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CSD201201: Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12

NCT05210699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-06-29

No results posted yet for this study

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.

Conditions

  • Smoking
  • Smoking Behaviors
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

Product A

Usual Brand (UB) filtered, menthol combustible cigarette

OTHER

Product B

Flavor variant P1211216 of a 1.5% nicotine ENDS product

OTHER

Product C

Flavor variant P1211217 of a 2.4% nicotine ENDS product

OTHER

Product D

Flavor variant P1211222 of a 5.0% nicotine ENDS product

OTHER

Product E

Flavor variant P1213616 of a 1.5% nicotine ENDS product

OTHER

Product N

Nicorette® White Ice Mint 4 mg nicotine gum

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Jason Hong, MD · RAIS

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2022-05-17
Completion
2022-05-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210699 on ClinicalTrials.gov