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

Primary Purpose

Tobacco Use Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
smoking cessation intervention
smoking cessation intervention
questionnaire administration
quality-of-life assessment
laboratory biomarker analysis
ecigarettes
ecigarettes
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (fixed rate ST product prices)

Arm II (escalating ST product prices)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 20, 2013
Last Updated
September 8, 2022
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01800500
Brief Title
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
Official Title
Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty accruing
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (fixed rate ST product prices)
Arm Type
Experimental
Arm Description
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 Title
Arm II (escalating ST product prices)
Arm Type
Experimental
Arm Description
Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation intervention
Intervention Description
Purchase ST products using a fixed rate of product prices
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation intervention
Intervention Description
Purchase ST products using escalating product prices
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
ecigarettes
Other Intervention Name(s)
ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus,NRT
Intervention Description
Purchase ST products using escalating product prices nicotine replacement therapy
Intervention Type
Other
Intervention Name(s)
ecigarettes
Other Intervention Name(s)
ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus, NRT
Intervention Description
Purchase ST products using a fixed rate of product prices nicotine replacement therapy
Primary Outcome Measure Information:
Title
Proportion of tobacco use accounted for by ST
Description
Tested using hierarchical linear modeling and generalized estimating equations.
Time Frame
Up to week 5
Title
Proportion of group members that replace at least 50% of baseline cigarette consumption with ST
Description
Assessed using a Fisher's exact test.
Time Frame
Up to week 5
Title
Change in saliva cotinine
Description
Tested using hierarchical linear modeling and generalized estimating equations.
Time Frame
Up to week 5
Title
Change in exhaled alveolar CO
Description
Tested using hierarchical linear modeling and generalized estimating equations.
Time Frame
Up to week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Mahoney
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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