Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking
|ClinicalTrials.gov Identifier: NCT00021138|
Recruitment Status : Completed
First Posted : March 19, 2004
Last Update Posted : May 15, 2013
RATIONALE: Computer-assisted scheduling of nicotine inhaler use may be an effective method to help people stop smoking.
PURPOSE: Randomized cinical trial to compare the effectiveness of computer-assisted scheduling of nicotine inhaler use with that of self-scheduled nicotine inhaler use in participants who plan to stop smoking.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Head and Neck Cancer Lung Cancer||Behavioral: smoking cessation intervention Drug: nicotine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Computerized Scheduling of Nicotine Inhaler Use|
|Study Start Date :||April 2001|
|Actual Study Completion Date :||March 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021138
|United States, Virginia|
|Personal Improvement Computer Systems, Incorporated|
|Reston, Virginia, United States, 20191|
|Study Chair:||William Riley, PhD||Personal Improvement Computer Systems|