Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Condition: Smoking Cessation; Alcohol Drinking
MeSH terms: Alcoholic Intoxication; Alcohol Drinking
Intervention: Chantix; Behavioral Counseling Sessions; NicodermCQ; Placebo
Intervention description: Chantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]; One-to-one behavioral counseling sessions with a trained therapist; Nicotine patches provided over 12 week participation; Identical in appearance to varenicline [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Varenicline

Summary:

      The purpose of this study is to learn if the combination of a study drug and patch is more
      effective in helping heavy drinkers stop smoking than just the patch alone The study drug,
      varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop
      smoking, but it is not known if the addition of varenicline to standard smoking cessation
      treatment with nicotine patches will help people stop smoking who are regular, frequent
      drinkers. This study is being done because cigarette smoking is the number one preventable
      cause of death and disease in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoke 3-30 cigarettes/day

          -  Desire to quit smoking as indicated on a smoking stages ladder

          -  Consume >14 (men) or >7 (women) standard alcohol drinks per week (e.g., 1 drink = 12
             oz beer, 5 oz wine, 1.5 oz liquor)

          -  Ability to understand, read, and write in English, at least 8th grade education

          -  Willing and able to sign an informed consent

          -  Stable residence and contact information.

        Exclusion Criteria:

          -  Hepatic panel indices > 2 SD

          -  History of seizures or DTs during alcohol withdrawal

          -  Unstable medical (e.g., hepatitis, cirrhosis, seizure disorder, recent major
             cardiovascular event, etc.) or psychiatric disorder (e.g., active hallucinations,
             severe depression, obsessional thinking, self-injury risking significant blood loss,
             etc.) deemed by the study physician to be at significant risk for adverse interactions
             with study medications or measures.

          -  History of adverse reactions to varenicline (VAR) or nicotine patch

          -  Current suicidal ideation (past 6 months) and/or history of major suicide attempts.

          -  For women of child-bearing potential: currently pregnant, lactating, current plans to
             become pregnant in next three months, or unable to agree to adequate birth control
             during study participation.