Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking
Condition: Esophageal Cancer; Head and Neck Cancer; Lung Cancer
MeSH terms: Lung Neoplasms; Esophageal Neoplasms
Study type: Interventional

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.
    

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.
    

Intervention name(s): smoking cessation intervention; nicotine
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Nicotine
Primary purpose: Prevention
Keywords: non-small cell lung cancer; small cell lung cancer; esophageal cancer; hypopharyngeal cancer; laryngeal cancer; nasopharyngeal cancer; oropharyngeal cancer; lip and oral cavity cancer; paranasal sinus and nasal cavity cancer; tongue cancer