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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00021138
First received: July 11, 2001
Last updated: May 14, 2013
Last verified: March 2011
  Purpose

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
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Behavioral: smoking cessation intervention
Drug: nicotine

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Computerized Scheduling of Nicotine Inhaler Use

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2001
Study Completion Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021138

Locations
United States, Virginia
Personal Improvement Computer Systems, Incorporated
Reston, Virginia, United States, 20191
Sponsors and Collaborators
Personal Improvement Computer Systems
Investigators
Study Chair: William Riley, PhD Personal Improvement Computer Systems
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00021138     History of Changes
Other Study ID Numbers: PICS-R44-CA80525, CDR0000068751, NCI-V01-1662
Study First Received: July 11, 2001
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

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:
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014