SmokingNCT00812279
Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article
A study testing Distillation based smoking article (SMAR cigarette), conventional cigarette and smoking cessation in people with Smoking, run by Philip Morris Products S.A. at 1 site in Poland.
Trial summary
The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the SMAR cigarette. Read more about this study
- Who is it for?
- Ages 23 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Distillation based smoking article (SMAR cigarette), conventional cigarette and smoking cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2008to Feb 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 23 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian adult smokers (male and female), with acceptable health conditions, aged from 23 to 55 years who usually smoke 10 to 30 non-mentholated conventional cigarettes (with a maximum ISO tar yield of 10 mg) per day, for at least the last 5 consecutive years, will be enrolled in this study.
Who cannot join
- women of childbearing potential must be excluded if:Subject is pregnant (does not have negative pregnancy tests at screening and at D-2) or breastfeeding/ subject does not agree to use an acceptable method of effective contraception: intrauterine device, intrauterine system, established use of oral/injectable/implantable/ transdermal hormonal methods, barrier methods of contraception (condoms, occlusive caps) with spermicidal foam/gel/film/suppository, vasectomised partner or true abstinence (periodic abstinence and withdrawal are not effective methods) until the end of the safety follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled, Randomised, Open-label, 3-arm Parallel Single-centre Confinement Study to Investigate Exposure to Selected Smoke Constituents in Smokers Switching From Conventional Cigarettes to SMAR Cigarettes for 5 Days
The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the SMAR cigarette.
The main objective of this study is to compare the biomarkers of exposure to cigarette smoke constituents in smokers switching to SMAR and to biomarkers in smokers of conventional cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5 days. The short term safety of this new product will also be evaluated.
Read the detailed description
This is a controlled, randomised, open-label, 3-arm parallel single centre confinement study to investigate exposure to selected smoke constituents in smokers switching from CC to SMAR for 5 days.
112 eligible subjects will be randomised to the 3 study arms: SMAR, conventional cigarettes (CC) and smoking cessation (SC) in a 2:1:1 ratio.
Following the screening visit (within 4 weeks prior to the day of admission), the study will be run over an 8-day period in a confined environment, consisting of the admission day (D-2), a 2-day baseline period (D-1 and D0), and a 5-day exposure period (D1 to D5). Subjects will be discharged in the morning of D6. From the discharge of the subject, a 7-day safety follow-up period will be carried out (until D13).
- Conditions
- Smoking
- Being tested
- Distillation based smoking article (SMAR cigarette), conventional cigarette, smoking cessation
- Keywords
- Smokers with acceptable health conditions
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distillation based smoking article (SMAR cigarette)Other
Subjects randomised to the SMAR arm will be trained by the site staff on the usage of SMAR and the corresponding lighter prior to smoking the first SMAR. Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times but have to request each SMAR from the site staff when they wish to smoke.
conventional cigaretteOther
Subjects randomised to the CC arm will continue to smoke their preferred CC brand during the exposure period. Subjects will be allowed to smoke without any limit on consumption during the designated smoking times but will have to request each CC from the site staff when they wish to smoke.
smoking cessationOther
Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation.
| Study group | Role | What they receive |
|---|---|---|
| 1. SMAR | Experimental | Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times. Receives: Other: Distillation based smoking article (SMAR cigarette) |
| 2 Conventional cigarette (CC) | Active comparator | Subjects will be allowed to smoke without any limit on consumption during the designated smoking times. Receives: Other: conventional cigarette |
| 3. smoking cessation (SC) | Active comparator | Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation. Receives: Other: smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a reduction in the three primary biomarkers of exposure: Carboxyhaemoglobin concentration in blood, Urinary excretion of S-phenylmercapturic acid and urinary excretion of NNAL and NNAL-glucuronides (total NNAL)
Measured: 5 days
Secondary outcomes (9)
To explore changes from baseline COHb, S-PMA, and total NNAL in the three study arms in the course of the study
Measured: 5 days
To explore changes from baseline in the three study arms with regard to urinary excretion of biomarkers of exposure to several other smoke constituents.
Measured: 5 days
To assess urinary excretion of nicotine and its five major nicotine metabolites in the three study arms
Measured: 5 days
To assess nicotine and cotinine concentrations in plasma in the three study arms To compare levels of all biomarkers of exposure in the SMAR arm to those in the smoking cessation (SC) arm
Measured: 5 days
To assess the mutagenicity potential in urine at the end of the study in the three study arms
Measured: 5 days
To monitor blood pressure, pulse rate, electrocardiogram, clinical laboratory parameters (standard clinical biochemistry, standard haematology and urine analysis), and adverse events
Measured: 5 days
To investigate craving and withdrawal symptoms as well as pulmonary symptoms in all three study arms by means of questionnaires
Measured: 5 days
To investigate change in cytochrome P450 1A2 (CYP1A2) activity from D0 to D5 in the three study arms
Measured: 5 days
To assess and compare human smoking topography (HST) in smokers before and after switching to SMAR
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katarzyna Jarus-Dziedzic, MD, Principal investigator, MTZ Clinical Research Inc (Warsaw, Poland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812279
- Sponsor's protocol ID
- YVD-CS01-EU
- Status last verified
- Nov 2019
- First submitted
- 19 Dec 2008
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ludicke F, Haziza C, Weitkunat R, Magnette J. Evaluation of Biomarkers of Exposure in Smokers Switching to a Carbon-Heated Tobacco Product: A Controlled, Randomized, Open-Label 5-Day Exposure Study. Nicotine Tob Res. 2016 Jul;18(7):1606-13. doi: 10.1093/ntr/ntw022. Epub 2016 Jan 27.
PubMed 26817490
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomised, Open-label, 3-arm Parallel Single-centre Confinement Study to Investigate Exposure to Selected Smoke Constituents in Smokers Switching From Conventional Cigarettes to SMAR Cigarettes for 5 Days
- ClinicalTrials.gov ID
- NCT00812279
- Acronym / sponsor ID
- YVD-CS01-EU
- Conditions
- Smoking
- Keywords
- Smokers with acceptable health conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 22 Dec 2008 (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.
The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the SMAR cigarette.
The main objective of this study is to compare the biomarkers of exposure to cigarette smoke constituents in smokers switching to SMAR and to biomarkers in smokers of conventional cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5 days. The short term safety of this new product will also be evaluated.
Detailed description
This is a controlled, randomised, open-label, 3-arm parallel single centre confinement study to investigate exposure to selected smoke constituents in smokers switching from CC to SMAR for 5 days.
112 eligible subjects will be randomised to the 3 study arms: SMAR, conventional cigarettes (CC) and smoking cessation (SC) in a 2:1:1 ratio.
Following the screening visit (within 4 weeks prior to the day of admission), the study will be run over an 8-day period in a confined environment, consisting of the admission day (D-2), a 2-day baseline period (D-1 and D0), and a 5-day exposure period (D1 to D5). Subjects will be discharged in the morning of D6. From the discharge of the subject, a 7-day safety follow-up period will be carried out (until D13).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. SMAR | Experimental | Other: Distillation based smoking article (SMAR cigarette)Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times. |
| 2 Conventional cigarette (CC) | Active comparator | Other: conventional cigaretteSubjects will be allowed to smoke without any limit on consumption during the designated smoking times. |
| 3. smoking cessation (SC) | Active comparator | Other: smoking cessationSubjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation. |
Who may qualify
- Ages
- 23 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Caucasian adult smokers (male and female), with acceptable health conditions, aged from 23 to 55 years who usually smoke 10 to 30 non-mentholated conventional cigarettes (with a maximum ISO tar yield of 10 mg) per day, for at least the last 5 consecutive years, will be enrolled in this study.
Key exclusion criteria (1 listed)
- women of childbearing potential must be excluded if:Subject is pregnant (does not have negative pregnancy tests at screening and at D-2) or breastfeeding/ subject does not agree to use an acceptable method of effective contraception: intrauterine device, intrauterine system, established use of oral/injectable/implantable/ transdermal hormonal methods, barrier methods of contraception (condoms, occlusive caps) with spermicidal foam/gel/film/suppository, vasectomised partner or true abstinence (periodic abstinence and withdrawal are not effective methods) until the end of the safety follow-up period.
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 |
|---|---|---|
| Distillation based smoking article (SMAR cigarette)Subjects randomised to the SMAR arm will be trained by the site staff on the usage of SMAR and the corresponding lighter prior to smoking the first SMAR. Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times but have to request each SMAR from the site staff when they wish to smoke. | Other | 1. SMAR |
| conventional cigaretteSubjects randomised to the CC arm will continue to smoke their preferred CC brand during the exposure period. Subjects will be allowed to smoke without any limit on consumption during the designated smoking times but will have to request each CC from the site staff when they wish to smoke. | Other | 2 Conventional cigarette (CC) |
| smoking cessationSubjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation. | Other | 3. smoking cessation (SC) |
Primary outcome
To demonstrate a reduction in the three primary biomarkers of exposure: Carboxyhaemoglobin concentration in blood, Urinary excretion of S-phenylmercapturic acid and urinary excretion of NNAL and NNAL-glucuronides (total NNAL)
Time frame: 5 days
9 secondary outcomes
To explore changes from baseline COHb, S-PMA, and total NNAL in the three study arms in the course of the study
Time frame: 5 days
To explore changes from baseline in the three study arms with regard to urinary excretion of biomarkers of exposure to several other smoke constituents.
Time frame: 5 days
To assess urinary excretion of nicotine and its five major nicotine metabolites in the three study arms
Time frame: 5 days
To assess nicotine and cotinine concentrations in plasma in the three study arms To compare levels of all biomarkers of exposure in the SMAR arm to those in the smoking cessation (SC) arm
Time frame: 5 days
To assess the mutagenicity potential in urine at the end of the study in the three study arms
Time frame: 5 days
To monitor blood pressure, pulse rate, electrocardiogram, clinical laboratory parameters (standard clinical biochemistry, standard haematology and urine analysis), and adverse events
Time frame: 5 days
To investigate craving and withdrawal symptoms as well as pulmonary symptoms in all three study arms by means of questionnaires
Time frame: 5 days
To investigate change in cytochrome P450 1A2 (CYP1A2) activity from D0 to D5 in the three study arms
Time frame: 5 days
To assess and compare human smoking topography (HST) in smokers before and after switching to SMAR
Time frame: 5 days
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 7 Nov 2019.
- Results publication: PubMed 26817490Ludicke F, Haziza C, Weitkunat R, Magnette J. Evaluation of Biomarkers of Exposure in Smokers Switching to a Carbon-Heated Tobacco Product: A Controlled, Randomized, Open-Label 5-Day Exposure Study. Nicotine Tob Res. 2016 Jul;18(7):1606-13. doi: 10.1093/ntr/ntw022. Epub 2016 Jan 27.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Katarzyna Jarus-Dziedzic, MD principal investigator
MTZ Clinical Research Inc (Warsaw, Poland)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distillation based smoking article (SMAR cigarette), conventional cigarette and smoking cessation in people with Smoking, run by Philip Morris Products S.A. at 1 site in Poland.
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 1 inclusion and 1 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 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
To demonstrate a reduction in the three primary biomarkers of exposure: Carboxyhaemoglobin concentration in blood, Urinary excretion of S-phenylmercapturic acid and urinary excretion of NNAL and NNAL-glucuronides (total NNAL) (time frame: 5 days). 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 NCT00812279, which also lists 1 linked publication.
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 7 Nov 2019.