- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02061917
Switching From Usual Brand Cigarettes to a Tobacco-heating Cigarette or Snus (QoL)
February 15, 2016 updated by: R.J. Reynolds Tobacco Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
163
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Daytona, Florida, United States, 32117
- Covance Clinical Research Unit, Inc.
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Idaho
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Boise, Idaho, United States, 83704
- Covance Clinical Research Unit, Inc.
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Oregon
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Portland, Oregon, United States, 97239
- Covance Clinical Research Unit, Inc.
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Texas
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Austin, Texas, United States, 78752
- Covance Clinical Research Unit, Inc.
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Dallas, Texas, United States, 75247
- Covance Clinical Research Unit, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tobacco-Heating Cigarette
A group of 44 subjects who smoke and are switched to a 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)
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Smokers switched to snus product for 24 weeks
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Experimental: Tobacco-Burning Cigarette
A group of 44 subjects who smoke and are switched to a tobacco-burning ultra-low machine yield cigarette
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Smokers switched to a tobacco-burning cigarette for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12
Time Frame: Week 12
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Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity
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Week 12
|
Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12
Time Frame: Week 12
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Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin
|
Week 12
|
Change in Markers of Exposure and Potential Harm from Weeks 0 to 12
Time Frame: Week 12
|
Exhaled carbon monoxide and spirometry
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Week 12
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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
|
Week 12
|
Change in tobacco usage diary from Weeks 0 to 4
Time Frame: Week 4
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Week 4
|
|
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
|
Week 24
|
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
|
Week 24
|
Change in Markers of Exposure and Potential Harm from Weeks 0 to 24
Time Frame: Week 24
|
Exhaled carbon monoxide and spirometry
|
Week 24
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Change in daily tobacco usage diary from Weeks 4 to 8
Time Frame: Week 8
|
Week 8
|
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Change in daily tobacco usage diary from Weeks 8 to 12
Time Frame: Week 12
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Week 12
|
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Change in daily tobacco usage diary from Weeks 12 to 16
Time Frame: Week 16
|
Week 16
|
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Change in daily tobacco usage diary from Weeks 16 to 20
Time Frame: Week 20
|
Week 20
|
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Change in daily tobacco usage diary from Weeks 20 to 24
Time Frame: Week 24
|
Week 24
|
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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
|
Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Nicotine Yield versus Uptake from Weeks 0 to 12
Time Frame: Week 12
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Mouth-level exposure to tar and nicotine
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Week 12
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Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 12
Time Frame: Week 12
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Smoking Cessation Quality of Life Questionnaire (inclusive of the SF-36 v2)
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Week 12
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Change in Nicotine Yield versus Uptake from Weeks 0 to 24
Time Frame: Week 24
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Mouth-level exposure to tar and nicotine
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Week 24
|
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)
|
Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael W Ogden, Ph.D., R.J. Reynolds Tobacco Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
February 5, 2014
First Submitted That Met QC Criteria
February 11, 2014
First Posted (Estimate)
February 13, 2014
Study Record Updates
Last Update Posted (Estimate)
February 17, 2016
Last Update Submitted That Met QC Criteria
February 15, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSD-0702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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