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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

Summary

This trial is testing if adult smokers would be willing to switch to oral nicotine pouches and if doing so reduces harm compared to smoking cigarettes. The study will measure changes in smoking behavior and exposure to harmful substances when using these pouches. Tobacco-free oral nicotine pouches have emerged as a potential reduced risk product compared with cigarettes and other tobacco products.

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

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

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

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

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Who is running the clinical trial?

Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,019,019 Total Patients Enrolled
54 Trials studying Tobacco Use Disorder
10,206 Patients Enrolled for Tobacco Use Disorder
~7 spots leftby Sep 2025
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