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

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.

Study Type: Interventional

Study Design: Other, Randomized

Study Primary Completion Date: May 2010

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(s) in this Clinical Trial

• Drug: bupropion hydrochloride
  • Given orally
• Other: placebo
  • Given orally

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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.
• Experimental: 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.

Primary Measures

• Effect of bupropion hydrochloride on changes in smoking behavior as well as smoking satisfaction, craving, and withdrawal as determined during the pre-cessation phase
  • Safety Issue?: No
• Role of pre-cessation bupropion hydrochloride effects in smoking cessation
  • Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Roswell Park Cancer Institute

Overall Clinical Trial Officials and Contacts

Martin Mahoney, MD Principal Investigator Roswell Park Cancer Institute  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00534001

Study ID Number: CDR0000565103

ClinicalTrials.gov Identifier: NCT00534001

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database