Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
NCT06678789

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

Led by Medical University of South Carolina · Updated on 2025-12-18

50

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

CONDITIONS

Official Title

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 or older
  • Current cigarette smoking on 25 or more days in the past month
  • Smoking 5 or more cigarettes per day for more than 1 year
  • Smoked more than 100 cigarettes in lifetime
  • Have not used tobacco-free nicotine pouches more than 5 times
  • Willing and able to attend 2 in-person visits in Charleston
  • Have internet access
Not Eligible

You will not qualify if you...

  • Not proficient in English
  • Used other combustible tobacco products or non-combusted nicotine products in past 30 days
  • Currently using smoking cessation medications
  • Used marijuana in past month and unwilling to abstain during study
  • Medical conditions that contraindicate nicotine replacement therapy (including pregnancy, breastfeeding, recent heart attack, untreated heart rhythm problems, severe angina, severe vascular disease)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

T

Talia Ogretman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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