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Sponsored by: |
Personal Improvement Computer Systems |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021138 |
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 | Intervention |
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Esophageal Cancer Head and Neck Cancer Lung Cancer |
Behavioral: smoking cessation intervention Drug: nicotine |
Study Type: | Interventional |
Study Design: | Prevention |
Official Title: | Computerized Scheduling of Nicotine Inhaler Use |
Study Start Date: | April 2001 |
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.
Ages Eligible for Study: | 18 Years to 67 Years |
Genders Eligible for Study: | Both |
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
United States, Virginia | |
Personal Improvement Computer Systems, Incorporated | |
Reston, Virginia, United States, 20191 |
Study Chair: | William Riley, PhD | Personal Improvement Computer Systems |
Study ID Numbers: | CDR0000068751, PICS-R44-CA80525, NCI-V01-1662 |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00021138 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Thoracic Neoplasms Nicotine polacrilex Neurotransmitter Agents Gastrointestinal Diseases Laryngeal Carcinoma Nicotinic Agonists Esophageal Neoplasms Cholinergic Agents Hypopharyngeal Cancer Lip and Oral Cavity Cancer Smoking Respiratory Tract Diseases Lung Neoplasms Nicotine Digestive System Neoplasms |
Nasopharyngeal Carcinoma Central Nervous System Stimulants Laryngeal Neoplasms Esophageal Cancer Oral Cancer Carcinoma, Small Cell Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Lung Diseases Gastrointestinal Neoplasms Non-small Cell Lung Cancer Peripheral Nervous System Agents Esophageal Diseases Carcinoma, Non-Small-Cell Lung |
Thoracic Neoplasms Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Gastrointestinal Diseases Esophageal Neoplasms Nicotinic Agonists Physiological Effects of Drugs Cholinergic Agents Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Nicotine Therapeutic Uses |
Ganglionic Stimulants Respiratory Tract Neoplasms Digestive System Neoplasms Central Nervous System Stimulants Pharmacologic Actions Neoplasms Digestive System Diseases Autonomic Agents Lung Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Peripheral Nervous System Agents Central Nervous System Agents |