Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers

Not Applicable

Terminated

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: smoking cessation intervention; Other: questionnaire administration; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Other: ecigarettes

• Registration Number: NCT01800500
• Lead Sponsor: Roswell Park Cancer Institute

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. 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

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 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-27
• Primary Completion: 2015-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (fixed rate ST product prices)	smoking cessation intervention	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 I (fixed rate ST product prices)	ecigarettes	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 (escalating ST product prices)	ecigarettes	Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
Arm I (fixed rate ST product prices)	questionnaire administration	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 (escalating ST product prices)	smoking cessation intervention	Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
Arm I (fixed rate ST product prices)	quality-of-life assessment	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 (escalating ST product prices)	questionnaire administration	Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
Arm I (fixed rate ST product prices)	laboratory biomarker analysis	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 (escalating ST product prices)	quality-of-life assessment	Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
Arm II (escalating ST product prices)	laboratory biomarker analysis	Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of group members that replace at least 50% of baseline cigarette consumption with ST	Up to week 5	Assessed using a Fisher's exact test.
Change in saliva cotinine	Up to week 5	Tested using hierarchical linear modeling and generalized estimating equations.
Proportion of tobacco use accounted for by ST	Up to week 5	Tested using hierarchical linear modeling and generalized estimating equations.
Change in exhaled alveolar CO	Up to week 5	Tested using hierarchical linear modeling and generalized estimating equations.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States