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

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ClinicalTrials.gov Identifier: NCT04250727
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Oral Nicotine Pouch Use Smoking Behaviors Harm Reduction Toxic Effect of Tobacco and Nicotine Carcinogenesis Device: ZYN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: 3mg Nicotine Concentration
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
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.

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




Primary Outcome Measures :
  1. Number of participants who switched from cigarettes to the ZYN Pouches. [ Time Frame: This will be evaluated at week 4. ]
    We will investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations

  2. Change in levels of biomarkers (nicotine, NNAL, CO) among smokers [ Time Frame: Change from baseline to week 4 will be assessed. ]
    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).


Secondary Outcome Measures :
  1. Modified Cigarette Evaluation Scale [ Time Frame: These assessments will occur at week 4. ]
    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. We 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.



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Ages Eligible for Study:   21 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 5 cigarettes per day for the past 6 months
  4. Expired breath carbon monoxide level ≥ 6ppm at baseline
  5. Not currently interested in smoking cessation services or quitting
  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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250727


Contacts
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Contact: Lisa Fucito, Ph.D. 203-200-1470 lisa.fucito@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Lisa Fucito, Ph.D.    203-200-1470    lisa.fucito@yale.edu   
Sponsors and Collaborators
Yale University
Publications:
Sobell, L., & Sobell, M. (1995). Alcohol consumption measures. In J. Allen & M. Columbus (Eds.), Assessing alcohol problems: A guide for clinicians and researcher (pp. 55-73). Bethesda, MD: National Institute on Alcohol Abuse & Alcoholism.
Sobell, L., & Sobell, M. (2003). Alcohol consumption measures. In J. P. A. a. V. B. & Wilson (Eds.), Assessing alcohol problems: A guide for clinicians and researchers. (pp. 75-99). Bethesda, MD: National Institute on Alcohol Abuse & Alcoholism.

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04250727    
Other Study ID Numbers: 2000023826
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinogenesis
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neoplastic Processes
Neoplasms
Pathologic Processes