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Enrolling by invitation NCT07625956

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

Phase IV Interventional Smoking ( Cigarette)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicotine replacement therapy patches, Oral nicotine pouches.
Who it may be relevant to
Registry conditions: Smoking ( Cigarette). Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Feasibility [Time frame: Days 1-56]
  • Acceptability [Time frame: Day 28]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical Universtiy of South Carolina — Charleston

Identifiers

NCT: NCT07625956 · Pro00150364

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗