Bupropion in Helping Adults Stop Smoking

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation

Conditions
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Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

Intervention / Treatment
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* Drug: bupropion hydrochloride
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (1-week run-in)<br>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. | Drug: bupropion hydrochloride<br>* Given orally<br>Other: placebo<br>* Given orally<br>|
| Experimental: Arm II (4-week run-in)<br>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. | Drug: bupropion hydrochloride<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prequit Change in Cigarettes Per Day | Prequit Change in Cigarettes Per Day | 3-Week PreQuit Drug Manipulation Phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence | Bioverified 4-week continuous abstinence | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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