Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers (NCT05335915) | Clinical Trial Compass
CompletedPhase 1
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
United States71 participantsStarted 2022-07-27
Plain-language 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 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics of Nicotine as Assessed by the Cmax (20-min Directed Bout)
Timeframe: 0 to 1 hour
2
Pharmacokinetics of Nicotine as Assessed by the AUC (20 Min Directed Bout)
Timeframe: 0 to 1 hour
3
Peak Change From Baseline Subjective Ratings of "Like Drug Effect" as Assessed by the Drug Effect Questionnaire
Timeframe: Up to 6.5 hours
4
Subjective Ratings of "Pleasant Drug Effect" as Assessed by the Drug Effect Questionnaire
Timeframe: Up to 6.5 hours
5
Subjective Ratings of "Take Again" as Assessed by the Drug Effect Questionnaire
Timeframe: Up to 6.5 hours
6
Subjective Ratings of "Urge to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
Timeframe: Up to 6.5 hours
7
Subjective Ratings of "Craving to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
. meet criteria for at least mild tobacco use disorder
Exclusion criteria
. 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