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OpenTrials
Enrolling by Invitation

NCT Number: NCT07625956

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

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.

Enrolling by Invitation

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Key information

Conditions

Smoking ( Cigarette) Behavior Cigarette Smoking Smoking Tobacco Smoking Tobacco Use

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Universtiy of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Acceptability

    Time frame: Day 28

    Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM). This measure includes 4 items rated on scale of 1 to 5. Scores are created by averaging responses, with values ranging from 1 to 5. Higher values indicate higher acceptability.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: Pack2Pouch+

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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