Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking (Pack2Pouch+)

May 29, 2026 updated by: Amanda Palmer, Medical University of South Carolina
Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Universtiy of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 21 years or older
  • Currently enrolled in and completed the Pack2Pouch parent study
  • Current combustible tobacco smoking at extension study enrollment
  • Able to attend in-person visits in the Charleston, SC area
  • Access to internet and mobile communication

Exclusion Criteria:

  • Pregnancy, breastfeeding, or nursing
  • Medical contraindications to nicotine replacement therapy
  • Current use of smoking cessation medications
  • Non-English proficiency
  • Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Increase
Increase nicotine content of pouches
Drug: Oral nicotine pouches
Zyn oral nicotine pouches will be provided in the flavor preference of the participant and dosed based on their randomization in the parent trial and randomization in the extension study.
Active Comparator: Augment
Add nicotine replacement therapy
Drug: Nicotine replacement therapy patches
Nicotine replacement therapy patches will be dosed based on current cigarette smoking at the end of the parent trial.
No Intervention: Continue
Participants will continue with their treatment from the parent trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: Days 1-56
Feasibility endpoints include 1) the proportion of eligible subjects who subsequently enroll; 2) the proportion of enrolled subjects who complete the Day 28 and Day 56 assessments; and 3) the proportion of enrolled subjects who complete ≥80% of their daily surveys during the switching period.
Days 1-56
Acceptability
Time Frame: Day 28
Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM).
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Amanda Palmer, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00150364

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this study may be shared, by reasonable request, with other investigators not affiliated with the tobacco industry.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking ( Cigarette)

Clinical Trials on Oral nicotine pouches

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe