NCT07128329 Acute Effects of Oral Nicotine Pouches
| NCT ID | NCT07128329 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Nicotine Pouch Self-Administration |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2025-11-21 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present human laboratory study will recruit cigarette smokers (n=60) and adult infrequent nicotine users (n=60) to complete two counterbalanced lab sessions in which the participants use nicotine pouches under controlled conditions. The investigators are recruiting both frequent and infrequent nicotine users because FDA regulates tobacco products based on a public health standard, meaning FDA must consider the impact a regulation may have on the population as a whole (e.g., people who use and do not use tobacco products currently).
Eligibility 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
Contact & Investigator
Tory Spindle, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences
Frequently Asked Questions
Who can join the NCT07128329 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Nicotine Pouch Self-Administration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07128329 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07128329 currently recruiting?
Yes, NCT07128329 is actively recruiting participants. Contact the research team at jcianci3@jh.edu for enrollment information.
Where is the NCT07128329 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07128329 clinical trial?
NCT07128329 is sponsored by Johns Hopkins University. The principal investigator is Tory Spindle, PhD at Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences. The trial plans to enroll 120 participants.