Short-term effects of oral nicotine pouches

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This outpatient human laboratory study will enroll 60 daily cigarette smokers and 60 adult infrequent nicotine users who complete two counterbalanced experimental sessions at Johns Hopkins. The design is mixed between/within-subjects so each participant experiences both experimental conditions and serves as their own control. Sessions include pre-session requirements (smokers abstain from tobacco for 12 hours), administration of nicotine pouches, and repeated measures of subjective effects, cognitive performance, vital signs, and optional blood draws for pharmacokinetics. The goal is to characterize acute pharmacodynamic and pharmacokinetic responses and measures related to abuse liability in both frequent and infrequent users.

Why it matters

Who can join: the full rules

Inclusion criteria (all participants):

* greater than or equal to 21 years old
* good general health based on screening procedures
* vital signs in normal range (resting heart rate less than 110bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 100mmHg)
* negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
* no self-reported prior use of oral nicotine pouches
* Not actively trying to quit smoking or using smoking cessation medication (e.g., nicotine replacement therapy)

Additional inclusion criteria (smokers):

* self-report currently smoking cigarettes daily
* exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening
* meet criteria for tobacco use disorder
* no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days

Additional inclusion criteria (non-nicotine users):

* self-report previously using nicotine/tobacco but no more than 100 lifetime uses across all routes of administration
* no self-reported nicotine/tobacco uses in the past 30 days
* urine cotinine less than 100 ng/ml at screening.

Exclusion criteria (all participants):

* psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
* current use of OTC drugs, supplements/vitamins, or prescription medications that, in the opinion of medical staff, will impact safety
* currently have severe dependence for cannabis
* history of or current significant medical condition that, in the opinion of medical staff, will impact safety
* current psychiatric condition or substance use disorder (aside from tobacco use disorder for smokers), that, in the opinion of medical staff, will impact safety
* women who are pregnant, planning to become pregnant, or are breast-feeding

Where it's running

• Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Tory Spindle, PhD — Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences
• Study coordinator: Joseph Ciancio, PhD
• Email: jcianci3@jh.edu
• Phone: (410) 550-0529

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.