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

Alternate Title

Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Prevention Completed 18 to 67 Other PICS-R44-CA80525 NCI-V01-1662, NCT00021138

Objectives

I. Determine the effect of program length on inhaler use compliance, latency 
to smoking relapse, and gradual cessation of inhaler use in participants using 
a computer-assisted program to schedule nicotine inhaler dosing for smoking 
cessation.

II. Compare fast and slow paced versions of computer-assisted scheduling of 
nicotine inhaler use versus ad libitum nicotine inhaler use, in terms of 
smoking cessation rates, in these participants.

III. Compare these dosing conditions, in terms of adherence, initial dosing 
levels, and successful tapering effects, in these participants.

Entry Criteria

Disease Characteristics:

Smoker with a daily smoking rate between 15 and 40 cigarettes per day for at
least 2 years

Willing to quit smoking

Willing to use a nicotine inhaler

No concurrent use of smokeless tobacco, pipes, or cigars

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 No concurrent insulin

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 At least 1 month since prior bupropion or antidepressants
 At least 1 year since prior treatment for substance abuse
 No other concurrent nicotine replacement products

Patient Characteristics:

Age:
 18 to 67

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 No liver disease

Renal:
 No kidney disease

Cardiovascular:
 No history of heart disease
 No high blood pressure

Other:
 No stomach ulcers
 No overactive thyroid
 Not pregnant or nursing
 No plans to become pregnant within the next 6 months

Expected Enrollment

A total of 480 participants will be accrued for this study.

Outline

This is a randomized study.  Participants are randomized to one of three arms.

All participants monitor their period of cigarette smoking for 7 days by 
pressing a data input button on a hand-held computer every time they smoke.  

Arm I: Participants begin using a nicotine inhaler according to the dosing 
instructions that come with it and monitor their inhaler usage with the 
hand-held computer.

Arm II: Participants are prompted by the hand-held computer to use a nicotine 
inhaler based on their prior smoking habits.  When prompted, participants use 
the nicotine inhaler at a comfortable rate over 20 minutes.  The computer 
prompts participants at a fixed frequency and duration of inhaler use for 3 
weeks and then tapers the frequency and duration over 3-5 weeks.

Arm III: Participants are prompted by the hand-held computer and use a 
nicotine inhaler as in arm II.  The computer prompts participants at a fixed 
frequency and duration of inhaler use for 12 weeks and then tapers the 
frequency and duration over 3-5 weeks.

Participants keep a weekly diary of the average number of cigarettes smoked, 
average number of inhaler sessions, and average length of each session.  
Participants also record the date of any 24-hour smoking cessation and relapse 
and complete a withdrawal symptoms questionnaire.

Participants are followed at 1 year.

Trial Contact Information

Trial Lead Organizations

Personal Improvement Computer Systems, Incorporated

William Riley, PhD, Protocol chair		Ph: 703-758-0001

Registry Information
Official Title		Computerized Scheduling of Nicotine Inhaler Use
Trial Start Date		2001-04-01
Registered in ClinicalTrials.gov		NCT00021138
Date Submitted to PDQ		2001-05-17
Information Last Verified		2002-12-12