Status:
COMPLETED
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Withdrawal
Nicotine Addiction
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- ≥ 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05335915
Start Date
July 27 2022
End Date
August 29 2025
Last Update
September 5 2025
Active Locations (1)
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1
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224