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

Completed · Phase 1

Conditions studied: Nicotine Withdrawal, Nicotine Addiction, Drug Effect

In brief

The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosing conditions: tobacco-flavored pouch (low or high nicotine dose), mint/menthol-flavored pouch (low or high nicotine dose), and fruit-flavored pouch (low or high nicotine dose); participants will also complete a condition where the participants will smoke participants' preferred brand of cigarettes. In each experimental session, participants will complete 2 product-use bouts. In bout 1, the participants will use a single product (pouch or cigarette) for a fixed period under controlled conditions. In bout 2, participants will be given 2 hours to use participants' assigned product ad libitum.

Key facts

Study ID

NCT05335915

Run by

Johns Hopkins University

People needed

71

Starts

2022-07-27

Expected to finish

2025-08-29

Last updated by the study team

2026-07-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
• 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
• Use of cannabis >4 times per week
• History of or current significant medical condition that, in the opinion of the investigators or medical staff, will impact safety
• 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
• Women who are pregnant, planning to become pregnant, or are breast-feeding
• Currently seeking treatment to quit smoking or currently using a nicotine/tobacco cessation product.
• Enrollment in another clinical trial in the past 30 days

Where it is running

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

Full record on ClinicalTrials.gov

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