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

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

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

Study Overview

• Status: Terminated
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: questionnaire administration; Other: quality-of-life assessment; Behavioral: smoking cessation intervention; Behavioral: smoking cessation intervention; Other: ecigarettes; Other: ecigarettes

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (fixed rate ST product prices); 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	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Behavioral: smoking cessation intervention; Purchase ST products using a fixed rate of product prices; Behavioral: smoking cessation intervention; Purchase ST products using escalating product prices; Other: ecigarettes; Purchase ST products using escalating product prices nicotine replacement therapy; Other Names: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus,NRT; Other: ecigarettes; Purchase ST products using a fixed rate of product prices nicotine replacement therapy; Other Names: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus, NRT
Experimental: Arm II (escalating ST product prices); Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Behavioral: smoking cessation intervention; Purchase ST products using a fixed rate of product prices; Behavioral: smoking cessation intervention; Purchase ST products using escalating product prices; Other: ecigarettes; Purchase ST products using escalating product prices nicotine replacement therapy; Other Names: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus,NRT; Other: ecigarettes; Purchase ST products using a fixed rate of product prices nicotine replacement therapy; Other Names: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus, NRT

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: I 165309; NCI-2013-00403 (Registry Identifier: CTRP (Clinical Trial Reporting Program))