Duloxetine Versus Pregabalin for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Pregabalin; Duloxetine; Standardized behavioral therapy; Standardized behavioral therapy; Placebo; Standardized behavioral therapy
Intervention description: 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.; 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 1 time per week for 12 week duration.; Standardized behavioral therapy 1 time per week for 12 week duration.; Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.; Standardized behavioral therapy 1 time per week for 12 week duration.
Intervention MeSH terms: Pregabalin; Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol; Alcohol treatment; Alcoholism; Alcohol Abuse; Alcohol Dependence

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),