NCT01780714

Brief Summary

The goal of this exploratory study is to evaluate the effect of a candidate modified risk tobacco product (MRTP), THS 2.1, on selected biomarkers of exposure to harmful and potentially harmful smoke constituents (HPHCs), compared to conventional cigarettes (CC). The subjective effects (urge to smoke and withdrawal symptoms) which are related to the use of this product will be explored. Initial information on safety and on some biological effects when using THS 2.1 will be collected. Human Smoking Topography (HST) will be explored.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

January 15, 2013

Last Update Submit

November 18, 2019

Conditions

Smoking

Keywords

smokingcigaretteexposurebiomarkerhuman smoking topography (HST)modified risk tobacco product (MRTP)THS 2.1

Outcome Measures

Primary Outcomes (1)

  • Evaluation of carboxyhemoglobin (COHb) levels in blood, and evaluation of excretion of 3-hydroxypropyl mercapturic acid (3-HPMA), monohydroxybutenyl mercapturic acid (MHBMA), and S-phenyl mercapturic acid (S-PMA) in 24-hour urine on switching to THS 2.1

    Biomarkers of exposure to carbon monoxide (CO), acrolein, 1,3-butadiene, and benzene

    5 days

Secondary Outcomes (10)

  • Selected secondary biomarkers of exposure to HPHCs

    5 days

  • CYP1A2 activity and CYP2A6 activity

    5 days

  • Plasma nicotine

    5 days

  • 11-dehydro-thromboxane B2 (11-DTX-B2)

    5 days

  • Product use and smoking topography

    Up to 5 days

  • +5 more secondary outcomes

Study Arms (2)

Conventional cigarettes (CC)

ACTIVE COMPARATOR

Smokers are continuing to smoke exclusively their usual own brand of CC, for 5 days, ad libitum, under highly controlled conditions

Other: Conventional cigarettes (CC)

Tobacco Heating System 2.1 (THS 2.1)

EXPERIMENTAL

Smokers are switching to the exclusive and ad-libitum use of THS 2.1 for 5 days, under highly controlled conditions

Other: THS 2.1

Interventions

Conventional cigarettes (CC)OTHER

Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1

Conventional cigarettes (CC)
THS 2.1OTHER

Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1

Tobacco Heating System 2.1 (THS 2.1)

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has signed an informed consent form before commencement of study procedures
  • Healthy Caucasian aged between 23 to 65 years
  • Subject is a current smoker for at least 3 years (based on self-reporting and biochemically verified), who, for the last 4 weeks, had smoked at least 10 commercially available non-mentholated CC per day, and is not planning to make a quit attempt within the next 3 months

You may not qualify if:

  • As per Investigator judgment, the subject should not participate in the study for any reason (e.g. medical, psychiatric and/or social reason)
  • The subject has a medical condition requiring smoking cessation, or has a clinically relevant disease / condition which could interfere with the study participation and/or study results
  • The subject has participated in a clinical study within 3 months prior to the Screening Visit
  • Pregnant or lactating woman, and for woman of childbearing potential, absence / refusal to use an acceptable method of effective contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MTZ Clinical Research Sp. z o.o.

Warsaw, 02-106, Poland

Location

Related Publications (1)

  • Ludicke F, Baker G, Magnette J, Picavet P, Weitkunat R. Reduced Exposure to Harmful and Potentially Harmful Smoke Constituents With the Tobacco Heating System 2.1. Nicotine Tob Res. 2017 Feb;19(2):168-175. doi: 10.1093/ntr/ntw164. Epub 2016 Jul 1.

    PMID: 27613951RESULT

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Katarzyna Jarus-Dziedzic, MD PhD

    MTZ Clinical Research Sp. z o.o., Warsaw, Poland

    PRINCIPAL INVESTIGATOR

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

January 15, 2013

First Posted

January 31, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations

PL(1)