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Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes

NCT03559725 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-03-25

No results posted yet for this study

Summary

This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.

Conditions

  • Tobacco Use

Interventions

OTHER

VLN menthol cigarettes (A)

0.4mg nicotine / g tobacco king size filter menthol cigarette

OTHER

Usual Brand Menthol Cigarettes (B)

Usual brand king size menthol cigarettes

DRUG

Nicotine gum (C)

4 mg nicotine gum

Sponsors & Collaborators

  • Vince & Associates Clinical Research, Inc.

    collaborator OTHER

  • 22nd Century Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Debra Kelsh, MD · Vince and Associates Clinical Research, INC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-10-04
Completion
2018-10-04

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 NCT03559725 on ClinicalTrials.gov