Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

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Detailed Description

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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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Tobacco Heating System (THS 2.2)

Ad libitum use of THS 2.2 for 5 days in confinement

Group Type EXPERIMENTAL

Tobacco Heating System (THS 2.2)

Intervention Type OTHER

THS 2.2 ad libitum for 5 days in confinement

Smoking abstinence (SA)

Abstinence from smoking for 5 days in confinement

Group Type SHAM_COMPARATOR

Smoking abstinence (SA)

Intervention Type OTHER

SA for 5 days in confinement

Conventional cigarette (CC)

Ad libitum use of subject's own preferred brand of CC for 5 days in confinement

Group Type ACTIVE_COMPARATOR

Conventional cigarette (CC)

Intervention Type OTHER

Subject's own preferred brand of CC ad libitum for 5 days in confinement

Interventions

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Tobacco Heating System (THS 2.2)

THS 2.2 ad libitum for 5 days in confinement

Intervention Type OTHER

Smoking abstinence (SA)

SA for 5 days in confinement

Intervention Type OTHER

Conventional cigarette (CC)

Subject's own preferred brand of CC ad libitum for 5 days in confinement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is Caucasian.
* Current healthy smoker as judged by the Principal Investigator.
* Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 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).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes