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

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: THS 2.2 Menthol (mTHS 2.2); Other: Smoking Abstinence (SA); Other: Menthol Conventional Cigarette (mCC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01989156

ZRHM-REXA-08-US (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

THS 2.2 Menthol (mTHS 2.2)

Experimental group

Description:

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

Treatment:

Other: THS 2.2 Menthol (mTHS 2.2)

Menthol Conventional Cigarette (mCC)

Active Comparator group

Description:

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

Treatment:

Other: Menthol Conventional Cigarette (mCC)

Smoking abstinence (SA)

Sham Comparator group

Description:

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

Treatment:

Other: Smoking Abstinence (SA)