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

Description

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.

Conditions

Nicotine Withdrawal, Nicotine Addiction, Drug Effect

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Nicotine Withdrawal
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Johns Hopkins University,

Tory Spindle, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-09-01