Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021138
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2001-07-11
Brief Title:
Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking
Sponsor:
Personal Improvement Computer Systems
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Computerized Scheduling of Nicotine Inhaler Use
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068751 | REGISTRY | None | None |
| NCI-V01-1662 | Registry Identifier | PDQ Physician Data Query | None |