MedTrace Logo

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

NCT06678789 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-18

No results posted yet for this study

Summary

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

  • Cigarette Smoking
  • Nicotine Dependence
  • Smoking Cessation

Interventions

BEHAVIORAL

High Nicotine Dose

Will receive a 5-week supply of 6 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day \[70 tins\])

BEHAVIORAL

Low Nicotine Dose

Will receive a 5-week supply of 3 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day \[70 tins\])

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Amanda Palmer, PhD. · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2026-08-01
Completion
2027-02-28

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 NCT06678789 on ClinicalTrials.gov