Varenicline (Chantix™) for the Treatment of Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: varenicline; placebo
Intervention description: 1.0 mg BID for 12 weeks; BID 12 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: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: alcohol; treatment; nicotinic acetylcholine receptors; pharmacotherapy; outpatient

Summary:

      The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the
      treatment of alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Males and females, 18-70 years old.

          -  2. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by
             the SCID-IV (First, 1996).

          -  3. Meets the following drinking criteria as measured by the Timeline Followback (TLFB)
             (Sobell, 1995)

          -  drank within 30 days of intake day,

          -  reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive
             30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40%
             days drinking), and

          -  has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and
             4 or more drinks per day in females) in this same pre-treatment period.

          -  4. Three consecutive days of abstinence from alcohol, determined by self-reports and
             confirmed by a negative breathalyzer tests immediately before the day of
             randomization, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR)
             (Sullivan, 1989) score below eight on the day of randomization.

          -  5. Lives a commutable distance from the TRC and agrees to attend all research visits
             including follow-up visits.

          -  Speaks, understands, and prints in English.

        Exclusion Criteria:

          -  Has evidence of dependence on a substance other than alcohol (except nicotine or
             marijuana); or tests positive on the urine drug screen and on a single allowed retest,
             during the screening week, with the exception of a THC positive urine, and/or
             a).positive result for benzodiazepines prescribed by a doctor for medically indicated
             detox (prescription required).

          -  Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at
             least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin
             (>1.3) (one retest allowed at the discretion of the Medical Director).

          -  Meets diagnostic criteria for a current unstable or serious psychiatric or medical
             illness. For example, bipolar affective disorder, schizophrenia or any other psychotic
             disorder, or organic mental disorder; has serious heart, lung, kidney, immune system,
             GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding)
             disease.

          -  Has taken any psychotropic medications (including disulfiram, naltrexone or
             acamprosate) regularly within the last 2 weeks or needs immediate treatment with a
             psychotropic medication (with the exception of detoxification medications or benadryl
             used sparingly for sleep).

          -  Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months,
             is nursing, or is not using an effective contraceptive method if the subject is of
             child-bearing potential.

          -  Has participated in any investigational drug trial within 30 days prior to the study.
             Subjects mandated to treatment based upon a legal decision or as a condition of
             employment. This will be assessed by the subject's self-report.

          -  Known hypersensitivity to varenicline.

          -  Subjects with known AIDS or other serious illnesses that may require hospitalization
             during the study.

          -  Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits
             that are clinically unacceptable to the Principal Investigator. (ECG 1st degree heart
             block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes
             are allowed; liver function tests [LFTs] <5 x ULN are acceptable).