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A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.

NCT03692078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2024-11-25

Study results available
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Summary

The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.

Conditions

  • Tobacco Use

Interventions

OTHER

OTDN product 1

Oral tobacco-derived nicotine product

OTHER

OTDN product 2

Oral tobacco-derived nicotine product

OTHER

Tobacco Cessation

Tobacco Cessation

Sponsors & Collaborators

  • Altria Client Services LLC

    lead INDUSTRY

Principal Investigators

  • Georgios D Karles, PhD · Altria Client Services LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2018-10-01
Completion
2018-10-01

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 NCT03692078 on ClinicalTrials.gov