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Completed

NCT Number: NCT04250727

Switching to Potential Reduced Exposure Products in Adult Smokers

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.

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Key information

Conditions

Tobacco Use Disorder Behavior Carcinogenesis Chemically-Induced Disorders Harm Reduction Mental Disorders Neoplasms Neoplastic Processes Oral Nicotine Pouch Use Pathologic Processes Pathological Conditions, Signs and Symptoms Smoking Smoking Behaviors Substance-Related Disorders Toxic Effect of Tobacco and Nicotine

Age range

21 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
  • English literate
  • Smoke at least 1 cigarette per day
  • Expired breath carbon monoxide level ≥ 6ppm at baseline
  • Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month
  • Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).

Exclusion criteria

  • Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
  • History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
  • Current uncontrolled medical condition
  • Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation)
  • Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study
  • Severe lung disease that requires supplemental oxygen
  • Uncontrolled asthma (<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
  • Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
  • Planning to quit smoking with a set goal or time for quit attempt
  • Known hypersensitivity to propylene glycol
  • Patients with an FEV1 < 40%

Treatment and study plan

ZYN

Device

30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

Primary outcomes

  1. Number of Cigarettes Smoked Per Day (Log-transformed)

    Time frame: up to week 4

    The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.

Secondary outcomes

  1. Number of Participants Who Switched From Cigarettes to the ZYN Pouches.

    Time frame: This will be evaluated at week 4.

    To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations

  2. Percentage of Smoke Free Days.

    Time frame: up to week 4

    The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations

  3. Level of Biomarker (NNAL) Among Smokers

    Time frame: baseline and week 4

    Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time.

  4. Subjective Effects of Oral Nicotine Pouches

    Time frame: week 4

    To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History

Acronym: ZYN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2020
Registry last updated
May 1, 2024

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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