Phase 2 Completed N=150 Randomized Double-blind Treatment

Duloxetine Versus Pregabalin for Alcohol Dependence

alcohol dependence

Source: ClinicalTrials.gov NCT00929344 ↗

Enrolled (actual)

150

Serious AEs

4.0%

Results posted

Mar 2017

Primary outcomePrimary: Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12 — 42.07; 56.67; 41.20; 9.16 drinks/week

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	42.07; 56.67; 41.20; 9.16; 7.59; 8.06	—
PRIMARY Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12	5.11; 4.54; 4.87; 2.17; 1.14; 1.85	—
PRIMARY Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12	8.16; 12.98; 8.91; 2.21; 2.31; 2.90	—

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),

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00929344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.