Tobacco UseNCT05280769
Effects of an Oral Nicotine Product in Smokeless Tobacco Users
A study testing oral nicotine pouch - 2 mg, oral nicotine pouch - 4 mg and oral nicotine pouch - 8 mg in people with Tobacco Use, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- oral nicotine pouch - 2 mg, oral nicotine pouch - 4 mg and oral nicotine pouch - 8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (determined by self-report)
- Between the ages of 18-55
- Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required
- Agree to use designated products according to study protocol
- Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use
Who cannot join
- The following self-reported current, diagnosed medical condition(s): heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
- Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations
- Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use
- Not providing answers to questions related to inclusion/exclusion criteria
- Breast-feeding or pregnant women (pregnancy tested by urinalysis at screening
- Weigh less than 110 pounds
- Intend to quit tobacco/nicotine use in the next 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.
- Conditions
- Tobacco Use
- Being tested
- oral nicotine pouch - 2 mg, oral nicotine pouch - 4 mg, oral nicotine pouch - 8 mg, Smokeless tobacco
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nicotine pouch - 2 mgOther
"On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor
oral nicotine pouch - 4 mgOther
"On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor
oral nicotine pouch - 8 mgOther
"On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor
Smokeless tobaccoOther
Participant's typical brand of smokeless tobacco
| Study group | Role | What they receive |
|---|---|---|
| Single arm design | Experimental | On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. Receives: Other: oral nicotine pouch - 2 mg; Other: oral nicotine pouch - 4 mg; Other: oral nicotine pouch - 8 mg; Other: Smokeless tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma nicotine concentration
Blood will be taken multiple times in each session to assess the extent to which product use changes plasma nicotine levels compared to baseline
Measured: Baseline to the end of the session, approximately 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start23 Aug 2022
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alison Breland, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280769
- Sponsor's protocol ID
- HM20018418
- Other IDs
- U54DA036105
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Oral Nicotine Product in Smokeless Tobacco Users
- ClinicalTrials.gov ID
- NCT05280769
- Acronym / sponsor ID
- HM20018418
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study
| Arm | Type | Receives |
|---|---|---|
| Single arm design | Experimental | Other: oral nicotine pouch - 2 mg, Other: oral nicotine pouch - 4 mg, Other: oral nicotine pouch - 8 mg, Other: Smokeless tobaccoOn four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy (determined by self-report)
- Between the ages of 18-55
- Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required
- Agree to use designated products according to study protocol
- Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use
Key exclusion criteria (7 listed)
- The following self-reported current, diagnosed medical condition(s): heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
- Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations
- Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use
- Not providing answers to questions related to inclusion/exclusion criteria
- Breast-feeding or pregnant women (pregnancy tested by urinalysis at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral nicotine pouch - 2 mg"On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor | Other | Single arm design |
| oral nicotine pouch - 4 mg"On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor | Other | Single arm design |
| oral nicotine pouch - 8 mg"On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor | Other | Single arm design |
| Smokeless tobaccoParticipant's typical brand of smokeless tobacco | Other | Single arm design |
Primary outcome
Change in Plasma nicotine concentration
Time frame: Baseline to the end of the session, approximately 4 hours
Blood will be taken multiple times in each session to assess the extent to which product use changes plasma nicotine levels compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Breland, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nicotine pouch - 2 mg, oral nicotine pouch - 4 mg and oral nicotine pouch - 8 mg in people with Tobacco Use, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma nicotine concentration (time frame: Baseline to the end of the session, approximately 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.