Effects of tobacco-free oral nicotine pouches in smokers

Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers

This study tests how different flavors and amounts of tobacco-free nicotine pouches affect healthy adult smokers and their experience compared to their usual cigarettes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05335915 on ClinicalTrials.gov

What this trial studies

This study examines how different doses and flavors of tobacco-free oral nicotine pouches affect healthy adult smokers. Participants will engage in a double-blind, within-subjects design, where they will use various nicotine pouches and their preferred brand of cigarettes across multiple sessions. Blood samples will be collected to analyze nicotine pharmacokinetics, while subjective drug effects and withdrawal symptoms will also be assessed. Each participant will complete seven separate visits, with sessions spaced at least 48 hours apart.

Who should consider this trial

Good fit: Ideal candidates are healthy adult smokers aged 21 and older with a history of regular smoking and mild tobacco use disorder.

Not a fit: Patients who do not smoke or have not used tobacco products regularly may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into safer nicotine delivery methods that may help smokers manage withdrawal and addiction.

How similar studies have performed: Other studies have explored nicotine delivery methods, but this specific approach with tobacco-free pouches is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. ≥ 21 years old
2. good general health based on screening procedures (e.g., physical exam, blood testing)
3. vital signs in normal range (resting heart rate less than 100bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 90mmHg)
4. negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
5. self-report currently smoking daily
6. self-report at least a one year history of regular smoking
7. exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening
8. meet criteria for at least mild tobacco use disorder
9. no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days
10. no self-reported prior use of novel oral nicotine pouches
11. exhaled breath CO less than 10 ppm upon arrival for each study session.

Exclusion Criteria:

1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
2. Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigators or medical staff, will impact safety
3. Use of cannabis \>4 times per week
4. History of or current significant medical condition that, in the opinion of the investigators or medical staff, will impact safety
5. Current psychiatric condition or substance use disorder (aside from tobacco use disorder) that, in the opinion of the investigators or medical staff, will impact safety or study outcomes
6. Women who are pregnant, planning to become pregnant, or are breast-feeding
7. Currently seeking treatment to quit smoking or currently using a nicotine/tobacco cessation product.
8. Enrollment in another clinical trial in the past 30 days

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Tory Spindle, PhD — Johns Hopkins University
• Study coordinator: Tory Spindle, PhD

Conditions Nicotine Withdrawal; Nicotine Addiction; Drug Effect