Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
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. Measuring use of other sources of nicotine for cigarettes under a
 variety of different conditions may help determine whether and how much smokers are willing
 to use substitutions
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 products
 for cigarettes.

 II. Examine the impact of smokeless tobacco (ST) substitution on biomarkers of exposure
 (carbon monoxide [CO], cotinine).

 III. Explore relationships between ST substitution and measures of mood and health related
 quality of life.

 OUTLINE: Participants are randomized to 1 of 2 treatment arms.

 ARM I: Participants purchase ST products using a fixed rate of product prices once weekly and
 record their consumption of ST products and cigarettes smoked daily for 3 weeks.

 ARM II: Participants purchase ST products using escalating product prices once weekly and
 record their consumption of ST products and cigarettes smoked daily for 3 weeks.

 After completion of study treatment, patients are followed up for 6 months.
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