Esophageal CancerNCT00021138
Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking
A study testing smoking cessation intervention and nicotine in people with Esophageal Cancer and Head and Neck Cancer, run by Personal Improvement Computer Systems at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Esophageal Cancer, Head and Neck Cancer, Lung Cancer
- What is being tested?
- smoking cessation intervention and nicotine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Personal Improvement Computer Systems, Incorporated
Reston, Virginia, 20191
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Cancer, Head and Neck Cancer, Lung Cancer
- Being tested
- smoking cessation intervention, nicotine
- 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
- Medical subject headings
- Esophageal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation interventionBehavioural
nicotineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2004 (estimated)
- Study startApr 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Personal Improvement Computer Systems
- Sponsor type
- University, hospital or other
- Investigators
- William Riley, PhD, Study chair, Personal Improvement Computer Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021138
- Sponsor's protocol ID
- PICS-R44-CA80525
- Other IDs
- CDR0000068751, NCI-V01-1662
- Status last verified
- Mar 2011
- First submitted
- 11 Jul 2001
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Scheduling of Nicotine Inhaler Use
- ClinicalTrials.gov ID
- NCT00021138
- Acronym / sponsor ID
- PICS-R44-CA80525
- Conditions
- Esophageal Cancer, Head and Neck Cancer, Lung Cancer
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Personal Improvement Computer SystemsUniversity, hospital or other
- Study start
- Apr 2001
- Study completion
- Mar 2004 (actual)
- First posted
- 19 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking cessation intervention | Behavioural | – |
| nicotine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Riley, PhD study chair
Personal Improvement Computer Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation intervention and nicotine in people with Esophageal Cancer and Head and Neck Cancer, run by Personal Improvement Computer Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.