Study Summary
This trial will help determine if policies restricting access to menthol-flavored HTPs will have an impact on menthol cigarette smokers.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: Week 2, Friday Clinical Lab visit (10 puff bout period)
Week 2
Change in Average Daily Cigarette Use
Week 2
Average daily IQOS Usage
Percentage of total tobacco consumption that is IQOS
Week 2
Cigarette Craving Suppression
Week 2
Willingness to Substitute from Cigarettes to HTPs
Week 2
Menthol
Plasma Nicotine Delivery
Puff Topography (Puff Duration)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Tobacco-Flavored IQOS
1 of 2
Menthol-Flavored IQOS
1 of 2
Active Control
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Tobacco product administration and assessment · No Placebo Group · N/A
Menthol-Flavored IQOS
Device
Experimental Group · 1 Intervention: Tobacco product administration and assessment · Intervention Types: DeviceTobacco-Flavored IQOS
Device
ActiveComparator Group · 1 Intervention: Tobacco product administration and assessment · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tobacco product administration and assessment
2016
N/A
~30
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 2, friday clinical lab visit (10 puff bout period)
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
624 Previous Clinical Trials
355,744 Total Patients Enrolled
1 Trials studying Tobacco Use
32 Patients Enrolled for Tobacco Use
National Institute on Drug Abuse (NIDA)NIH
2,248 Previous Clinical Trials
2,029,037 Total Patients Enrolled
21 Trials studying Tobacco Use
5,532 Patients Enrolled for Tobacco Use
Andrew J Barnes, PhDPrincipal InvestigatorVirginia Commonwealth University
2 Previous Clinical Trials
235 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a daily menthol cigarette smoker.
You must be willing to receive and respond to daily surveys.
Unbiased ResultsWe believe in providing patients with all the options.
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Conditions
Cancer Related
Treatments