Bupropion in Helping Adults Stop Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00534001
First received: September 20, 2007
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
Drug: bupropion hydrochloride
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Role of pre-cessation bupropion hydrochloride effects in smoking cessation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: January 2006
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: bupropion hydrochloride
Given orally
Other: placebo
Given orally
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.
Drug: bupropion hydrochloride
Given orally

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534001

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Martin Mahoney, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00534001     History of Changes
Other Study ID Numbers: CDR0000565103, I 57805
Study First Received: September 20, 2007
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Leukemia
Liver Neoplasms
Lung Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Tobacco Use Disorder
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014