Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Condition: Smoking Cessation; Alcohol Drinking
MeSH terms: Alcoholic Intoxication; Alcohol Drinking
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This study will conduct a real-world clinic-based smoking cessation trial examining the
      augmentation strategy of Chantix (Varenicline Tartrate), nicotine patch, and behavioral
      counseling versus standard treatment of patch plus behavioral counseling only in heavy
      drinkers who smoke (HDS). While Chantix is approved for smoking cessation, it is not
      routinely given in practice for HDS patients

      In this study, there will be 4 total in-person study visits over the trial (pre-quit, quit
      date, week 2 and week 12), ending 12 weeks after the quit date. Biochemical verification from
      breath tests for CO, as well as vital signs and weight, will be measured at each visit along
      with survey responses measuring smoking urge and withdrawal, negative affect, neurocognition,
      and alcohol and smoking behaviors. These will also be used at a 26-week follow-up by
      telephone with biochemical verification for CO in those reporting being smoke-free.

      Screening and Randomization Participants will respond to advertisements and will undergo a
      brief phone screening to determine initial eligibility requirements. Qualified candidates
      will be invited into the lab to conduct a short screening and study information session at
      the Clinical Addictions Research Laboratory at the University of Chicago. At screening,
      participants will sign an informed consent document. Next, demographics, smoking, alcohol and
      substance use patterns, health history, medications, vital signs, a urine test (for pregnancy
      and/or drug toxicology) and a blood test will be obtained.

      Eligible participants will be randomized into one of two treatment groups: Standard Treatment
      (w/ placebo) will proceed with the study receiving nicotine patches and brief counseling
      sessions; Augmented Treatment will proceed with the same nicotine patches and brief
      counseling sessions, but will also receive standard dosing of Chantix (Varenicline tartrate).

      Nicotine Patches Nicotine patches will be utilized starting at study quit date, and proceed
      according to package insert directions (10+ cigs/day smokers will begin with 21mg patches for
      six weeks, followed by 14mg patches for four weeks, and finally 7mg patches for two weeks.
      Those smoking fewer than 10 cigarettes/day will follow the same process starting at the 14mg
      patch level.

      Chantix (Varenicline Tartrate) Those receiving Augmented Treatment will receive varenicline.
      They will undergo an up-titration week prior to the quit date, 12 weeks of target dosing, and
      a down-titration week. As per Pfizer recommendations, up-titration will be 0.5mg tablets once
      daily for 3 days followed by twice daily for four days leading to the quit date on day 8. The
      sequence will reverse for a down-titration week on week 13.

      Placebo for Varenicline Those receiving standard treatment will also receive placebo
      medication that will be identical in appearance to and follow the same distribution protocol
      as varenicline.

      Smoking Cessation Behavioral Sessions:

      Participants will attend one-on-one behavioral counseling sessions with a trained Masters or
      PhD. Level therapist at each study visit. Behavioral sessions will involve teaching
      behavioral skills to assist with smoking cessation, preventing relapse, and coping with
      physical or emotional changes associated with cravings. At each study visit, subjective
      measures (i.e. brief self-report surveys about

      Follow-Up Interview (Week 26) At Study Week 26, participants will complete a follow-up
      telephone interview, completing similar subjective measures as those completed during study
      visits. Participants reporting being smoke-free during this interview will arrange for
      biochemical verification of this status via expired CO testing either by arranging for a time
      to stop into one of the study sites or by arranging for study staff to meet with them in
      their home or workplace.
    

Intervention name(s): Chantix; Behavioral Counseling Sessions; NicodermCQ; Placebo
Intervention type(s): Drug; Behavioral; Drug; Drug
Intervention description(s): 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]
Other intervention name(s): Varenicline Tartrate; Transdermal Nicotine Patch
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Varenicline