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

NCT07625956 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: Pro00150364
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (2)

• Feasibility

  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

  Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM).

  Day 28

Study Arms (3)

Increase

ACTIVE COMPARATOR

Increase nicotine content of pouches

Drug: Oral nicotine pouches

Augment

ACTIVE COMPARATOR

Add nicotine replacement therapy

Drug: Nicotine replacement therapy patches

Continue

NO INTERVENTION

Participants will continue with their treatment from the parent trial.

Interventions

Nicotine replacement therapy patches DRUG

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

Augment

Oral nicotine pouches DRUG

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.

Increase

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical Universtiy of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Amanda Palmer, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor-Faculty

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)