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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07625956
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Smoking ( Cigarette)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Increase
    Increase nicotine content of pouches
  • Active Comparator: Augment
    Add nicotine replacement therapy
  • No Intervention: Continue
    Participants will continue with their treatment from the parent trial.

Primary Outcome Measure

Feasibility [ Time Frame: Days 1-56 ]

Locations (1)

FacilityCityStateZIP
Medical Universtiy of South CarolinaCharlestonSouth Carolina29425

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Medical Universtiy of South Carolina· Charleston, SC

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