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

Launched by JOHNS HOPKINS UNIVERSITY · Apr 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of "tobacco-free" oral nicotine pouches on smokers. Researchers want to understand how different flavors and doses of these pouches compare to regular cigarettes in helping with nicotine withdrawal and addiction. If you are a healthy adult smoker aged 21 or older, have been smoking regularly for at least a year, and meet certain health criteria, you might be eligible to participate.

During the study, participants will try different nicotine pouches in various flavors (like tobacco, mint, and fruit) at low and high doses, as well as smoke their preferred brand of cigarettes. Each participant will take part in multiple sessions, using one product at a time under controlled conditions. While this trial is focused on gathering important information about these nicotine pouches, please note that participants cannot be using other tobacco products or currently trying to quit smoking. Overall, this study aims to explore new options for people who struggle with nicotine addiction in a safe and structured environment.

Gender

ALL

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