Nicotine Pouch Self-AdministrationPhase 1NCT07128329
Acute Effects of Oral Nicotine Pouches
A Phase 1 study testing Nicotine Pouches in people with Nicotine Pouch Self-Administration and Nicotine Pharmacokinetic Study, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Pouch Self-Administration, Nicotine Pharmacokinetic Study, Nicotine Pharmacodynamic Study
- What is being tested?
- Nicotine Pouches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2025to 1 Apr 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)
Baltimore, Maryland, 21224
Joseph Ciancio, jcianci3@jh.edu
About this study
Official title: The Acute Effects of Oral Nicotine Pouches Among Infrequent and Frequent Nicotine/Tobacco Users
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).
Read the detailed description
This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 2 outpatient experimental sessions (separated by at least 48 hours). The study will use a mixed between/within-subjects crossover design. The between-subjects component is because there are two groups of participants (60 cigarette smokers, 60 infrequent nicotine users) and the within-subjects component is because participants complete all experimental sessions (thus, serving as the participant's own control). Smokers will be instructed to abstain from all tobacco 12 hours prior to each session so that the participants begin study sessions in a state of nicotine/tobacco withdrawal. Sessions will be completed in a counterbalanced order to reduce order effects. During each experimental session, a battery of assessments including subjective questionnaires (abuse liability, nicotine-related effects, withdrawal suppression), cognitive performance, blood collection for pharmacokinetic analysis (this will be optional), vital signs, and pouch use (or topography) will be conducted
- Conditions
- Nicotine Pouch Self-Administration, Nicotine Pharmacokinetic Study, Nicotine Pharmacodynamic Study
- Being tested
- Nicotine Pouches
- Keywords
- Nicotine pouch, Cigarette smokers, Infrequent nicotine users, Outpatient, Zyn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PouchesDrug
Also called Zyn
Nicotine pouches
| Study group | Role | What they receive |
|---|---|---|
| Pouch label version 1 | Active comparator | Nicotine pouches with label 1 Receives: Drug: Nicotine Pouches |
| Pouch label version 2 | Experimental | Nicotine pouches with label 2 Receives: Drug: Nicotine Pouches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - CMax for nicotine
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.
Measured: 6.5 hours
Pharmacokinetics - AUC for nicotine
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.
Measured: 6.5 hours
Drug Effect Questionnaire-Like Drug Effect
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.
Measured: 6.5 hours
Drug Effect Questionnaire-pleasant Drug Effect
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.
Measured: 6.5 hours
Drug Effect Questionnaire-take again
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.
Measured: 6.5 hours
Topography - number of pouches used
During the 2 hour ad libitum bout, primary topography variable will be collected - the total number of pouches used (range 0 - 5)
Measured: 2 hours
Topography - duration of use
During the 2 hour ad libitum bout, primary topography variable will be collected - total duration of use (range 0 - 2 hours).
Measured: 2 hours
Hughes-Hatsukami Withdrawal Questionnaire
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.
Measured: 6.5 hours
Tiffany-Drobes Questionnaire on Smoking Urges (QSU) brief
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.
Measured: 6.5 hours
Secondary outcomes (5)
Pharmacokinetics - Tmax for nicotine
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Time to max concentration (Tmax), is the time (in min) to reach Cmax. This is another measure relevant for abuse liability. Range is 0 - 20 min for directed period
Measured: 6.5 hours
The Direct Effects of Nicotine Scale (DENS)
The DENS will assess nicotine-specific effects via 10 items "Confused," "Dizzy," "Headache," "Heart Pound," "Lightheaded," "Nauseous," "Nervous," "Salivation," "Sweaty," and "Weak". Each item is scored separately from 0 (not at all) to 100 (extremely).
Measured: 6.5 hours
Drug Effects Questionnaire (DEQ) - feel drug effect
The DEQ will assess subjective ratings for "feel drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: 6.5 hours
Drug Effects Questionnaire (DEQ) subjective effects- unpleasant effect
The DEQ will assess subjective ratings for "unpleasant drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: 6.5 hours
Drug Effects Questionnaire (DEQ) subjective effects- dislike drug effect
The DEQ will assess subjective ratings for "dislike drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: 6.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2025
- Study start21 Nov 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Pouch Self-AdministrationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Mixed between/within-subjects crossover design with two groups of participants (cigarette smokers and infrequent nicotine users). Participants complete all experimental sessions, serving as their own control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tory Spindle, PhD, Principal investigator, Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128329
- Sponsor's protocol ID
- IRB00502492
- Other IDs
- 5R01DA055962-04
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No