Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

NCT06678789 | Recruiting DMC

• 2 other identifiers: Pro001397105K12DA031794
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Smoking

Outcome Measures

Primary Outcomes (2)

• Switching

  Switching will be defined at 7-day point-prevalence biochemically-confirmed abstinence from cigarettes alongside self-reported use of nicotine pouches. Non-responders and missing data will be coded as smoking.

  Day 28 and Day 56

• Smoking Reduction

  Baseline and daily survey data will be used to calculate the change of smoking (average cigarettes per day) between groups from baseline to end of sampling.

  Day 28 and Day 56

Secondary Outcomes (1)

• Tobacco-Free Oral Nicotine Pouches (TFNP) Use

  Day 28

Study Arms (2)

High Nicotine

EXPERIMENTAL

High dosage nicotine pouches (6mg)

Behavioral: High Nicotine Dose

Low Nicotine

EXPERIMENTAL

Low dosage nicotine pouches (3mg)

Behavioral: Low Nicotine Dose

Interventions

Low Nicotine Dose BEHAVIORAL

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 \[70 tins\])

Low Nicotine

High Nicotine Dose BEHAVIORAL

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 \[70 tins\])

High Nicotine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Disorder; Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Study Officials

• Amanda Palmer, PhD.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Talia Ogretman

CONTACT

843-259-8111; ogretmet@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 7, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data and supporting information will be shared 1 year after study results are published.
• Access Criteria: Academic researchers who are not affiliated with or funded by the tobacco industry (including their consultants and non-profit organizations) may request access.

Locations

US (1)