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CompletedNCT02061917QoLUpdated Feb 17, 2016

Switching From Usual Brand Cigarettes to a Tobacco-heating Cigarette or Snus

An interventional study of Tobacco-Heating Cigarette and Snus (Smokeless Tobacco) in Cigarette Smoking, sponsored by R.J. Reynolds Tobacco Company. Completed at 5 sites in United States. Open to participants aged 28 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-17.

Sponsored by R.J. Reynolds Tobacco Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
28 Years to 55 Years
Sex
All
01

Study summary

To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess quality of life measures in smokers randomly switched from their usual brand of cigarette to one of three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco); or (3) an ultra-low machine yield tobacco-burning cigarette.

Read the detailed description

A randomized, multi-center, 4-group study of health status measures and biomarkers in subjects who smoke and are switched to either a tobacco-heating cigarette, snus, or a tobacco-burning cigarette, with a non-treatment group of never-smokers.

Primary Objectives:

  • Evaluate select biomarkers of tobacco exposure and biomarkers of harm from subjects who smoke and who are switched to a tobacco-heating cigarette, snus, or a tobacco-burning cigarette.
  • Evaluate ability of a tobacco-heating cigarette and snus to modify patient-reported Chronic Obstructive Pulmonary Disease (COPD)-related health status in subjects who smoke and are switched to either a tobacco-heating cigarette or snus relative to a control group (a tobacco-burning ultra-low machine yield [ULMY]) cigarette.
  • Assess subject compliance.

Secondary Objectives:

  • Measure amount and repeatability of smoke components yielded from the cigarettes (yield in use) and determine relative uptake of selected smoke components.
  • Evaluate the ability of a tobacco-heating cigarette and snus to modify general health status as measured by self-administered health questionnaires in subjects who smoke and are switched to either a tobacco-heating cigarette or snus relative to a control group (a tobacco-burning ULMY cigarette).
  • Compare health status measures in smokers who are switched to a tobacco-heating cigarette to smokers who are switched to snus.
  • Compare baseline data from all tobacco-using groups to baseline data from the never-smoking (non-treatment) group.
02

Conditions studied

  • Cigarette Smoking

Keywords

  • Biomarkers
  • Tobacco
  • Tobacco-heating
  • Smokeless Tobacco
  • Snus
  • Smoking
  • Exposure
  • Quality of Life
03

In context

Lead sponsor

R.J. Reynolds Tobacco Company is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males or females, between 28 and 55 years of age, inclusive.
  • Cigarette-only smokers who currently smoked at least 15 cigarettes daily and who smoked for at least 10 years prior to Week 0 (i.e., chronic cigarette smokers).
  • Smokers not intending to quit smoking, but willing to switch their tobacco product (intent to quit was defined as intending to make or making a quit attempt within 1 month prior to Week 0).
  • Non-smoking subjects who self-reported "Never-Smoker" per the American Thoracic Society Questionnaire definition, and did not have urinary cotinine levels exceeding 50 ng/mL.
  • Subjects, in the opinion of the Investigators, free of clinically significant health problems and not on medication on a daily basis for chronic medical disorders deemed clinically significant by the Investigator(s).
  • Subjects not regularly taking creatine supplements.
  • Subjects testing negative for selected drugs of abuse at Screening (included alcohol test).
  • Subjects with a negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative Human Immunodeficiency Virus (HIV) antibody screens (for subjects immunized against hepatitis B with documentation of this immunization, a positive test result was not exclusionary).
  • Female subjects who were non-pregnant (urine pregnancy test results were negative at Screening and Weeks 0, 12, and 24), non-lactating, and either postmenopausal (as verified by Follicle Stimulating Hormone levels) for at least 1 year, surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days, or agreed to use from the time of signing the informed consent until 30 days after Week 24 (or Study Completion) a form of contraception considered acceptable to the Investigators (such as oral, injectable or implantable contraceptives, intrauterine devices and barrier methods ).
  • Subjects able to read and comprehend questionnaires in English and willing to sign an Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

  • Smokers using any other tobacco or nicotine-containing product or device other than tobacco-burning cigarettes from 6 months prior to the study through Week 24, including cigars, pipes, chewing tobacco, snuff, snus, nicotine patch, nicotine gum, etc.
  • A history or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders.
  • A history of hypersensitivity or allergies to any drug compound unless approved by the Investigator(s).
  • A history or presence of an abnormal ECG deemed clinically significant by the Investigator.
  • A history of alcoholism or drug addiction within 1 year prior to Study Entry.
  • Evidence of visible oral cancer, as found in an oral health examination or based on oral health questions at each visit.
  • Any acute or chronic condition that, in the Investigator(s)' opinion, limited the subject's ability to complete and/or participate in the study.
  • Donation of blood from 30 days prior to Screening through Week 24 (or Study Completion), inclusive, or plasma from 2 weeks prior to Screening through Week 24 (or Study Completion), inclusive.
  • Receipt of blood products within 2 months prior to Study Entry.
  • Subject or a relative of the subject was currently or had ever been employed by the tobacco industry.
  • Subject participated in any other investigational study drug or product trial in which receipt of an investigational study drug or product occurred within 30 days prior to Check-in (inclusive).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
163 participants (actual)

Study arms

  • Experimental
    Tobacco-Heating Cigarette

    A group of 44 subjects who smoke and are switched to a tobacco-heating cigarette

    Other: Tobacco-Heating Cigarette

  • Experimental
    Snus (Smokeless Tobacco)

    A group of 43 subjects who smoke and are switched to snus (smokeless tobacco)

    Other: Snus (Smokeless Tobacco)

  • Experimental
    Tobacco-Burning Cigarette

    A group of 44 subjects who smoke and are switched to a tobacco-burning ultra-low machine yield cigarette

    Other: Tobacco-Burning Cigarette

Interventions

  • OtherTobacco-Heating Cigarette

    Smokers switched to a tobacco-heating cigarette for 24 weeks

  • OtherSnus (Smokeless Tobacco)

    Smokers switched to snus product for 24 weeks

  • OtherTobacco-Burning Cigarette

    Smokers switched to a tobacco-burning cigarette for 24 weeks

06

What researchers measure

Primary outcomes

  1. Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12

    Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity

    Time frame: Week 12

  2. Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12

    Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin

    Time frame: Week 12

  3. Change in Markers of Exposure and Potential Harm from Weeks 0 to 12

    Exhaled carbon monoxide and spirometry

    Time frame: Week 12

  4. Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 12

    St. George's Respiratory Questionnaire and Leicester Cough Questionnaire

    Time frame: Week 12

  5. Change in tobacco usage diary from Weeks 0 to 4

    Time frame: Week 4

  6. Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 24

    Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity

    Time frame: Week 24

  7. Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24

    Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin

    Time frame: Week 24

  8. Change in Markers of Exposure and Potential Harm from Weeks 0 to 24

    Exhaled carbon monoxide and spirometry

    Time frame: Week 24

  9. Change in daily tobacco usage diary from Weeks 4 to 8

    Time frame: Week 8

  10. Change in daily tobacco usage diary from Weeks 8 to 12

    Time frame: Week 12

  11. Change in daily tobacco usage diary from Weeks 12 to 16

    Time frame: Week 16

  12. Change in daily tobacco usage diary from Weeks 16 to 20

    Time frame: Week 20

  13. Change in daily tobacco usage diary from Weeks 20 to 24

    Time frame: Week 24

  14. Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 24

    St. George's Respiratory Questionnaire and Leicester Cough Questionnaire

    Time frame: Week 24

Secondary outcomes

  1. Change in Nicotine Yield versus Uptake from Weeks 0 to 12

    Mouth-level exposure to tar and nicotine

    Time frame: Week 12

  2. Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 12

    Smoking Cessation Quality of Life Questionnaire (inclusive of the SF-36 v2)

    Time frame: Week 12

  3. Change in Nicotine Yield versus Uptake from Weeks 0 to 24

    Mouth-level exposure to tar and nicotine

    Time frame: Week 24

  4. Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 24

    Smoking Cessation Quality of Life Questionnaire (inclusive of the SF-36 v2)

    Time frame: Week 24

07

Study locations

5 sites
  • Covance Clinical Research Unit, Inc.
    Daytona, Florida 32117, United States
  • Covance Clinical Research Unit, Inc.
    Boise, Idaho 83704, United States
  • Covance Clinical Research Unit, Inc.
    Portland, Oregon 97239, United States
  • Covance Clinical Research Unit, Inc.
    Austin, Texas 78752, United States
  • Covance Clinical Research Unit, Inc.
    Dallas, Texas 75247, United States
08

References and documents

Publications

  • Ogden MW, Marano KM, Jones BA, Stiles MF. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology. Biomarkers. 2015;20(6-7):382-90. doi: 10.3109/1354750X.2015.1094133. Epub 2015 Nov 2. PubMed 26525849 ↗
  • Ogden MW, Marano KM, Jones BA, Morgan WT, Stiles MF. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 2. Biomarkers of exposure. Biomarkers. 2015;20(6-7):391-403. doi: 10.3109/1354750X.2015.1094134. Epub 2015 Nov 10. PubMed 26554277 ↗
  • Ogden MW, Marano KM, Jones BA, Morgan WT, Stiles MF. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect. Biomarkers. 2015;20(6-7):404-10. doi: 10.3109/1354750X.2015.1094135. Epub 2015 Nov 2. PubMed 26525962 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02061917
Lead sponsor
R.J. Reynolds Tobacco Company
Collaborators
Analytisch-biologisches Forschungslabor GmbH, Arista Laboratories, Covance, Covance IVRS, Pacific Biomarkers, University of Louisville
Responsible party
Sponsor
First posted
Feb 13, 2014
Start date
Feb 2007
Primary completion
Nov 2007
Completion
Nov 2009
Last update
Feb 17, 2016

Study contacts

Michael W Ogden, Ph.D.
principal investigator · R.J. Reynolds Tobacco Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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