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Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes


N/A
18 Years
N/A
Open (Enrolling)
Both
Tobacco Use Disorder

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Trial Information

Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Proportion of tobacco use accounted for by ST

Outcome Description:

Tested using hierarchical linear modeling and generalized estimating equations.

Outcome Time Frame:

Up to week 5

Safety Issue:

No

Principal Investigator

Martin Mahoney

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

I 165309

NCT ID:

NCT01800500

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Tobacco Use Disorder
  • Tobacco Use Disorder

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263