N/A
Completed N=160
Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
Source: ClinicalTrials.gov NCT01959932 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) — 194.05; 2314.37; 168.01 pg/mg creat — p=<0.001
Summary
The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) |
194.05; 2314.37; 168.01 | <0.001 sig |
| PRIMARY Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) |
398.87; 958.03; 242.56 | <0.001 sig |
| PRIMARY Concentration of S-phenylmercapturic Acid (S-PMA) |
164.51; 2748.16; 153.66 | <0.001 sig |
| PRIMARY Levels of Carboxyhemoglobin (COHb) |
1.06; 4.53; 0.98 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is Caucasian.
- Current healthy smoker as judged by the Principal Investigator.
- Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
- 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).
- 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 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
- Female subject is pregnant or breast feeding.
- Female subject does not agree to use an acceptable method of effective contraception.
Data sourced from ClinicalTrials.gov (NCT01959932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.