Trial Information

Computerized Scheduling of Nicotine Inhaler Use

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.

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.

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