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Electronic Nicotine Delivery System

Product usage order A B N C E D 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 5 minutes to 240 minutes
Awards & highlights

Summary

This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]), and nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.

Eligible Conditions
  • Smoking
  • Tobacco Use
  • Tobacco Smoking

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes to 240 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes to 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
AUECPL 3-240
Emax PL

Trial Design

6Treatment groups
Experimental Treatment
Group I: Product usage order N A E B D CExperimental Treatment6 Interventions
Subjects will use each of the 5 products sequentially (N A E B D C) during an evaluation period, followed by a 4 hour Test Session.
Group II: Product usage order E N D A C BExperimental Treatment6 Interventions
Subjects will use each of the 5 products sequentially (E N D A C B) during an evaluation period, followed by a 4 hour Test Session.
Group III: Product usage order D E C N B AExperimental Treatment6 Interventions
Subjects will use each of the 5 products sequentially (D E C N B A) during an evaluation period, followed by a 4 hour Test Session.
Group IV: Product usage order C D B E A NExperimental Treatment6 Interventions
Subjects will use each of the 5 products sequentially (C D B E A N) during an evaluation period, followed by a 4 hour Test Session.
Group V: Product usage order B C A D N EExperimental Treatment6 Interventions
Subjects will use each of the 5 products sequentially (B C A D N E) during an evaluation period, followed by a 4 hour Test Session.
Group VI: Product usage order A B N C E DExperimental Treatment6 Interventions
Subjects will use each of the 5 products sequentially (A B N C E D) 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
7,581 Total Patients Enrolled
33 Trials studying Smoking
5,068 Patients Enrolled for Smoking
Jason Hong, MDStudy DirectorRAIS
6 Previous Clinical Trials
311 Total Patients Enrolled
3 Trials studying Smoking
119 Patients Enrolled for Smoking
~11 spots leftby Sep 2025
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