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

Primary Purpose

Tobacco Use Disorder, Oral Nicotine Pouch Use, Smoking Behaviors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ZYN
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tobacco Use Disorder

Eligibility Criteria

21 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3mg Nicotine Concentration

6mg Nicotine Concentration

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants who switched from cigarettes to the ZYN Pouches.
To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations
Change in levels of biomarkers (nicotine, NNAL, CO) among smokers
Participants will provide repeated lab samples for biomarker assessments. Urine and breath carbon monoxide samples will be obtained at baseline, week 4, and week 8 (only if complete switching is reported).
Number of cigarettes smoked per day.
The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations
Percentage of smoke free days.
The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations

Secondary Outcome Measures

Modified Cigarette Evaluation Scale
To evaluate the acceptability of switching, participants will rate ZYN and how it compares to their preferred cigarettes. Additionally, participants will also be asked how likely it is that they will continue to use ZYN compared to cigarettes. The investigators will utilize items modified from the Modified Cigarette Evaluation Scale adapted for these subjective measures. To evaluate the feasibility of switching to ZYN, we will document how many participants switch entirely to ZYN.

Full Information

First Posted
January 17, 2020
Last Updated
August 15, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04250727
Brief Title
Switching to Potential Reduced Exposure Products in Adult Smokers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Oral Nicotine Pouch Use, Smoking Behaviors, Harm Reduction, Toxic Effect of Tobacco and Nicotine, Carcinogenesis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3mg Nicotine Concentration
Arm Type
Experimental
Arm Description
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
Arm Title
6mg Nicotine Concentration
Arm Type
Experimental
Arm Description
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
Intervention Type
Device
Intervention Name(s)
ZYN
Intervention Description
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 Outcome Measure Information:
Title
Number of participants who switched from cigarettes to the ZYN Pouches.
Description
To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations
Time Frame
This will be evaluated at week 4.
Title
Change in levels of biomarkers (nicotine, NNAL, CO) among smokers
Description
Participants will provide repeated lab samples for biomarker assessments. Urine and breath carbon monoxide samples will be obtained at baseline, week 4, and week 8 (only if complete switching is reported).
Time Frame
from baseline up to week 4
Title
Number of cigarettes smoked per day.
Description
The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations
Time Frame
up to week 4
Title
Percentage of smoke free days.
Description
The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations
Time Frame
up to week 4
Secondary Outcome Measure Information:
Title
Modified Cigarette Evaluation Scale
Description
To evaluate the acceptability of switching, participants will rate ZYN and how it compares to their preferred cigarettes. Additionally, participants will also be asked how likely it is that they will continue to use ZYN compared to cigarettes. The investigators will utilize items modified from the Modified Cigarette Evaluation Scale adapted for these subjective measures. To evaluate the feasibility of switching to ZYN, we will document how many participants switch entirely to ZYN.
Time Frame
week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Switching to Potential Reduced Exposure Products in Adult Smokers

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