Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Completed 18 and over NCI NCCTG-N99C4 NCI-P02-0220, NCT00033592

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.
 

Entry Criteria

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

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

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 

Expected Enrollment

Approximately 1850 participants (616 per treatment arm of the initial 
randomization) will be accrued for this study within 6 months.

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Richard Hurt, MD, Protocol chair		Ph: 507-284-4642

Registry Information
Official Title		Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Trial Start Date		2002-02-13
Registered in ClinicalTrials.gov		NCT00033592
Date Submitted to PDQ		2002-02-22
Information Last Verified		2006-11-17
NCI Grant/Contract Number		CA025224

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