Duloxetine Versus Pregabalin for Alcohol Dependence
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | November 2016 |
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.
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.
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),
We found this trial at
1
site
La Jolla, California 92037
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