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RecruitingAccepts healthy volunteersPhase 1

Acute Effects of Oral Nicotine Pouches

Johns Hopkins University · with National Institute on Drug Abuse (NIDA) · NCT07128329

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
120
US sites recruiting
1
Study start
November 21, 2025
Record last updated
February 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: Nicotine Pouches

Conditions: Nicotine Pouch Self-Administration; Nicotine Pharmacokinetic Study; Nicotine Pharmacodynamic Study

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)

    Baltimore, MD 21224

    Site contact: Joseph Ciancio · jcianci3@jh.edu

Study contacts (from the official record)

  • Joseph Ciancio, PhD · (410) 550-0529 · jcianci3@jh.edu
  • Lakshmi Kumar, PhD · (410) 550-1928 · lkumar6@jh.edu
Acute Effects of Oral Nicotine Pouches (NCT07128329) | Bored Studies