Clinical trial NCT00534001: Bupropion in Helping Adults Stop Smoking
Official title: A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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)

Primary outcomes:
measure: Prequit Change in Cigarettes Per Day
timeFrame: 3-Week PreQuit Drug Manipulation Phase
Secondary outcomes:
measure: Abstinence
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Martin Mahoney, MD
role: PRINCIPAL_INVESTIGATOR
References: