Recruiting

Nicotine Pouches

Sponsor:

Medical University of South Carolina

Code:

NCT06678789

Conditions

Cigarette Smoking

Nicotine Dependence

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

High Nicotine Dose

Low Nicotine Dose

Study Details

Brief 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

Study ID

NCT06678789

Start date

Feb 14, 2025

Status verified date

Dec, 2025

Completion date

May 28, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 21+
  • current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes)
  • have not used TNFPs more than 5 times during their lifetime
  • willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)
  • have internet access

Exclusion Criteria:

  • Lack of proficiency in English.
  • Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.
  • Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).
  • Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.
  • Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: High Nicotine

High dosage nicotine pouches (6mg)

experimental: Low Nicotine

Low dosage nicotine pouches (3mg)

Interventions

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 \[70 tins\])

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 \[70 tins\])

Primary outcome measure

  • Switching [ Time Frame: Day 28 and Day 56 ]
  • Smoking Reduction [ Time Frame: Day 28 and Day 56 ]

Central Contacts and Locations

Central contacts

Talia Ogretman

843-259-8111ogretmet@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 20, 2026

Last verified

Dec, 2025

Keywords

  • Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.