Bladder Cancer Clinical Trial
Bupropion in Helping Adults Stop Smoking
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.
Full 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.
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)
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There is 1 Location for this study
Buffalo New York, 14263, United States
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