Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article

NCT00812279 | Completed

• 1 other identifier: YVD-CS01-EU
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking

Keywords

Smokers with acceptable health conditions

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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.

  5 days

• To assess urinary excretion of nicotine and its five major nicotine metabolites in the three study arms

  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

  5 days

• To assess the mutagenicity potential in urine at the end of the study in the three study arms

  5 days

Study Arms (3)

1. SMAR

EXPERIMENTAL

Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times.

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.

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.

Other: smoking cessation

Interventions

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.

1. SMAR

conventional cigarette OTHER

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.

2 Conventional cigarette (CC)

smoking cessation OTHER

Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation.

3. smoking cessation (SC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

MTZ Clinical Research Inc.

Warsaw, 02-106, Poland

Location

Related Publications (1)

• 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.

  PMID: 26817490 RESULT

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Katarzyna Jarus-Dziedzic, MD

  MTZ Clinical Research Inc (Warsaw, Poland)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 7, 2019

Record last verified: 2019-11

Locations

PL (1)