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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

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ClinicalTrials.gov Identifier: NCT01989156
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : April 5, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief 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).

Condition or disease Intervention/treatment Phase
Smoking Other: THS 2.2 Menthol (mTHS 2.2) Other: Menthol Conventional Cigarette (mCC) Other: Smoking Abstinence (SA) Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : December 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 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
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

Active Comparator: 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
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

Sham Comparator: Smoking abstinence (SA)
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
Other: Smoking Abstinence (SA)
SA for 5 days in confinement prolonged by 86 days in an ambulatory setting




Primary Outcome Measures :
  1. Concentration of Monohydroxybutenylmercapturic Acid (MHBMA) [ Time Frame: 5 days ]
    Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

  2. Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) [ Time Frame: 5 days ]
    Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

  3. Concentration of S-phenylmercapturic Acid (S-PMA) [ Time Frame: 5 days ]
    Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

  4. Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL) [ Time Frame: 90 days ]
    Concentrations measured in urine, adjusted for creatinine, at Day 90 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

  5. Levels of Carboxyhemoglobin (COHb) [ Time Frame: 5 days ]
    Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5, for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989156


Locations
United States, Florida
Covance Daytona Beach, 1900 Mason Ave., Suite 140
Daytona Beach, Florida, United States, 32117
United States, Texas
Covance Dallas, 1341 W. Mockingbird Ln., Ste 400E
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
Principal Investigator: William Lewis, MD Covance Dallas
Principal Investigator: Frank Farmer, MD Covance Daytona Beach
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.

Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01989156     History of Changes
Other Study ID Numbers: ZRHM-REXA-08-US
ZRHM-REXA-08-US ( Other Identifier: Philip Morris Products S.A. )
First Posted: November 20, 2013    Key Record Dates
Results First Posted: April 5, 2017
Last Update Posted: October 23, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philip Morris Products S.A.:
Smoking
Candidate modified risk tobacco product
Menthol conventional cigarettes
Reduced exposure
HPHCs
Ambulatory

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents