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

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ClinicalTrials.gov Identifier: NCT02061917
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
Analytisch-biologisches Forschungslabor GmbH
Arista Laboratories
Covance
Covance IVRS
Pacific Biomarkers
University of Louisville
Information provided by (Responsible Party):
R.J. Reynolds Tobacco Company

Brief 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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Other: Tobacco-Heating Cigarette Other: Snus (Smokeless Tobacco) Other: Tobacco-Burning Cigarette Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switching From Usual Brand Cigarettes to a Tobacco-heating Cigarette or Snus - A Multi-center Evaluation of Health-related Quality of Life Assessments and Biomarkers of Exposure and Harm
Study Start Date : February 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: Tobacco-Heating Cigarette
A group of 44 subjects who smoke and are switched to a tobacco-heating cigarette
Other: Tobacco-Heating Cigarette
Smokers switched to a tobacco-heating cigarette for 24 weeks

Experimental: Snus (Smokeless Tobacco)
A group of 43 subjects who smoke and are switched to snus (smokeless tobacco)
Other: Snus (Smokeless Tobacco)
Smokers switched to snus product for 24 weeks

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
Smokers switched to a tobacco-burning cigarette for 24 weeks




Primary Outcome Measures :
  1. Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12 [ Time Frame: Week 12 ]
    Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity

  2. Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12 [ Time Frame: Week 12 ]
    Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin

  3. Change in Markers of Exposure and Potential Harm from Weeks 0 to 12 [ Time Frame: Week 12 ]
    Exhaled carbon monoxide and spirometry

  4. Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 12 [ Time Frame: Week 12 ]
    St. George's Respiratory Questionnaire and Leicester Cough Questionnaire

  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 [ Time Frame: Week 24 ]
    Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity

  7. Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24 [ Time Frame: Week 24 ]
    Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin

  8. Change in Markers of Exposure and Potential Harm from Weeks 0 to 24 [ Time Frame: Week 24 ]
    Exhaled carbon monoxide and spirometry

  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 [ Time Frame: Week 24 ]
    St. George's Respiratory Questionnaire and Leicester Cough Questionnaire


Secondary Outcome Measures :
  1. Change in Nicotine Yield versus Uptake from Weeks 0 to 12 [ Time Frame: Week 12 ]
    Mouth-level exposure to tar and nicotine

  2. Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 12 [ Time Frame: Week 12 ]
    Smoking Cessation Quality of Life Questionnaire (inclusive of the SF-36 v2)

  3. Change in Nicotine Yield versus Uptake from Weeks 0 to 24 [ Time Frame: Week 24 ]
    Mouth-level exposure to tar and nicotine

  4. Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 24 [ Time Frame: Week 24 ]
    Smoking Cessation Quality of Life Questionnaire (inclusive of the SF-36 v2)



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061917


Locations
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United States, Florida
Covance Clinical Research Unit, Inc.
Daytona, Florida, United States, 32117
United States, Idaho
Covance Clinical Research Unit, Inc.
Boise, Idaho, United States, 83704
United States, Oregon
Covance Clinical Research Unit, Inc.
Portland, Oregon, United States, 97239
United States, Texas
Covance Clinical Research Unit, Inc.
Austin, Texas, United States, 78752
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
R.J. Reynolds Tobacco Company
Analytisch-biologisches Forschungslabor GmbH
Arista Laboratories
Covance
Covance IVRS
Pacific Biomarkers
University of Louisville
Investigators
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Principal Investigator: Michael W Ogden, Ph.D. R.J. Reynolds Tobacco Company

Publications of Results:
Other Publications:
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Responsible Party: R.J. Reynolds Tobacco Company
ClinicalTrials.gov Identifier: NCT02061917     History of Changes
Other Study ID Numbers: HSD-0702
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by R.J. Reynolds Tobacco Company:
Biomarkers
Tobacco
Tobacco-heating
Smokeless Tobacco
Snus
Smoking
Exposure
Quality of Life
Additional relevant MeSH terms:
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Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents