Acute Effects of Oral Nicotine Pouches

NCT ID: NCT07128329

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-21
• Study Completion Date: 2027-04-01

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).

Detailed Description

This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 2 outpatient experimental sessions (separated by at least 48 hours). The study will use a mixed between/within-subjects crossover design. The between-subjects component is because there are two groups of participants (60 cigarette smokers, 60 infrequent nicotine users) and the within-subjects component is because participants complete all experimental sessions (thus, serving as the participant's own control). Smokers will be instructed to abstain from all tobacco 12 hours prior to each session so that the participants begin study sessions in a state of nicotine/tobacco withdrawal. Sessions will be completed in a counterbalanced order to reduce order effects. During each experimental session, a battery of assessments including subjective questionnaires (abuse liability, nicotine-related effects, withdrawal suppression), cognitive performance, blood collection for pharmacokinetic analysis (this will be optional), vital signs, and pouch use (or topography) will be conducted

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Pouch label version 1

Nicotine pouches with label 1

Group Type: ACTIVE_COMPARATOR

Nicotine Pouches

Intervention Type: DRUG

Nicotine pouches

Pouch label version 2

Nicotine pouches with label 2

Group Type: EXPERIMENTAL

Nicotine Pouches

Intervention Type: DRUG

Nicotine pouches

Interventions

Nicotine Pouches

Nicotine pouches

Intervention Type: DRUG

Other Intervention Names

Zyn

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tory Spindle, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences

Locations

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

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph Ciancio, PhD

Role: CONTACT

jcianci3@jh.edu

(410) 550-0529

Lakshmi Kumar, PhD

Role: CONTACT

lkumar6@jh.edu

(410) 550-1928

Facility Contacts

Joseph Ciancio

Role: primary

jcianci3@jh.edu

Other Identifiers

5R01DA055962-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00502492

Identifier Type: -

Identifier Source: org_study_id