Cigarette SmokingQoLNCT02061917
Switching From Usual Brand Cigarettes to a Tobacco-heating Cigarette or Snus
A study testing Tobacco-Heating Cigarette, Snus (Smokeless Tobacco) and Tobacco-Burning Cigarette in people with Cigarette Smoking, run by R.J. Reynolds Tobacco Company at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 28 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Tobacco-Heating Cigarette, Snus (Smokeless Tobacco) and Tobacco-Burning Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Covance Clinical Research Unit, Inc.
Austin, Texas, 78752
Covance Clinical Research Unit, Inc.
Boise, Idaho, 83704
Covance Clinical Research Unit, Inc.
Dallas, Texas, 75247
Covance Clinical Research Unit, Inc.
Daytona Beach, Florida, 32117
Covance Clinical Research Unit, Inc.
Portland, Oregon, 97239
About this study
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
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.
- Conditions
- Cigarette Smoking
- Being tested
- Tobacco-Heating Cigarette, Snus (Smokeless Tobacco), Tobacco-Burning Cigarette
- Keywords
- Biomarkers, Tobacco, Tobacco-heating, Smokeless Tobacco, Snus, Smoking, Exposure, Quality of Life
- Medical subject headings
- Cigarette Smoking, Tobacco Use, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco-Heating CigaretteOther
Smokers switched to a tobacco-heating cigarette for 24 weeks
Snus (Smokeless Tobacco)Other
Smokers switched to snus product for 24 weeks
Tobacco-Burning CigaretteOther
Smokers switched to a tobacco-burning cigarette for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tobacco-Heating Cigarette | Experimental | A group of 44 subjects who smoke and are switched to a tobacco-heating cigarette Receives: Other: Tobacco-Heating Cigarette |
| Snus (Smokeless Tobacco) | Experimental | A group of 43 subjects who smoke and are switched to snus (smokeless tobacco) Receives: Other: Snus (Smokeless Tobacco) |
| Tobacco-Burning Cigarette | Experimental | A group of 44 subjects who smoke and are switched to a tobacco-burning ultra-low machine yield cigarette Receives: Other: Tobacco-Burning Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12
Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin
Measured: Week 12
Change in Markers of Exposure and Potential Harm from Weeks 0 to 12
Exhaled carbon monoxide and spirometry
Measured: Week 12
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
Measured: Week 12
Change in tobacco usage diary from Weeks 0 to 4
Measured: Week 4
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
Measured: Week 24
Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24
Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin
Measured: Week 24
Change in Markers of Exposure and Potential Harm from Weeks 0 to 24
Exhaled carbon monoxide and spirometry
Measured: Week 24
Change in daily tobacco usage diary from Weeks 4 to 8
Measured: Week 8
Change in daily tobacco usage diary from Weeks 8 to 12
Measured: Week 12
Change in daily tobacco usage diary from Weeks 12 to 16
Measured: Week 16
Change in daily tobacco usage diary from Weeks 16 to 20
Measured: Week 20
Change in daily tobacco usage diary from Weeks 20 to 24
Measured: Week 24
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
Measured: Week 24
Secondary outcomes (4)
Change in Nicotine Yield versus Uptake from Weeks 0 to 12
Mouth-level exposure to tar and nicotine
Measured: Week 12
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)
Measured: Week 12
Change in Nicotine Yield versus Uptake from Weeks 0 to 24
Mouth-level exposure to tar and nicotine
Measured: Week 24
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)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- R.J. Reynolds Tobacco Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analytisch-biologisches Forschungslabor GmbH, Arista Laboratories, Covance, Covance IVRS, Pacific Biomarkers, University of Louisville
- Responsible party
- Sponsor
- Investigators
- Michael W Ogden, Ph.D., Principal investigator, R.J. Reynolds Tobacco Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061917
- Sponsor's protocol ID
- HSD-0702
- Acronym
- QoL
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 26525849Ogden 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 26554277Ogden 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02061917
- Acronym / sponsor ID
- QoL / HSD-0702
- Conditions
- Cigarette Smoking
- Keywords
- Biomarkers, Tobacco, Tobacco-heating, Smokeless Tobacco, Snus, Smoking, Exposure, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- R.J. Reynolds Tobacco CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Analytisch-biologisches Forschungslabor GmbH, Arista Laboratories, Covance, Covance IVRS, Pacific Biomarkers, University of Louisville
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tobacco-Heating Cigarette | Experimental | Other: Tobacco-Heating CigaretteA group of 44 subjects who smoke and are switched to a tobacco-heating cigarette |
| Snus (Smokeless Tobacco) | Experimental | Other: Snus (Smokeless Tobacco)A group of 43 subjects who smoke and are switched to snus (smokeless tobacco) |
| Tobacco-Burning Cigarette | Experimental | Other: Tobacco-Burning CigaretteA group of 44 subjects who smoke and are switched to a tobacco-burning ultra-low machine yield cigarette |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco-Heating CigaretteSmokers switched to a tobacco-heating cigarette for 24 weeks | Other | Tobacco-Heating Cigarette |
| Snus (Smokeless Tobacco)Smokers switched to snus product for 24 weeks | Other | Snus (Smokeless Tobacco) |
| Tobacco-Burning CigaretteSmokers switched to a tobacco-burning cigarette for 24 weeks | Other | Tobacco-Burning Cigarette |
Primary outcome
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
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
Change in Markers of Exposure and Potential Harm from Weeks 0 to 12
Time frame: Week 12
Exhaled carbon monoxide and spirometry
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
Change in tobacco usage diary from Weeks 0 to 4
Time frame: 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
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
Change in Markers of Exposure and Potential Harm from Weeks 0 to 24
Time frame: Week 24
Exhaled carbon monoxide and spirometry
Change in daily tobacco usage diary from Weeks 4 to 8
Time frame: Week 8
Change in daily tobacco usage diary from Weeks 8 to 12
Time frame: Week 12
Change in daily tobacco usage diary from Weeks 12 to 16
Time frame: Week 16
Change in daily tobacco usage diary from Weeks 16 to 20
Time frame: Week 20
Change in daily tobacco usage diary from Weeks 20 to 24
Time frame: Week 24
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
4 secondary outcomes
Change in Nicotine Yield versus Uptake from Weeks 0 to 12
Time frame: Week 12
Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 12
Time frame: Week 12
Change in Nicotine Yield versus Uptake from Weeks 0 to 24
Time frame: Week 24
Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 24
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Background: PubMed 26525849Ogden 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.
- Results publication: PubMed 26554277Ogden 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.
- Results publication: PubMed 26525962Ogden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W Ogden, Ph.D. principal investigator
R.J. Reynolds Tobacco Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco-Heating Cigarette, Snus (Smokeless Tobacco) and Tobacco-Burning Cigarette in people with Cigarette Smoking, run by R.J. Reynolds Tobacco Company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12 (time frame: Week 12). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061917, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.