Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 10/25/2017 |
| Start Date: | December 2013 |
| End Date: | May 2015 |
A Randomized, Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Apparently Healthy Smokers Switching to the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) or Observing Smoking Abstinence, Compared to Continuing to Use Menthol Conventional Cigarettes, for 5 Days in Confinement and Prolonged by 86 Days in an Ambulatory Setting
Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk
Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by
apparently adult healthy smokers results in a reduction in the levels of biomarkers of
exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).
Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by
apparently adult healthy smokers results in a reduction in the levels of biomarkers of
exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).
The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS)
for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult
healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to
selected harmful and potentially harmful constituents (HPHCs) compared to smokers continuing
smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking
abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide
context to the exposure reduction.
for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult
healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to
selected harmful and potentially harmful constituents (HPHCs) compared to smokers continuing
smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking
abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide
context to the exposure reduction.
Inclusion Criteria:
- Smoking, apparently healthy subject as judged by the Investigator.
- Subject smokes at least 10 commercially available mCCs per day (no brand restrictions)
for the last 4 weeks, based on self-reporting.
- Subject has smoked for at least the last 3 consecutive years.
- Subject does not plan to quit smoking within the next 6 months.
Exclusion Criteria:
- As per Investigator judgment, the subject cannot participate in the study for any
reason (e.g., medical, psychiatric, and/or social reason).
- The subject has received medication within 14 days or within 5 half-lives of the
medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
- For women: Subject is pregnant or is breast feeding.
- For women: Subject does not agree to use an acceptable method of effective
contraception.
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