Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
Condition: Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Tobacco Use Disorder
Study type: Interventional

Summary: 
      RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is
      not yet known whether varenicline is more effective than the nicotine patch given together
      with nicotine gum in helping smokers quit smoking.

      PURPOSE: This randomized clinical trial is studying varenicline to see how well it works
      compared with the nicotine patch given together with nicotine gum in helping smokers in a
      methadone treatment program stop smoking.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher
           rate of smoking cessation than combination nicotine replacement therapy with nicotine
           patch prescription plus ad libitum nicotine gum delivery in methadone-maintained
           smokers.

      Secondary

        -  To test the effects of the treatments on smoking urges, withdrawal symptoms, and
           reinforcing effects of smoking.

        -  To test the effects of the treatments on methadone treatment outcomes, including
           retention in methadone maintenance, methadone dose changes, and continued use of illicit
           drugs as measured by urine toxicologies.

      OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of
      nicotine dependence. Patients are randomized to 1 of 3 intervention arms.

      At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple
      smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.

        -  Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice
           daily thereafter for a total of 6 months or when a comfortable level of smoking
           abstinence is reached.

        -  Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and
           twice daily thereafter for a total of 6 months or when a comfortable level of smoking
           abstinence is reached.

        -  Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering
           over time for a total of 26 weeks. Patients also receive nicotine gum to quell
           breakthrough urges. Patients may stop treatment when a comfortable level of smoking
           abstinence is reached.

      Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months
      1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath
      samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).

      NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.

      PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine
      replacement therapy, and 86 receiving placebo) will be accrued for this study.
    

Intervention name(s): nicotine; varenicline; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Given transdermally and orally; Given orally; Given orally
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: bladder cancer; cervical cancer; esophageal cancer; gastric cancer; renal cell carcinoma; adult primary liver cancer; non-small cell lung cancer; small cell lung cancer; pancreatic cancer; hypopharyngeal cancer; laryngeal cancer; lip and oral cavity cancer; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; adult acute myeloid leukemia; tobacco use disorder