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Nicotine Pouches

ZYN for Tobacco Use Disorder (ZYN Trial)

N/A
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights

ZYN Trial Summary

This trial will study the feasibility of smokers switching to oral nicotine pouches as a harm-reduction method. It will survey smokers' interest in switching to e-cigarettes or alternative non-combustible products, and then study a group of 30 smokers who switch to different concentrations of oral nicotine pouches. The study will measure changes in smoking behavior and biomarkers of tobacco exposure to assess the potential for harm reduction.

Eligible Conditions
  • Tobacco Use Disorder
  • Oral Nicotine Pouch Use
  • Smoking
  • Self-Harm
  • Tobacco/Nicotine Poisoning
  • Cancer

ZYN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Cigarettes Smoked Per Day (Log-transformed)
Secondary outcome measures
Change in Level of Biomarker (NNAL) Among Smokers
Number of Participants Who Switched From Cigarettes to the ZYN Pouches.
Percentage of Smoke Free Days.
+1 more

ZYN Trial Design

2Treatment groups
Experimental Treatment
Group I: 6mg Nicotine ConcentrationExperimental Treatment1 Intervention
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
Group II: 3mg Nicotine ConcentrationExperimental Treatment1 Intervention
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZYN
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,531 Total Patients Enrolled
54 Trials studying Tobacco Use Disorder
10,206 Patients Enrolled for Tobacco Use Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
Connecticut
How old are they?
18 - 65
What site did they apply to?
Yale University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
Journal of Clinical EpidemiologyJournal
PROMIS Fatigue Item Bank Had Clinical Validity Across Diverse Chronic Conditions
Cella, David, Jin-Shei Lai, Sally E. Jensen, Christopher Christodoulou, Doerte U. Junghaenel, Bryce B. Reeve, and Arthur A. Stone. 2016. “PROMIS Fatigue Item Bank Had Clinical Validity Across Diverse Chronic Conditions”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2015.08.037.
Addictive BehaviorsJournal
Gender Differences in Satisfaction Ratings for Nicotine Electronic Cigarettes by First-time Users
Grace, Randolph C., Bronwyn M. Kivell, and Murray Laugesen. 2015. “Gender Differences in Satisfaction Ratings for Nicotine Electronic Cigarettes by First-time Users”. Addictive Behaviors. Elsevier BV. doi:10.1016/j.addbeh.2015.06.027.
Signal Transduction and Targeted TherapyJournal
The Role of Micrornas in Human Cancer
Peng, Yong, and Carlo M Croce. 2016. “The Role of Micrornas in Human Cancer”. Signal Transduction and Targeted Therapy. Springer Science and Business Media LLC. doi:10.1038/sigtrans.2015.4.
CA: A Cancer Journal for CliniciansJournal
The First Surgeon General's Report on Smoking and Health: The 50th Anniversary
Brawley, Otis W., Thomas J. Glynn, Fadlo R. Khuri, Richard C. Wender, and John R. Seffrin. 2013. “The First Surgeon General's Report on Smoking and Health: The 50th Anniversary”. CA: A Cancer Journal for Clinicians. Wiley. doi:10.3322/caac.21210.
~7 spots leftby May 2025
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