Smoking Research Study

NCT01465880 | Completed

• 1 other identifier: PIPA_CEMA_01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking; Non-smoking

Keywords

Smoking research study

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  24 hours

Study Arms (2)

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.

Other: Part A

Interventions

Part A OTHER

Smoking abstinence, smoking 2 and 4 cigarettes

Part A.Healthy Caucasian adult smokers

Eligibility Criteria

• Age: 23 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, South Wales, CF48 4DR, United Kingdom

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Salvatore Febbraro, MD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: November 7, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

GB (1)