Brief Summary

To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess quality of life measures in smokers randomly switched from their usual brand of cigarette to one of three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco); or (3) an ultra-low machine yield tobacco-burning cigarette.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

163

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

February 1, 2007

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed

4.3 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed

8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed

Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

February 5, 2014

Last Update Submit

February 15, 2016

Conditions

Cigarette Smoking

Keywords

BiomarkersTobaccoTobacco-heatingSmokeless TobaccoSnusSmokingExposureQuality of Life

Outcome Measures

Primary Outcomes (14)

Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12
Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity
Week 12
Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12
Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin
Week 12
Change in Markers of Exposure and Potential Harm from Weeks 0 to 12
Exhaled carbon monoxide and spirometry
Week 12
Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 12
St. George's Respiratory Questionnaire and Leicester Cough Questionnaire
Week 12
Change in tobacco usage diary from Weeks 0 to 4
Week 4
Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 24
Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity
Week 24
Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24
Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin
Week 24
Change in Markers of Exposure and Potential Harm from Weeks 0 to 24
Exhaled carbon monoxide and spirometry
Week 24
Change in daily tobacco usage diary from Weeks 4 to 8
Week 8
Change in daily tobacco usage diary from Weeks 8 to 12
Week 12
Change in daily tobacco usage diary from Weeks 12 to 16
Week 16
Change in daily tobacco usage diary from Weeks 16 to 20
Week 20
Change in daily tobacco usage diary from Weeks 20 to 24
Week 24
Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 24
St. George's Respiratory Questionnaire and Leicester Cough Questionnaire
Week 24

Secondary Outcomes (4)

Change in Nicotine Yield versus Uptake from Weeks 0 to 12
Week 12
Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 12
Week 12
Change in Nicotine Yield versus Uptake from Weeks 0 to 24
Week 24
Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 24
Week 24

Study Arms (3)

Tobacco-Heating Cigarette

EXPERIMENTAL

A group of 44 subjects who smoke and are switched to a tobacco-heating cigarette

Other: Tobacco-Heating Cigarette

Snus (Smokeless Tobacco)

EXPERIMENTAL

A group of 43 subjects who smoke and are switched to snus (smokeless tobacco)

Other: Snus (Smokeless Tobacco)

Tobacco-Burning Cigarette

EXPERIMENTAL

A group of 44 subjects who smoke and are switched to a tobacco-burning ultra-low machine yield cigarette

Other: Tobacco-Burning Cigarette

Interventions

Tobacco-Heating CigaretteOTHER

Smokers switched to a tobacco-heating cigarette for 24 weeks

Tobacco-Heating Cigarette

Snus (Smokeless Tobacco)OTHER

Smokers switched to snus product for 24 weeks

Snus (Smokeless Tobacco)

Tobacco-Burning CigaretteOTHER

Smokers switched to a tobacco-burning cigarette for 24 weeks

Tobacco-Burning Cigarette

Eligibility Criteria

Age28 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Males or females, between 28 and 55 years of age, inclusive.
Cigarette-only smokers who currently smoked at least 15 cigarettes daily and who smoked for at least 10 years prior to Week 0 (i.e., chronic cigarette smokers).
Smokers not intending to quit smoking, but willing to switch their tobacco product (intent to quit was defined as intending to make or making a quit attempt within 1 month prior to Week 0).
Non-smoking subjects who self-reported "Never-Smoker" per the American Thoracic Society Questionnaire definition, and did not have urinary cotinine levels exceeding 50 ng/mL.
Subjects, in the opinion of the Investigators, free of clinically significant health problems and not on medication on a daily basis for chronic medical disorders deemed clinically significant by the Investigator(s).
Subjects not regularly taking creatine supplements.
Subjects testing negative for selected drugs of abuse at Screening (included alcohol test).
Female subjects who were non-pregnant (urine pregnancy test results were negative at Screening and Weeks 0, 12, and 24), non-lactating, and either postmenopausal (as verified by Follicle Stimulating Hormone levels) for at least 1 year, surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days, or agreed to use from the time of signing the informed consent until 30 days after Week 24 (or Study Completion) a form of contraception considered acceptable to the Investigators (such as oral, injectable or implantable contraceptives, intrauterine devices and barrier methods ).
Subjects able to read and comprehend questionnaires in English and willing to sign an Informed Consent Form.

You may not qualify if:

Smokers using any other tobacco or nicotine-containing product or device other than tobacco-burning cigarettes from 6 months prior to the study through Week 24, including cigars, pipes, chewing tobacco, snuff, snus, nicotine patch, nicotine gum, etc.
A history or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders.
A history of hypersensitivity or allergies to any drug compound unless approved by the Investigator(s).
A history or presence of an abnormal ECG deemed clinically significant by the Investigator.
A history of alcoholism or drug addiction within 1 year prior to Study Entry.
Evidence of visible oral cancer, as found in an oral health examination or based on oral health questions at each visit.
Any acute or chronic condition that, in the Investigator(s)' opinion, limited the subject's ability to complete and/or participate in the study.
Donation of blood from 30 days prior to Screening through Week 24 (or Study Completion), inclusive, or plasma from 2 weeks prior to Screening through Week 24 (or Study Completion), inclusive.
Receipt of blood products within 2 months prior to Study Entry.
Subject or a relative of the subject was currently or had ever been employed by the tobacco industry.
Subject participated in any other investigational study drug or product trial in which receipt of an investigational study drug or product occurred within 30 days prior to Check-in (inclusive).

Contact the study team to confirm eligibility.