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CSD170401: Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement

NCT03126357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-06-27

No results posted yet for this study

Summary

This study will examine elements of abuse liability (AL) related to potential product adoption of three electronic tobacco vapor products by current smokers relative to high and low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in subjective measures, speed and amount of nicotine uptake, and maximum changes in physiological effects during and after product use that follows a 12-hour (minimum) tobacco and nicotine abstinence period, will be determined. The electronic tobacco vapor products will not be compared to each other.

Conditions

  • Smoking

Interventions

OTHER

Product A

Usual Brand Cigarette

OTHER

Product B

FT21039 an electronic tobacco vapor product

OTHER

Product C

FT21092 an electronic tobacco vapor product

OTHER

Product D

FT21018 an electronic tobacco vapor product

OTHER

Product E

4mg nicotine gum

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Charles Tomek, MD · Celerion

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
2017-04-17
Primary Completion
2017-05-25
Completion
2017-05-25

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 NCT03126357 on ClinicalTrials.gov