Bupropion in Helping Adults 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
Phase: Phase 2

Summary: 
      RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine
      withdrawal. Giving bupropion over a longer period of time may be effective in helping people
      stop smoking.

      PURPOSE: This randomized phase II trial is studying how well bupropion works in helping
      adults stop smoking.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the feasibility of conducting a full-scale clinical trial to evaluate whether
           extending the duration of pre-cessation bupropion hydrochloride enhances smoking
           cessation, as measured by 3-month prolonged abstinence rates, in adult smokers.

      Secondary

        -  Assess baseline smoking and mood characteristics (nicotine dependence, smoking history,
           anxiety, and depression).

        -  Assess measures to address the hypothesized extinction mechanism (subjective effects of
           smoking, collection of cigarette butts for an assessment of nicotine and tar exposure,
           craving for smoking, and expectations for the consequences of smoking).

        -  Assess changes in affective state as measured by Withdrawal Symptoms Checklist and by
           Positive and Negative Affect Schedule (PANAS) questionnaire.

        -  Assess side effects, pill counts, and changes in daily smoking rate.

        -  Assess mental health, personality traits, interpersonal skills, demand simulation,
           impulsivity, motivation, and perceived stress using validated measures.

      OUTLINE: Participants are stratified according to gender. Participants are randomized to 1 of
      2 pre-cessation intervention arms.

        -  Arm I (1-week run-in): Participants receive an oral placebo once or twice daily in weeks
           1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants
           also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.

        -  Arm II (4-week run-in): Participants receive oral bupropion hydrochloride once or twice
           daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling
           sessions once in weeks 1, 2, and 4.

      In both arms, participants are asked to quit smoking (target quit date) in week 5. All
      participants then receive oral bupropion hydrochloride once or twice daily in weeks 5-11 and
      undergo 90-minute behavioral group counseling sessions once in weeks 5, 7, and 9.

      Participants complete questionnaires to collect information on tobacco use history, health
      habits, depression, anxiety scales/symptoms, and sociodemographics at baseline. Participants
      also complete a series of validated questionnaires about smoking patterns, smoking
      satisfaction, mental health, personality traits, interpersonal skills, demand simulation,
      impulsivity, motivation, and perceived stress at baseline and then periodically during study.
      Participants undergo saliva sample collection at baseline and then periodically during study.
      Samples are analyzed for the presence of cotinine. Buccal cells are also collected at
      baseline for subsequent DNA analyses. Cigarette butts from the first cigarette of the day,
      including the quit day, are collected during group counseling sessions in weeks 1, 2, 4, and
      5 and are assessed for a marker that indicates the amount of nicotine and tar consumed.

      After finishing study treatment, participants are followed at 6 and 12 months.
    

Intervention name(s): bupropion hydrochloride; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Given orally
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
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