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Acute Effects of Oral Nicotine Pouches

NCT07128329 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-17

No results posted yet for this study

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).

Conditions

  • Nicotine Pouch Self-Administration
  • Nicotine Pharmacokinetic Study
  • Nicotine Pharmacodynamic Study

Interventions

DRUG

Nicotine Pouches

Nicotine pouches

Sponsors & Collaborators

Principal Investigators

  • Tory Spindle, PhD · Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-21
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128329 on ClinicalTrials.gov