MedTrace Logo

Modern Nicotine Oral Product Abuse Liability

NCT06777784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-23

No results posted yet for this study

Summary

This is a two-site, open-label, randomized, 8-way 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 smokers.

Conditions

  • Smoking
  • Tobacco Use

Interventions

OTHER

Product C

Modern Nicotine Oral Product Cool Mint 12 mg Nicotine

OTHER

Product D

Modern Nicotine Oral Product Cool Mint 15 mg Nicotine

OTHER

Product E

Modern Nicotine Oral Product Smooth 6 mg Nicotine

OTHER

Product F

Modern Nicotine Oral Product Wintergreen 6 mg Nicotine

OTHER

Product G

Modern Nicotine Oral Product Dragon Fruit 6 mg Nicotine

OTHER

Product N

Nicorette® White Ice Mint 4 mg nicotine gum

OTHER

Product A

Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette

OTHER

Product B

Modern Nicotine Oral Product Cool Mint 6 mg Nicotine

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Brian Keyser, PhD · Reynolds American

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
2025-02-03
Primary Completion
2025-03-05
Completion
2025-03-05

Countries

  • United States

Study Locations

More Related Trials

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 NCT06777784 on ClinicalTrials.gov