Switching to Potential Reduced Exposure Products in Adult Smokers

Tobacco Use Disorder Clinical Trial

— ZYN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250727
• Other study ID #: 2000023826
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 17, 2022

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 77 Years

Eligibility

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%

Related Conditions & MeSH terms

• Carcinogenesis
• Harm Reduction
• Oral Nicotine Pouch Use
• Smoking Behaviors
• Tobacco Use Disorder
• Toxic Effect of Tobacco and Nicotine

Intervention

Device:
• ZYN
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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cigarettes Smoked Per Day (Log-transformed)	The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.	up to week 4
Secondary	Number of Participants Who Switched From Cigarettes to the ZYN Pouches.	To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations	This will be evaluated at week 4.
Secondary	Percentage of Smoke Free Days.	The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations	up to week 4
Secondary	Change in Level of Biomarker (NNAL) Among Smokers	Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained at baseline and week 4 will be compared.	from baseline up to week 4
Secondary	Subjective Effects of Oral Nicotine Pouches	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.	week 4