Actively Recruiting
Acute Effects of Oral Nicotine Pouches
Led by Johns Hopkins University · Updated on 2026-02-17
120
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Acute Effects of Oral Nicotine Pouches
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 21 years of age or older
- Good general health based on screening
- Resting heart rate less than 110 bpm
- Systolic blood pressure less than 150 mmHg
- Diastolic blood pressure less than 100 mmHg
- Negative urine test for illicit drugs (except THC) and negative breath alcohol test at screening and before sessions
- No prior use of oral nicotine pouches
- Not actively trying to quit smoking or using cessation medications
- For smokers: currently smoking cigarettes daily
- For smokers: exhaled breath CO ≥ 10 ppm and urine cotinine > 100 ng/ml at screening
- For smokers: meet tobacco use disorder criteria
- For smokers: no regular use of other tobacco products in past 30 days
- For non-nicotine users: previous nicotine/tobacco use fewer than 100 times lifetime
- For non-nicotine users: no nicotine/tobacco use in past 30 days
- For non-nicotine users: urine cotinine less than 100 ng/ml at screening
You will not qualify if you...
- Psychoactive drug use (other than cannabis, nicotine, alcohol, caffeine) in past month
- Current use of medications or supplements that may affect safety
- Severe cannabis dependence
- Significant medical conditions affecting safety
- Current psychiatric condition or substance use disorder (except tobacco use disorder for smokers) affecting safety
- Women who are pregnant, planning pregnancy, or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
J
Joseph Ciancio, PhD
CONTACT
L
Lakshmi Kumar, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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