investigator Barbara J Mason, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by The Scripps Research Institute.