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Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking

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ClinicalTrials.gov Identifier: NCT00021138
Recruitment Status : Completed
First Posted : March 19, 2004
Last Update Posted : May 15, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
Esophageal Cancer Head and Neck Cancer Lung Cancer Behavioral: smoking cessation intervention Drug: nicotine

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Computerized Scheduling of Nicotine Inhaler Use
Study Start Date : April 2001
Study Completion Date : March 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Personal Improvement Computer Systems
Study Chair: William Riley, PhD Personal Improvement Computer Systems

ClinicalTrials.gov Identifier: NCT00021138     History of Changes
Other Study ID Numbers: PICS-R44-CA80525
CDR0000068751 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 19, 2004    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: March 2011

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Head and Neck Neoplasms
Esophageal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action