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

NCT01989156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-03-24

Study results available
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Summary

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).

Conditions

  • Smoking

Interventions

OTHER

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

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

OTHER

Smoking Abstinence (SA)

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

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • William Lewis, MD · Covance Dallas

  • Frank Farmer, MD · Covance Daytona Beach

  • Christelle Haziza, PhD · Philip Morris Products S.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-10-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01989156 on ClinicalTrials.gov