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Completed

NCT Number: NCT01970995

Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke 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.

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Key information

Conditions

Smoking Behavior

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is Japanese.
  • Smoking, 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 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).
  • The 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 1 A2 (CYP1A2) or cytochrome P450 2 A6 (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.

Treatment and study plan

THS 2.2 Menthol (mTHS 2.2)

Other

THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

Smoking Abstinence (SA)

Other

SA for 5 days in confinement prolonged by 85 days in an ambulatory setting

Menthol Conventional Cigarette (mCC)

Other

Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

Primary outcomes

  1. Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)

    Time frame: 5 days

    Concentrations measured at Day 5 in urine, adjusted for creatinine.

    Geometric Least Squares (LS) means are provided as descriptive statistics.

  2. Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

    Time frame: 5 days

    Concentrations measured at Day 5 in urine, adjusted for creatinine.

    Geometric Least Squares (LS) means are provided as descriptive statistics.

  3. Concentration of S-phenylmercapturic Acid (S-PMA)

    Time frame: 5 days

    Concentrations measured at Day 5 in urine, adjusted for creatinine.

    Geometric Least Squares (LS) means are provided as descriptive statistics.

  4. Levels of Carboxyhemoglobin (COHb)

    Time frame: 5 days

    % COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.

    Geometric Least Squares means are provided as descriptive statistics.

  5. Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)

    Time frame: 90 days

    Concentrations measured at Day 90 in urine, adjusted for creatinine.

    Geometric Least Squares (LS) means are provided as descriptive statistics.

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study title

A Randomized, Controlled, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smokers Switching to THS 2.2 Menthol or Smoking Abstinence Compared to Smoking Menthol Conventional Cigarettes, for 90 Days

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2013
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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