NCT07128329 · Johns Hopkins University
Acute Effects of Oral Nicotine Pouches
What this study is about
The present human laboratory study will recruit cigarette smokers (n=60) and adult infrequent nicotine users (n=60) to complete two counterbalanced lab sessions in which the participants use nicotine pouches under controlled conditions.
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The present human laboratory study will recruit cigarette smokers (n=60) and adult infrequent nicotine users (n=60) to complete two counterbalanced lab sessions in which the participants use nicotine pouches under controlled conditions. The investigators are recruiting both frequent and infrequent nicotine users because FDA regulates tobacco products based on a public health standard, meaning FDA must consider the impact a regulation may have on the population as a whole (e.g., people who use and do not use tobacco products currently).
Interventions
DRUG
Nicotine Pouches
Nicotine pouches
Primary outcome measures
Pharmacokinetics - CMax for nicotine
Time frame: 6.5 hours
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product.
Pharmacokinetics - AUC for nicotine
Time frame: 6.5 hours
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Area under the curve (AUC), represents the total nicotine exposure during an entire session and provides important insight into the abuse liability of a tobacco product.
Drug Effect Questionnaire-Like Drug Effect
Time frame: 6.5 hours
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire-pleasant Drug Effect
Time frame: 6.5 hours
The DEQ will be used to obtain subjective ratings of "pleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire-take again
Time frame: 6.5 hours
The DEQ will be used to obtain subjective ratings of "take again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Topography - number of pouches used
Time frame: 2 hours
During the 2 hour ad libitum bout, primary topography variable will be collected - the total number of pouches used (range 0 - 5)
Topography - duration of use
Time frame: 2 hours
During the 2 hour ad libitum bout, primary topography variable will be collected - total duration of use (range 0 - 2 hours).
Hughes-Hatsukami Withdrawal Questionnaire
Time frame: 6.5 hours
The HHWS will be used to obtain subjective ratings of tobacco withdrawal outcomes among smokers including: "urge", "craving" "Anxious," "Depression," " Difficultly concentrating," "Drowsy," "Hunger," "Impatient," "Irritable," "Restlessness," "Desire for sweets". Scores for these items range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Tiffany-Drobes Questionnaire on Smoking Urges (QSU) brief
Time frame: 6.5 hours
The QSU-brief will measure tobacco withdrawal symptoms in smokers using 10 items that form 2 factors: factor 1 (intention to smoke) and factor 2 (anticipation of withdrawal symptom relief). Mean score 0-5. Lower score is better.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (all participants):
- greater than or equal to 21 years old
- good general health based on screening procedures
- vital signs in normal range (resting heart rate less than 110bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 100mmHg)
- negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
- no self-reported prior use of oral nicotine pouches
- Not actively trying to quit smoking or using smoking cessation medication (e.g., nicotine replacement therapy) Additional inclusion criteria (smokers):
- self-report currently smoking cigarettes daily
- exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening
- meet criteria for tobacco use disorder
- no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days Additional inclusion criteria (non-nicotine users):
- self-report previously using nicotine/tobacco but no more than 100 lifetime uses across all routes of administration
- no self-reported nicotine/tobacco uses in the past 30 days
- urine cotinine less than 100 ng/ml at screening.
Exclusion criteria
- (all participants):
- psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- current use of OTC drugs, supplements/vitamins, or prescription medications that, in the opinion of medical staff, will impact safety
- currently have severe dependence for cannabis
- history of or current significant medical condition that, in the opinion of medical staff, will impact safety
- current psychiatric condition or substance use disorder (aside from tobacco use disorder for smokers), that, in the opinion of medical staff, will impact safety
- women who are pregnant, planning to become pregnant, or are breast-feeding
Where
- Baltimore, Maryland
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations