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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Martin Mahoney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000565103

NCT ID:

NCT00534001

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Cervical Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Tobacco Use Disorder
  • 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
  • Urinary Bladder Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Uterine Cervical Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Leukemia
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Tobacco Use Disorder

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263