SmokingNCT01465880
Smoking Research Study
A study testing Part A in people with Smoking and Non-smoking, run by Philip Morris Products S.A. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to develop a fit-for-purpose biochemical verification tool that can be used to detect concomitant use of a few (less than 5) conventional cigarettes. Read more about this study
- Who is it for?
- Ages 23 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Non-smoking
- What is being tested?
- Part A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Nov 2011
- 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
- Common criteria to smokers and non-smokers
- Subject is able to understand the information provided in the Subject Information sheet and Informed Consent Form (ICF)
- Subject has signed the ICF
- Subject of Caucasian origin
- Aged from 23 to 55 years
- Having acceptable health conditions as judged by the Investigator at the screening visit based on clinical laboratory parameters (clinical biochemistry, urine analysis and standard haematology), spirometry, serology, urine drug screen, vital signs, physical examination, ECG, and medical history
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- Specific to smokers
- Current smoker based on self-reporting who smoke 5 to 15 commercially available non-mentholated conventional cigarettes (no brand restrictions) with a maximum tar yield of 10 mg (ISO method, as labelled on the cigarette package) smoking at least for the last 3 consecutive years. The smoking status will be verified at screening based on a urinary cotinine test (cotinine ≥200ng/ml)
- Subject is willing to smoke according to the smoking regimen of the study
- Specific to non-smokers
- Non-smoker based on self-reporting who have not used any tobacco or nicotine containing product including commercially available cigarettes, hand-rolled cigarettes, cigars, pipes, snuff, electronic cigarettes, similar devices, and nicotine replacement therapy within the last 12 months. The non-smoking status of the subject will be verified at screening based on a urinary cotinine test (cotinine <200ng/ml)
Who cannot join
- Common criteria to smokers and non-smokers
- As per judgement of the Investigator, any subject who cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason)
- Any clinically relevant gastrointestinal, renal, hepatic, neurological, haematological, endocrine, oncological, urological, immunological and cardiovascular diseases or any other condition including clinically significant abnormal laboratory parameters that, in the opinion of the Investigator, could jeopardise the safety of the subject or impact the validity of the study results
- Lung cancer, upper respiratory tract cancers, chronic respiratory diseases or any other clinically significant pulmonary diseases according to the judgement of the Investigator
- Any medical conditions requiring smoking cessation (e.g., recent acute cardiovascular event, diabetes mellitus, Chronic Obstructive Pulmonary disease)
- Subject with body mass index < 18.5 or ≥ 30 kg/m2
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- As per judgement of the Investigator, medical conditions which require or will require in the course of the study a medical intervention (e.g., start of treatment, surgery, hospitalisation) which may interfere with the study participation and/or study results
- Donation or receipt of whole blood or blood products within 3 months prior to the screening visit
- Participation in any clinical studies within 3 months before the screening visit
- Current or former employee of the tobacco industry, or of their first-degree relatives (parent, sibling, child)
- Employee of the investigational site or any other parties involved in the study or of their first-degree relatives (parent, sibling, child)
- Enrolled in the same study at a different time (i.e., each subject can be in the study population only once)
- Subject who is legally incompetent, physically or mentality incapable of giving consent (e.g., emergency situation, under guardianship, subject in a social or sanitary establishment, prisoners or subject who are involuntarily incarcerated)
- Positive alcohol test and/or history of alcohol abuse that could interfere with subject's participation in study
- Positive urine drug tests (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates)
- Positive serology test (HbsAg, HCV, HIV)
- Specific to smokers
- Subject who has used any nicotine-containing products other than commercially available cigarettes (either a tobacco-based product or nicotine-replacement therapy) as well as electronic cigarettes and similar devices within 1 month prior to the screening visit
- Additionally, women of childbearing potential must be excluded if:
- Subject is pregnant (does not have negative pregnancy tests at screening and at admission) 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) from screening until the end of the safety follow-up period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Ltd
Merthyr Tydfil, South Wales, CF48 4DR
About this study
Official title: A Single-centre, Dose Titration Study in Healthy Volunteers (Smokers and Non-smokers) to Evaluate the Capacity of 2-cyanoethylmercapturic Acid (CEMA) to Detect Low Level of Cigarette Smoking Exposure
The purpose of this study is to develop a fit-for-purpose biochemical verification tool that can be used to detect concomitant use of a few (less than 5) conventional cigarettes.
Read the detailed description
This study will be performed in two parts. The first part, Part A, is a dose titration study in healthy smokers with incremental cigarette consumption performed in confinement. The second part, Part B, is an observational study on healthy non-smokers in an ambulatory setting
PART A (smokers only)
A screening visit will be conducted within 4 weeks prior to admission to the investigational site. The 8-day confinement period consists of the admission day (Day1), 1 day ad-libitum smoking (Day0), 3 days of smoking abstinence (Day1-3), 2-day exposure period smoking 2 and 4 cigarettes (Day4-5), and the day of discharge (Day6) followed by a 7-day safety follow-up period. Urine collection will be performed for each subject from Day0 to Day5 in 4 intervals.
PART B (non-smokers)
Screening visit will be conducted within 4 weeks prior to the ambulatory Visit 1 (collection of 24-hour urine and spot urine) to the investigational site. The minimum interval between the screening and Visit 1 is of 7 days.
- Conditions
- Smoking, Non-smoking
- Being tested
- Part A
- Keywords
- Smoking research study
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part AOther
Smoking abstinence, smoking 2 and 4 cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Part B. Healthy Caucasian adult non-smokers | No intervention | Non-smokers |
| Part A.Healthy Caucasian adult smokers | Experimental | No product will be investigated in this study. Smokers will smoke their own conventional cigarettes only. Receives: Other: Part A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour urine of smokers smoking 2 or 4 conventional cigarettes
To demonstrate that CEMA, used as a urinary biomarker, can identify subjects who have smoked 4 or less conventional cigarettes
Measured: After smoking 2 or 4 conventional cigarettes, within 24 hours
Secondary outcomes (2)
Levels of CEMA in 24-hour urine, carboxyhaemoglobin (COHb) in blood and carbon monoxide in exhaled breath of smokers smoking 2 or 4 conventional cigarettes
To evaluate the ability of CEMA to detect conventional cigarette use in comparison to COHb and exhaled carbon monoxide
Measured: After smoking 2 or 4 conventional cigarettes, within 24 hours
Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour and spot urine of non-smokers
To evaluate the correlation between the levels of CEMA in 24-hour urine and in spot urine in non-smokers
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Febbraro, MD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465880
- Sponsor's protocol ID
- PIPA_CEMA_01
- Status last verified
- Dec 2011
- First submitted
- 14 Oct 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Dose Titration Study in Healthy Volunteers (Smokers and Non-smokers) to Evaluate the Capacity of 2-cyanoethylmercapturic Acid (CEMA) to Detect Low Level of Cigarette Smoking Exposure
- ClinicalTrials.gov ID
- NCT01465880
- Acronym / sponsor ID
- PIPA_CEMA_01
- Conditions
- Smoking, Non-smoking
- Keywords
- Smoking research study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Nov 2011 (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 purpose of this study is to develop a fit-for-purpose biochemical verification tool that can be used to detect concomitant use of a few (less than 5) conventional cigarettes.
Detailed description
This study will be performed in two parts. The first part, Part A, is a dose titration study in healthy smokers with incremental cigarette consumption performed in confinement. The second part, Part B, is an observational study on healthy non-smokers in an ambulatory setting
PART A (smokers only)
A screening visit will be conducted within 4 weeks prior to admission to the investigational site. The 8-day confinement period consists of the admission day (Day1), 1 day ad-libitum smoking (Day0), 3 days of smoking abstinence (Day1-3), 2-day exposure period smoking 2 and 4 cigarettes (Day4-5), and the day of discharge (Day6) followed by a 7-day safety follow-up period. Urine collection will be performed for each subject from Day0 to Day5 in 4 intervals.
PART B (non-smokers)
Screening visit will be conducted within 4 weeks prior to the ambulatory Visit 1 (collection of 24-hour urine and spot urine) to the investigational site. The minimum interval between the screening and Visit 1 is of 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part B. Healthy Caucasian adult non-smokers | No intervention | –Non-smokers |
| Part A.Healthy Caucasian adult smokers | Experimental | Other: Part ANo product will be investigated in this study. Smokers will smoke their own conventional cigarettes only. |
Who may qualify
- Ages
- 23 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Common criteria to smokers and non-smokers
- Subject is able to understand the information provided in the Subject Information sheet and Informed Consent Form (ICF)
- Subject has signed the ICF
- Subject of Caucasian origin
- Aged from 23 to 55 years
Key exclusion criteria (21 listed)
- Common criteria to smokers and non-smokers
- As per judgement of the Investigator, any subject who cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason)
- Any clinically relevant gastrointestinal, renal, hepatic, neurological, haematological, endocrine, oncological, urological, immunological and cardiovascular diseases or any other condition including clinically significant abnormal laboratory parameters that, in the opinion of the Investigator, could jeopardise the safety of the subject or impact the validity of the study results
- Lung cancer, upper respiratory tract cancers, chronic respiratory diseases or any other clinically significant pulmonary diseases according to the judgement of the Investigator
- Any medical conditions requiring smoking cessation (e.g., recent acute cardiovascular event, diabetes mellitus, Chronic Obstructive Pulmonary disease)
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 |
|---|---|---|
| Part ASmoking abstinence, smoking 2 and 4 cigarettes | Other | Part A.Healthy Caucasian adult smokers |
Primary outcome
Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour urine of smokers smoking 2 or 4 conventional cigarettes
Time frame: After smoking 2 or 4 conventional cigarettes, within 24 hours
To demonstrate that CEMA, used as a urinary biomarker, can identify subjects who have smoked 4 or less conventional cigarettes
2 secondary outcomes
Levels of CEMA in 24-hour urine, carboxyhaemoglobin (COHb) in blood and carbon monoxide in exhaled breath of smokers smoking 2 or 4 conventional cigarettes
Time frame: After smoking 2 or 4 conventional cigarettes, within 24 hours
Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour and spot urine of non-smokers
Time frame: 24 hours
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 21 Dec 2011.
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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.
Salvatore Febbraro, MD principal investigator
Simbec Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Part A in people with Smoking and Non-smoking, run by Philip Morris Products S.A. at 1 site in United Kingdom.
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 11 inclusion and 21 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 21 Dec 2011. 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 United Kingdom. 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?
Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour urine of smokers smoking 2 or 4 conventional cigarettes (time frame: After smoking 2 or 4 conventional cigarettes, within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2011.