Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

NCT ID: NCT06678789

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2027-02-28

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.

Detailed Description

The proposed research project evaluates the potential for tobacco-free oral nicotine pouches (TFNPs) to serve as harm reduction tools at two nicotine concentrations, inclusive of behavioral and biomarker outcomes, using a clinical trial design. Specifically, in a randomized pilot study, participants who smoke will be recruited and sent TFNPs to sample for 4 weeks in either high (6 mg) or low (3 mg) nicotine content strengths. Participants will report tobacco use behaviors and submit biological samples throughout the study. This design allows for evaluation of the effect of nicotine content within alternative, harm-reducing tobacco products on key outcomes including: 1) complete switching from cigarette smoking to non-cigarette product use; 2) cigarette smoking reduction; 3) changes in biomarkers of harm (DNA damage, respiratory symptoms), 4) nicotine dependence, and 5) subjective effects of product use.

Conditions

Cigarette Smoking; Nicotine Dependence; Smoking Cessation

Keywords

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High Nicotine

High dosage nicotine pouches (6mg)

Group Type: EXPERIMENTAL

High Nicotine Dose

Intervention Type: 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 \[70 tins\])

Low Nicotine

Low dosage nicotine pouches (3mg)

Group Type: EXPERIMENTAL

Low Nicotine Dose

Intervention Type: 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 \[70 tins\])

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 \[70 tins\])

Intervention Type: 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 \[70 tins\])

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Palmer, PhD.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Talia Ogretman

Role: CONTACT

Phone: 843-259-8111

Email: ogretmet@musc.edu

Other Identifiers

5K12DA031794

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00139710

Identifier Type: -

Identifier Source: org_study_id