Short-term effects of oral nicotine pouches
The Acute Effects of Oral Nicotine Pouches Among Infrequent and Frequent Nicotine/Tobacco Users
PHASE1 · Johns Hopkins University · NCT07128329
Researchers will try oral nicotine pouches with adult daily cigarette smokers and adults who rarely use nicotine to see short-term effects on mood, thinking, and nicotine levels.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07128329 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 21 or older in good general health who are either daily cigarette smokers meeting biochemical criteria or adults who rarely use nicotine, with no prior use of oral nicotine pouches and not actively trying to quit smoking.
Not a fit: People under 21, those with unstable medical or cardiovascular conditions, pregnant people, current users of nicotine pouches or other regular tobacco products, or those using smoking cessation medications are unlikely to qualify or benefit directly from participation.
Why it matters
Potential benefit: If successful, the results could help regulators and clinicians understand how nicotine pouches affect users and inform safer product guidance or recommendations for people who smoke.
How similar studies have performed: Prior laboratory studies of oral nicotine products and nicotine replacement have shown measurable nicotine absorption and effects on craving and cognition, but controlled data specifically on commercial nicotine pouches remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nicotine Pouch Self-Administration, Nicotine Pharmacokinetic Study, Nicotine Pharmacodynamic Study, Nicotine pouch, Cigarette smokers, Infrequent nicotine users, Outpatient, Zyn