Varenicline Treatment of Alcohol Dependence in Smokers
Condition: Alcoholism; Alcohol Abuse; Smoking; Alcohol Drinking
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Varenicline
Intervention description: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: alcohol-related disorders; Cholinergic Drugs; varenicline; Chantix

Summary:

      The purpose of this study is to determine whether varenicline is effective in the treatment
      of alcohol dependence in smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are 18 - 70 years of age and seeking treatment of alcohol drinking;

          -  meet DSM-IV TR Criteria for Alcohol Dependence

          -  report smoking 100 cigarettes or more in their lifetime and currently smoke at least
             twice weekly on average in the past 90 days and have a urinary cotinine level of >
             30ng/mL by semi-quantitative urinalysis or equivalent plasma cotinine level (> 6
             ng/mL);

          -  report heavy drinking on at least 2 days on average per week (i.e., ≥ 4 drinks on an
             occasion for women and ≥ 5 drinks for men) for the past 90 days and no more than 7
             consecutive days of abstinence at intake.

        Exclusion Criteria:

          -  exhibit current, clinically significant physical disease or abnormality based on
             medical history, physical examination, or routine laboratory evaluation including:

               -  any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)

               -  clinically significant, unstable cardiovascular disease/uncontrolled hypertension

               -  hepatic or renal impairment

               -  severe obstructive pulmonary disease

               -  diabetes mellitus requiring insulin or certain oral medications (i.e.,
                  sulfonylureas) and an A1C hemoglobin test score of > 7 for participants not
                  prescribed these medications

               -  baseline systolic blood pressure higher than 150 mm Hg or diastolic blood
                  pressure higher than 95 mm Hg

          -  have a history of cancer (except treated basal cell or squamous cell carcinoma of the
             skin)

          -  have a history of serious hypersensitivity reactions or skin reactions to varenicline;

          -  exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe
             major depression, panic disorder, borderline personality disorder, organic mood or
             mental disorders by history or psychological examination

          -  report current suicidal ideation (past 6 months) or lifetime hx of suicidal behavior
             assessed with the Columbia Suicide Severity Rating Scale 60; or risk for aggression
             using a cut-off of 15 or more on the Overt Aggression Scale - Modified Aggression
             Scale or 6 or more on the OAS-M Irritability Subscale 61.

          -  have used any psychotropic drug in the past month, except individuals who are on a
             stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months or who
             report occasional use of prescription sleep aids that they are willing to discontinue;

          -  have a current DSM-IV diagnosis of drug dependence other than nicotine or alcohol

          -  are at risk for an alcohol withdrawal syndrome as evidenced by:

               -  a history of seizures, delirium, or hallucinations during alcohol withdrawal

               -  a Clinical Institute Withdrawal Assessment scale 62 score of > 8,

               -  report drinking to avoid withdrawal symptoms

               -  have required medical treatment of alcohol withdrawal within the past 6 months

          -  have used another investigational drug within 30 days or have used medications to
             treat alcohol (e.g., naltrexone, topiramate, acamprosate, disulfiram) or nicotine use
             (e.g., clonidine, varenicline, bupropion, nicotine replacement) in the past 3 months
             or intend to use these medications;prior use of nicotine replacement in situations
             where smoking is not permitted (e.g., planes) without the intention to quit smoking is
             not exclusionary;

          -  intend to donate blood or blood products during the treatment phase of the study

          -  have a Body Mass Index (calculated as weight in kilograms divided by the square of
             height in meters) less than 15 or greater than 39.99 or weight less than 45 kg;

          -  are a female of childbearing potential who is pregnant, nursing, or not practicing
             effective contraception (oral, injectable, or implantable contraceptives, intrauterine
             device, or barrier method with spermicide).