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CSD190401: A Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products

NCT04372290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-09-25

No results posted yet for this study

Summary

This is a single site, open-label, randomized, cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.

Conditions

  • Smoking
  • Smoking Behaviors
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

Product A

Usual brand (UB) filtered, combustible cigarette

OTHER

Product B

Nicorette® White Ice Mint 2 mg nicotine gum

OTHER

Product C

CSD1904-01, a nicotine pouch, 2 mg nicotine

OTHER

Product D

CSD1904-02, a nicotine pouch, 4 mg nicotine

OTHER

Product E

CSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches)

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Bobbette Jones, DrPH · 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
2020-05-06
Primary Completion
2020-06-04
Completion
2020-06-04

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 NCT04372290 on ClinicalTrials.gov