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New treatment option for Nicotine Pouch Self-Administration
Official title Acute Effects of Oral Nicotine Pouches
ClinicalTrials.gov ID: NCT07128329
What this study is testing
What is Nicotine Pouches?
Nicotine Pouches is an investigational medicine, being studied as a potential treatment for nicotine pouch self-administration.
Also referred to as Zyn.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- (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...
- negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
You likely can't join if
- (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...
See the full eligibility 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 (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 (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.
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.