Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Bupropion in Helping Adults Stop Smoking

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Behavioral study, Educational/Counseling/Training, Prevention	Closed	18 to 65	NCI	RPCI-I-57805 I 57805, NCT00534001

Objectives

Primary

1. 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

1. Assess baseline smoking and mood characteristics (nicotine dependence, smoking history, anxiety, and depression).
2. 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).
3. Assess changes in affective state as measured by Withdrawal Symptoms Checklist and by Positive and Negative Affect Schedule (PANAS) questionnaire.
4. Assess side effects, pill counts, and changes in daily smoking rate.
5. Assess mental health, personality traits, interpersonal skills, demand simulation, impulsivity, motivation, and perceived stress using validated measures.

Entry Criteria

Disease Characteristics:

• Currently smokes ≥ 15 cigarettes per day for at least 1 year



• Motivated to quit smoking within the next 3 months

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)

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

Expected Enrollment

Outcomes

Effect of bupropion hydrochloride on changes in smoking behavior as well as smoking satisfaction, craving, and withdrawal as determined during the pre-cessation phase
Role of pre-cessation bupropion hydrochloride effects in smoking cessation

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Martin Mahoney, MD, Principal investigator		Ph: 716-845-3597; 800-685-6825

Registry Information
Official Title		A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation
Trial Start Date		2006-01-24
Trial Completion Date		2010-05-09 (estimated)
Registered in ClinicalTrials.gov		NCT00534001
Date Submitted to PDQ		2007-08-27
Information Last Verified		2008-10-23
NCI Grant/Contract Number		CA16056

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