At a glance
ClinicalIndex Comparison RecordN/ACompleted· 74 enrolled
Drug / intervention
P4M3 CA35 +3 moreother
Likely dose
Not stated in record
Key inclusion· 3
- ✓Smoker for ≥3 years (any cessation attempts did not exceed 6 months)
- ✓Smoked ≥10 cigarettes per day on average over the last 4 weeks before screening (verified by urinary cotinine ≥200 ng/mL)
- ✓Generally healthy as assessed by investigator based on screening evaluations (lab, spirometry, vitals, physical exam, ECG, medical history)
Key exclusion· 6
- ✕Clinically relevant disease requiring medication or other medical condition that would jeopardize safety
- ✕Acute illness or fever (body temperature >37.5°C) within 30 days prior to screening/admission
- ✕Medical conditions requiring intervention during study that may interfere with participation or results
- ✕Current asthma or COPD, or clinically significant spirometry findings at screening or baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Open-label, 4-arm Parallel Group Study to Demonstrate Reductions in Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) in Healthy Smokers Switching to 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System (ENDS), Compared to Continuing Smoking Cigarettes, or Abstaining From Smoking, for 5 Days in a Confinement Setting
In Brief
A clinical study evaluating P4M3 CA35, P4M3 CM35, and 2 other interventions for Nicotine and 2 related conditions. Completed, enrolled 74 participants across 1 site.
Detailed Summary
To demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected harmful and potentially harmful constituents (HPHC) in smokers switching from cigarette (CIG) to P4M3, an Electronic Nicotine Delivery System (ENDS), compared to continuing cigarette smoking for 5 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine, Vaping, Nicotine Vaping
CountriesUnited Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
Enrollment StartJul 2022
First PostedAug 2022
Primary CompletionAug 2022
Study CompletionNov 2022
TodayJul 2026
First PostedAug 4, 2022
Enrollment StartJul 15, 2022
Primary CompletionAug 31, 2022
Study CompletionNov 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.9 years ago
Interventions
P4M3 CA35other
Ad libitum use of P4M3 with CA35 cartridges
P4M3 CM35other
Ad libitum use of P4M3 with CM35 cartridges
CIGother
Ad libitum use of subject's own preferred brand of cigarettes
Smoking Abstinenceother
Abstention from cigarette smoking