At a glance
ClinicalIndex Comparison RecordN/ACompleted· 64 enrolled
Drug / intervention
mTHS 2.2 +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Nasal Spray
In Brief
A clinical study evaluating mTHS 2.2, mCC, and 1 other intervention for Smoking. Completed, enrolled 64 participants across 1 site.
Detailed Summary
The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionNov 2013
Study CompletionMay 2014
TodayJul 2026
First PostedOct 23, 2013
Enrollment StartOct 1, 2013
Primary CompletionNov 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.7 years ago
Interventions
mTHS 2.2other
Single use of mTHS 2.2
mCCother
Single use of subject's own mCC
NNSother
Single administration of 1 mg of nicotine