Acute Effects of Oral Nicotine Pouches

Johns Hopkins University

Status and phase: Not yet enrolling; Phase 1

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

Treatments: Drug: Nicotine Pouches

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07128329

IRB00502492

5R01DA055962-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

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).

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Pouch label version 1

Active Comparator group

Description:

Nicotine pouches with label 1

Treatment:

Drug: Nicotine Pouches

Pouch label version 2

Experimental group

Description:

Nicotine pouches with label 2

Treatment:

Drug: Nicotine Pouches