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

NCT01989156 | Completed Results

• 1 other identifier: ZRHM-REXA-08-US
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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).

Conditions

Smoking

Keywords

Smoking; Candidate modified risk tobacco product; Menthol conventional cigarettes; Reduced exposure; HPHCs; Ambulatory

Outcome Measures

Primary Outcomes (5)

• Concentration of Monohydroxybutenylmercapturic Acid (MHBMA)

  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.

  5 days

• Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

  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.

  5 days

• Concentration of S-phenylmercapturic Acid (S-PMA)

  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.

  5 days

• Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL)

  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.

  90 days

• Levels of Carboxyhemoglobin (COHb)

  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.

  5 days

Study Arms (3)

THS 2.2 Menthol (mTHS 2.2)

EXPERIMENTAL

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)

Menthol Conventional Cigarette (mCC)

ACTIVE COMPARATOR

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)

Smoking abstinence (SA)

SHAM COMPARATOR

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

Other: Smoking Abstinence (SA)

Interventions

THS 2.2 Menthol (mTHS 2.2) OTHER

THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

THS 2.2 Menthol (mTHS 2.2)

Menthol Conventional Cigarette (mCC) OTHER

Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

Menthol Conventional Cigarette (mCC)

Smoking Abstinence (SA) OTHER

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

Smoking abstinence (SA)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (2)

Covance Daytona Beach, 1900 Mason Ave., Suite 140

Daytona Beach, Florida, 32117, United States

Location

Covance Dallas, 1341 W. Mockingbird Ln., Ste 400E

Dallas, Texas, 75247, United States

Location

Related Publications (2)

• Haziza C, de La Bourdonnaye G, Donelli A, Skiada D, Poux V, Weitkunat R, Baker G, Picavet P, Ludicke F. Favorable Changes in Biomarkers of Potential Harm to Reduce the Adverse Health Effects of Smoking in Smokers Switching to the Menthol Tobacco Heating System 2.2 for 3 Months (Part 2). Nicotine Tob Res. 2020 Apr 17;22(4):549-559. doi: 10.1093/ntr/ntz084.

  PMID: 31125079 DERIVED

• Haziza C, de La Bourdonnaye G, Donelli A, Poux V, Skiada D, Weitkunat R, Baker G, Picavet P, Ludicke F. Reduction in Exposure to Selected Harmful and Potentially Harmful Constituents Approaching Those Observed Upon Smoking Abstinence in Smokers Switching to the Menthol Tobacco Heating System 2.2 for 3 Months (Part 1). Nicotine Tob Res. 2020 Apr 17;22(4):539-548. doi: 10.1093/ntr/ntz013.

  PMID: 30722062 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Analysis of Primary Outcomes required data from the PP set at Baseline, Day 5 (MHBMA, 3-HPMA, S-PMA, and COHb), and Day 90 (Total NNAL). Differences in the number of participants for each outcome is due to missing data at baseline or at Day5/90.

Results Point of Contact

• Title: Christelle Haziza, PhD
• Organization: Philip Morris Products S.A.

Christelle.Haziza@pmi.com

+41 (58) 242 2625

Study Officials

• William Lewis, MD

  Covance Dallas

  PRINCIPAL INVESTIGATOR

• Frank Farmer, MD

  Covance Daytona Beach

  PRINCIPAL INVESTIGATOR

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: March 24, 2020
• Results First Posted: April 5, 2017

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)