Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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THS 2.2 Menthol (mTHS 2.2)

Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting

Group Type EXPERIMENTAL

THS 2.2 Menthol (mTHS 2.2)

Intervention Type OTHER

THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

Menthol Conventional Cigarette (mCC)

Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting

Group Type ACTIVE_COMPARATOR

Menthol Conventional Cigarette (mCC)

Intervention Type OTHER

Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

Smoking abstinence (SA)

Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting

Group Type SHAM_COMPARATOR

Smoking Abstinence (SA)

Intervention Type OTHER

SA for 5 days in confinement prolonged by 86 days in an ambulatory setting

Interventions

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THS 2.2 Menthol (mTHS 2.2)

THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

Intervention Type OTHER

Menthol Conventional Cigarette (mCC)

Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

Intervention Type OTHER

Smoking Abstinence (SA)

SA for 5 days in confinement prolonged by 86 days in an ambulatory setting

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes