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Electronic Nicotine Delivery System

Product usage order ABECD for Smoking

N/A
Waitlist Available
Research Sponsored by RAI Services Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 minutes
Awards & highlights

Summary

This is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.

Eligible Conditions
  • Smoking
  • Tobacco Smoking
  • Tobacco Use

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUCnic0-240
Cmax

Trial Design

10Treatment groups
Experimental Treatment
Group I: Product usage order EDACBExperimental Treatment5 Interventions
Subjects will use each of the 5 products (EDACB) during an evaluation period, followed by a 4 hour Test Session
Group II: Product usage order EADBCExperimental Treatment5 Interventions
Subjects will use each of the 5 products (EADBC) during an evaluation period, followed by a 4 hour Test Session
Group III: Product usage order DECABExperimental Treatment5 Interventions
Subjects will use each of the 5 products (DECAB) during an evaluation period, followed by a 4 hour Test Session
Group IV: Product usage order DCEBAExperimental Treatment5 Interventions
Subjects will use each of the 5 products (DCEBA) during an evaluation period, followed by a 4 hour Test Session
Group V: Product usage order CDBEAExperimental Treatment5 Interventions
Subjects will use each of the 5 products (CDBEA) during an evaluation period, followed by a 4 hour Test Session
Group VI: Product usage order CBDAEExperimental Treatment5 Interventions
Subjects will use each of the 5 products (CBDAE) during an evaluation period, followed by a 4 hour Test Session
Group VII: Product usage order BCADEExperimental Treatment5 Interventions
Subjects will use each of the 5 products (BCADE) during an evaluation period, followed by a 4 hour Test Session
Group VIII: Product usage order BACEDExperimental Treatment5 Interventions
Subjects will use each of the 5 products (BACED) during an evaluation period, followed by a 4 hour Test Session
Group IX: Product usage order AEBDCExperimental Treatment5 Interventions
Subjects will use each of the 5 products (AEBDC) during an evaluation period, followed by a 4 hour Test Session
Group X: Product usage order ABECDExperimental Treatment5 Interventions
Subjects will use each of the 5 products (ABECD) during an evaluation period, followed by a 4 hour Test Session

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Who is running the clinical trial?

RAI Services CompanyLead Sponsor
41 Previous Clinical Trials
7,584 Total Patients Enrolled
33 Trials studying Smoking
5,071 Patients Enrolled for Smoking
Jason Hong, MDStudy DirectorRAIS
6 Previous Clinical Trials
314 Total Patients Enrolled
3 Trials studying Smoking
122 Patients Enrolled for Smoking
~7 spots leftby Sep 2025
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