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Trial record 1 of 1 for:    n99c4
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Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033592
Recruitment Status : Completed
First Posted : February 6, 2004
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE April 9, 2002
First Posted Date  ICMJE February 6, 2004
Last Update Posted Date July 13, 2016
Study Start Date  ICMJE February 2002
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Prevention in relapse [ Time Frame: Up to 6 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Reduction in the rate of relapse [ Time Frame: Up to 6 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking
Official Title  ICMJE Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Brief Summary

RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.

PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.

Detailed Description

OBJECTIVES: I. Compare the effectiveness of nicotine inhaler vs bupropion vs nicotine inhaler plus bupropion on smoking cessation and prevention of relapse in participants who currently smoke. II. Compare the reduction in the rate of relapse to smoking after initial abstinence in participants treated long term with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, cigarettes smoked per day at time of screening (10-39 vs 40 or more), and total length of smoking in years (less than 5 vs 5-9 vs 10 or more). Participants are randomized to one of three treatment arms. Arm I: Participants receive 6-16 nicotine inhaler cartridges per day. Arm II: Participants receive oral bupropion 1-2 times daily. Arm III: Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily. In all arms, treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. Participants randomized to arm I who continue to smoke are randomized to one of two treatment arms. Arm IV: Participants receive oral bupropion 1-2 times daily for 12 weeks Arm V: Participants receive oral placebo 1-2 times daily for 12 weeks. Participants randomized to arm II who continue to smoke are randomized to one of two treatment arms. Arm VI: Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks. Arm VII: Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks. Participants randomized to arm III who continue to smoke do not receive any further therapy. Participants randomized to arm I who are smoke-free are randomized to one of two treatment arms. Arm VIII: Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks. Arm IX: Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks. Participants randomized to arm II who are smoke-free are randomized to one of two treatment arms. Arm X: Participants receive oral bupropion 1-2 times daily for 40 weeks. Arm XI: Participants receive oral placebo 1-2 times daily for 40 weeks. Participants randomized to arm III who are smoke-free are randomized to one of four treatment arms. Arm XII: Participants receive 6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. Arm XIII: Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. Arm XIV: Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. Arm XV: Participants receive 6-16 placebo inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Other: placebo
  • Drug: bupropion hydrochloride
  • Drug: nicotine
Study Arms  ICMJE
  • Experimental: Arm I: nicotine inhaler cartridges

    Participants receive 6-16 nicotine inhaler cartridges per day. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.

    Participants randomized to arm I who continue to smoke are randomized to one of two treatment arms Arm IV or Arm V. Participants randomized to arm I who are smoke-free are randomized to one of two treatment arms Arm VIII or Arm IX.

    Intervention: Drug: nicotine
  • Experimental: Arm II: bupropion

    Participants receive oral bupropion 1-2 times daily.

    Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.

    Participants randomized to arm II who continue to smoke are randomized to one of two treatment arms Arm VI or Arm VII. Participants randomized to arm II who are smoke-free are randomized to one of two treatment arms Arm Arm X or Arm XI.

    Intervention: Drug: bupropion hydrochloride
  • Experimental: Arm III: nicotine inhaler cartridges

    Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.

    Participants randomized to arm III who continue to smoke do not receive any further therapy. Participants randomized to arm III who are smoke-free are randomized to one of four treatment arms Arm XII, Arm XIII, Arm XIV or Arm XV.

    Intervention: Drug: nicotine
  • Experimental: Arm IV: bupropion

    Participants receive oral bupropion 1-2 times daily for 12 weeks.

    All participants are followed every month for 6 months.

    Intervention: Drug: bupropion hydrochloride
  • Placebo Comparator: Arm V: placebo

    Participants receive oral placebo 1-2 times daily for 12 weeks.

    All participants are followed every month for 6 months.

    Intervention: Other: placebo
  • Experimental: Arm VI: nicotine inhaler cartridges

    Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks.

    All participants are followed every month for 6 months.

    Intervention: Drug: nicotine
  • Placebo Comparator: Arm VII: placebo inhaler

    Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks.

    All participants are followed every month for 6 months.

    Intervention: Other: placebo
  • Experimental: Arm VIII: nicotine inhaler cartridges

    Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Drug: nicotine
  • Placebo Comparator: Arm IX: placebo inhaler cartridges

    Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Other: placebo
  • Experimental: Arm X: bupropion

    Participants receive oral bupropion 1-2 times daily for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Drug: bupropion hydrochloride
  • Placebo Comparator: Arm XI: placebo

    Participants receive oral placebo 1-2 times daily for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Other: placebo
  • Experimental: Arm XII: nicotine inhaler cartridges

    Participants receive 6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Drug: nicotine
  • Placebo Comparator: Arm XIII: placebo inhaler cartridges

    Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Other: placebo
  • Experimental: Arm XIV: nicotine inhaler cartridges

    Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Drug: nicotine
  • Placebo Comparator: Arm XV: placebo inhaler cartridges

    Participants receive 6-16 placebo inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks.

    All participants are followed every month for 6 months.

    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
1708
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Currently smoking at least 10 cigarettes per day Smoked regularly for the past year Motivated to use study medication More than 30 days since prior use of tobacco products other than cigarettes (e.g., smokeless tobacco, pipes, cigars, or snuff) No active chemical dependence of drug other than nicotine (e.g., alcohol, marijuana, cocaine, heroin, or other illicit drugs) within the past year

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No unstable angina, myocardial infarction, or cardiac arrhythmias within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 3 months prior to and during study Good health by medical history No history of seizure disorder No epilepsy No prior serious head trauma or other predisposing factors to seizures (e.g., alcohol withdrawal, febrile seizures during childhood, brain tumor, cerebrovascular accident, or family history of idiopathic seizure disorder) No known hypersensitivity or allergy to nicotine, menthol, or bupropion No prior or concurrent diagnosis of bulimia or anorexia nervosa No other member of household currently enrolled on this study No bipolar disorder, psychosis, or schizophrenia

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: More than 30 days since prior systemic steroids Radiotherapy: Not specified Surgery: Not specified Other: More than 30 days since other prior behavioral or pharmacologic smoking- cessation program (e.g., behavioral therapy, nicotine replacement therapy, clonidine, bupropion, nortriptyline, or doxepin) More than 30 days since prior investigational drugs More than 30 days since prior antipsychotics or antidepressants More than 30 days since prior theophylline More than 30 days since prior monoamine oxidase inhibitor More than 30 days since prior medication containing bupropion No concurrent antiepileptic medications No concurrent medications known to lower seizure threshold No other concurrent investigational drugs

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00033592
Other Study ID Numbers  ICMJE NCCTG-N99C4
CDR0000069303 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-P02-0220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Richard D. Hurt, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP