Health TrialsbyHealthPanel

Use of Nicotine Pouches Among Daily Smokers

ConditionTobacco Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorMilton S. Hershey Medical Center

About this trial

The purpose of this clinical trial is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. The main aims are:

1. Understand the impact of nicotine pouch use on toxicant exposure biomarkers, and indicators of potential harms to health. 2. Examine the influence of nicotine pouch use on conventional tobacco product use (cigarettes).

Participants will be randomized to one of six nicotine pouch groups (3 nicotine strengths, each with 2 potential flavors) to use over 16 weeks and asked to reduce their cigarette smoking over that time by at least 75% by substituting with the use of the nicotine pouches. Researchers will compare the outcomes of the different nicotine pouch strengths and flavors to each other. Participants will be asked to complete study questionnaires and provide urine, exhaled carbon monoxide, and mouth cell samples, and other health measurements.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Commonly smoke ≥ 5 cigarettes per day (at least 2 days/week) for at least the prior 12 months

Exhaled CO measurement of ≥ 6 parts per million at baseline

Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches

Able to understand, read and write in English

Disqualifiers

Plans to quit smoking within the next 30 days

Currently pregnant, breastfeeding, or planning to become pregnant in the next 6 months

Recent (past 3 months) unstable illness that may increase risks of participation or ability to participate fully (e.g. hospitalization for a mental health condition or substance use disorder in prior 6 months, stroke or myocardial infarction in the past year)

Serious current respiratory diseases (e.g. exacerbations of asthma or chronic obstructive pulmonary disease [COPD], requiring oxygen or oral prednisone), kidney disease (e.g. requiring dialysis), liver disease (e.g cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0 mg nicotine pouch

    Other intervention

    Oral nicotine pouches that contain 0 mg of nicotine

  • 3 mg nicotine pouch

    Other intervention

    Oral nicotine pouches that contain 3 mg of nicotine

  • 6 mg nicotine pouch

    Other intervention

    Oral nicotine pouches that contain 6 mg of nicotine

  • Smooth nicotine pouch

    Other intervention

    Non-flavored nicotine pouches that are characterized as smooth.

  • Wintergreen nicotine pouch

    Other intervention

    Menthol flavored nicotine pouches that are characterized as wintergreen.

Treatment groups

375 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 0 mg + Smooth flavorExperimental treatment 2 interventions
Group B: 3 mg + Smooth flavorExperimental treatment 2 interventions
Group C: 6 mg + Smooth flavorExperimental treatment 2 interventions
Group D: 0 mg + Wintergreen flavorExperimental treatment 2 interventions
Group E: 3 mg + Wintergreen flavorExperimental treatment 2 interventions
Group F: 6 mg + Wintergreen flavorExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Concentration of urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol)

Measure of tobacco-specific nitrosamine

Time frame
Week 16

Secondary outcomes

1

Level of carbon monoxide in exhaled breath

Measure of cigarette smoke exposure obtained with an exhaled carbon monoxide monitor

Time frame
Week 16
2

Concentration of urinary cotinine

Measure of nicotine exposure

Time frame
Week 16
3

Penn State Cigarette Dependence Index score

Measure of cigarette dependence via the Penn State Cigarette Dependence Index. Scale range is 0-20. Higher scores indicate more dependence.

Time frame
Week 16
4

Penn State Nicotine Pouch Dependence Index score

Measure of nicotine pouch dependence via the Penn State Nicotine Pouch Dependence Index. Scale range is 0-20. Higher scores indicate more dependence.

Time frame
Week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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