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
Intervention: bupropion hydrochloride; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Currently smokes ≥ 15 cigarettes per day for at least 1 year

          -  Motivated to quit smoking within the next 3 months

        PATIENT CHARACTERISTICS:

          -  Willing to attend clinic visits

          -  Willing to refrain from nicotine replacement therapy (NRT) use during study
             participation

          -  Able to speak and read English fluently

          -  Has a home telephone and plans to reside in Western New York for the next year

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Not planning a pregnancy

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  No history of chronic renal or hepatic disease

          -  No history of head trauma or seizure

          -  No history of a seizure disorder, brain tumor, or CNS tumor

          -  No history of or currently diagnosed bulimia or anorexia nervosa

          -  No history of psychotic disorder

          -  No diabetes requiring oral hypoglycemics or insulin

          -  No excessive use of alcohol or alcoholism

          -  No current addiction to opiates, cocaine, or stimulants

          -  No poorly controlled hypertension (i.e., systolic blood pressure [BP] > 170 mm Hg
             and/or diastolic BP > 110 mm Hg)

          -  No allergy to bupropion hydrochloride

          -  No other surgical or medical condition that may significantly alter absorption,
             distribution, metabolism, or excretion of bupropion hydrochloride

          -  No history of noncompliance to medical regimens

          -  No other clinical contraindication

          -  No major depressive disorder

        PRIOR CONCURRENT THERAPY:

          -  At least 14 days since prior and no concurrent monoamine oxidase inhibitor

          -  No recent discontinuation of a benzodiazepine

          -  No concurrent Hypericum perforatum (St. John's wort)

          -  No other concurrent drugs containing bupropion hydrochloride (e.g., Wellbutrin or
             Zyban)

          -  No concurrent antipsychotics, antidepressants, theophylline, systemic steroids,
             over-the-counter stimulants or anorectics, or levodopa

          -  No concurrent active treatment for cancer (e.g., chemotherapy or radiotherapy)