Varenicline for Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Varenicline; Placebo
Intervention description: 0.5mg capsules x 2, 2x a day for 12 weeks; identical matched placebo x 2, 2xday, 13 weeks
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol; Alcohol abuse; Alcoholism; Alcohol Dependence; Varenicline; Drinking

Summary:

      The primary objective of this study is to assess the efficacy of varenicline in reducing the
      proportion of heavy drinking days during the last 8 weeks of treatment in subjects with
      alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text
      Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day
      for men and 8 or more drinks for women (designated as "very heavy" drinkers).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be at least 18 years of age.

          2. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.

          3. Be seeking treatment for alcohol dependence and desire a reduction or cessation of
             drinking.

          4. Be able to verbalize an understanding of the consent form, able to provide written
             informed consent, verbalize willingness to complete study procedures, able to
             understand written and oral instructions in English and able to complete the
             questionnaires required by the protocol.

          5. Agree (if the subject is female and of child bearing potential) to use at least one of
             the following methods of birth control, unless she is surgically sterile, partner is
             surgically sterile or she is postmenopausal:

               1. oral contraceptives,

               2. contraceptive sponge,

               3. patch,

               4. double barrier (diaphragm/spermicidal or condom/spermicidal),

               5. intrauterine contraceptive system,

               6. levonorgestrel implant,

               7. medroxyprogesterone acetate contraceptive injection,

               8. complete abstinence from sexual intercourse,

               9. hormonal vaginal contraceptive ring, and/or

          6. Be able to take oral medication and be willing to adhere to the medication regimen

          7. Complete all assessments required at screening and baseline.

          8. Provide evidence of stable residence in the last 2 months prior to randomization, have
             reasonable transportation arrangements to the study site, and have no plans to move
             within the next 3 months or unresolved legal problems. Subjects must provide contact
             information of someone, such as a family member, spouse, or significant other, who may
             be able to contact the subject in case of a missed clinic appointment.

          9. Be willing to discontinue the use of nicotine replacement therapies prior to
             randomization and refrain from using nicotine replacement therapies during the course
             of the study.

         10. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the
             informed consent document.

         11. Be someone who in the opinion of the investigator would be expected to complete the
             study protocol.

         12. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend
             each scheduled visit, participate in phone visits and that s/he does not have any
             already scheduled events or a job that may interfere with study participation.