Switching to Potential Reduced Exposure Products in Adult Smokers (ZYN)

Yale University

Status: Completed

Conditions: Tobacco Use Disorder; Toxic Effect of Tobacco and Nicotine; Harm Reduction; Smoking Behaviors; Carcinogenesis; Oral Nicotine Pouch Use

Treatments: Device: ZYN

Study type: Interventional

Funder types: Other

Identifiers

NCT04250727

2000023826

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
2. History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
3. Current uncontrolled medical condition
4. 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)
5. 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
6. Severe lung disease that requires supplemental oxygen
7. Uncontrolled asthma (<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
8. Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
9. Planning to quit smoking with a set goal or time for quit attempt
10. Known hypersensitivity to propylene glycol
11. Patients with an FEV1 < 40%

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

3mg Nicotine Concentration

Experimental group

Description:

15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.

Treatment:

Device: ZYN

6mg Nicotine Concentration

Experimental group

Description:

15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.

Treatment:

Device: ZYN