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

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: smoking cessation; Other: Distillation based smoking article (SMAR cigarette); Other: conventional cigarette

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812279

YVD-CS01-EU

Details and patient eligibility

About

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.

Full 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).

Enrollment: 112 patients

Sex: All

Ages: 23 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

1. SMAR

Experimental group

Description:

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

Treatment:

Other: Distillation based smoking article (SMAR cigarette)

2 Conventional cigarette (CC)

Active Comparator group

Description:

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

Treatment:

Other: conventional cigarette

3. smoking cessation (SC)

Active Comparator group

Description:

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

Treatment:

Other: smoking cessation