Phase 2
N=150
Duloxetine Versus Pregabalin for Alcohol Dependence
Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00929344 ↗Enrolled (actual)
150
Serious AEs
4.0%
Results posted
Mar 2017
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pregabalin (Drug); Duloxetine (Drug); Standardized behavioral therapy (Behavioral); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Scripps Research Institute
- Primary completion
- Oct 2014
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 | — |
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.
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),
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.