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

Conditions

Nicotine Withdrawal Nicotine Addiction Drug Effect

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-27

Study Completion:2025-08-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05335915

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Tory Spindle, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Tory Spindle, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-27

Study Completion Date2025-08-29

Study Record Updates

Study Start Date2022-07-27

Study Completion Date2025-08-29

Terms related to this study

Additional Relevant MeSH Terms

Nicotine Withdrawal
Nicotine Addiction
Drug Effect