Switching to Potential Reduced Exposure Products in Adult Smokers

Not Applicable

Completed

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

• Registration Number: NCT04250727
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Start: 2021-05-01
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17
• Disposition First Submitted: 2023-08-15
• Results First Submitted: 2023-10-31
• Results First Submitted QC: 2024-02-27
• Results First Posted: 2024-03-26
• Disposition First Posted: 2024-03-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6mg Nicotine Concentration	ZYN	15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
3mg Nicotine Concentration	ZYN	15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.

Primary Outcome Measures

Name	Time	Method
Number of Cigarettes Smoked Per Day (Log-transformed)	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 Outcome Measures

Name	Time	Method
Subjective Effects of Oral Nicotine Pouches	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.
Level of Biomarker (NNAL) Among Smokers	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.
Percentage of Smoke Free Days.	up to week 4	The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations
Number of Participants Who Switched From Cigarettes to the ZYN Pouches.	This will be evaluated at week 4.	To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States