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Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking

NCT07625956 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

  • Smoking ( Cigarette)

Interventions

DRUG

Nicotine replacement therapy patches

Nicotine replacement therapy patches will be dosed based on current cigarette smoking at the end of the parent trial.

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.

Sponsors & Collaborators

Principal Investigators

  • Amanda Palmer, PhD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-26
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT07625956 on ClinicalTrials.gov