Lung Cancer Clinical Trial
Official title:
International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study
Verified date | June 2015 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and
nicotine replacement therapy may be useful in helping smokers stop smoking.
PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to
cigarettes.
Status | Completed |
Enrollment | 67 |
Est. completion date | November 2011 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Currently smokes = 10 cigarettes per day - Not planning to quit smoking in the next 30 days and has not tried to quit in the past 30 days - Medically eligible to receive nicotine-replacement products, based on the NYS Smokers Quitline eligibility criteria PATIENT CHARACTERISTICS: - Not pregnant or nursing - Able to read and speak English - In good general health - No history of heart attack or stroke in the past 2 weeks - No history of chest pains in the past month - No report of physician-diagnosed arrhythmia/irregular heartbeat or use of pacemaker - No report of physician-diagnosed heart disease/coronary artery disease, uncontrolled hypertension, stomach ulcer, diabetes, depression, or asthma PRIOR CONCURRENT THERAPY: - No other concurrent tobacco products or nicotine medications - No concurrent Zyban, Bupropion, Wellbutrin, Chantix, or other smoking cessation medication |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of participants with no interest in trial of harm-reduction products (HRPs) | A 10-15 minute web-based survey on a computer | No | |
Primary | Percent of participants willing to try HRPs | A 10-15 minute web-based survey on a computer | No | |
Primary | Percent of participants that completed 1-week trial | One week | No | |
Primary | Percent of participants willing to continue with preferred HRP | 6 months follow up | No |
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