Status:
TERMINATED
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized clinical trial studies interest in smokeless tobacco product as a substitution for cigarettes in current smokers. Use of smokeless tobacco products may help people stop smoking. Measur...
Detailed Description
PRIMARY OBJECTIVES: I. Systematically vary price, availability, product type, and information about products to examine their individual and joint effects on degree of substitution of smokeless produ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Must report currently smoke at least 10 cigarettes per day and been smoking for at least 1 year
- Must not be planning to quit smoking in the next 30 days, nor tried to quit in the last 30 days
- Must be able to read and speak English
- Should not concurrently using other tobacco products or nicotine medications
- Willing to try new tobacco products and substitute other brands of cigarettes
- Not current participating in any other ongoing research study
- Must be in good general health
- Medically eligible to receive nicotine replacement products (based upon the New York State \[NYS\] Smokers Quit line eligibility criteria)
- No history of heart attack or stoke in last 2 weeks
- No current use of Zyban, bupropion, Wellbutrin, or Chantix/varenicline, or other smoking cessation medication
- No history of chest pains or angina in past month
- No report of physician diagnosed arrhythmia/irregular heartbeat, fast heartbeat, abnormal heart rate, or use of pacemaker
- No current report of physician diagnosed heart disease/coronary artery disease, high blood pressure (systolic blood pressure \[SBP\] = 160; diastolic blood pressure \[DBP\] = 100), stomach ulcer, diabetes, or taking pills for depression or asthma
- No self-reported chronic dental problems that would interfere with using oral products
- No use of an electronic cigarette (e-cigarette) in the past 30 days
- No known sensitivity to glycerol, propylene glycol, or glycerin
- For females, not currently pregnant or breastfeeding; nor planning to become pregnant during the follow-up interval
- Prospective participants must also pass screening tests for substance use, administered at the orientation session, to be entered on study; substance use will be assessed using a Clinical Laboratory Improvement Amendments (CLIA)-waived 7-drug urine screen (detecting presence of tetrahydrocannabinol \[THC\], opiates, amphetamine, barbiturates, methamphetamine, phencyclidine \[PCP\], and lysergic acid diethylamide \[LSD\]); participants must test negative on all 7 to be put on study
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01800500
Start Date
September 1 2011
Last Update
September 13 2022
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263