Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking
|First Received Date ICMJE||July 11, 2001|
|Last Updated Date||May 14, 2013|
|Start Date ICMJE||April 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00021138 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking|
|Official Title ICMJE||Computerized Scheduling of Nicotine Inhaler Use|
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.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Primary Purpose: Prevention|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||March 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
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
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
|Ages||18 Years to 67 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00021138|
|Other Study ID Numbers ICMJE||PICS-R44-CA80525, CDR0000068751, NCI-V01-1662|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Personal Improvement Computer Systems|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||March 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP