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CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems

NCT04094363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-27

No results posted yet for this study

Summary

This is a randomized, open-label, crossover study designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the investigational products (IPs) by healthy subjects.

Conditions

  • Smoking
  • Tobacco Smoking
  • Tobacco Use

Interventions

OTHER

Product A

Usual Brand, filtered combustible cigarette

OTHER

Product B

CSD1902-11, an electronic nicotine delivery system

OTHER

Product C

CSD1902-21, an electronic nicotine delivery system

OTHER

Product D

4mg Nicotine gum

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • 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
2019-10-03
Primary Completion
2019-11-26
Completion
2019-11-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04094363 on ClinicalTrials.gov