Electronic Cigarette UseNCT03974152
Effects of Nicotine Salt Aerosol on Cigarette Smokers
A study testing Subox Mini C with Avail 18 mg nicotine salt (protonated), Subox Mini C with Avail 18 mg nicotine (unprotonated) and Own brand cigarette in people with Electronic Cigarette Use, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- Subox Mini C with Avail 18 mg nicotine salt (protonated), Subox Mini C with Avail 18 mg nicotine (unprotonated) and Own brand cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be:
- healthy (determined by self-report)
- between 21-55 years old
- wiling to provide informed consent
- able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol
- cigarette smokers
Who cannot join
- Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening
- Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23510
About this study
This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.
Read the detailed description
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine "salt" (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.
- Conditions
- Electronic Cigarette Use
- Being tested
- Subox Mini C with Avail 18 mg nicotine salt (protonated), Subox Mini C with Avail 18 mg nicotine (unprotonated), Own brand cigarette
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subox Mini C with Avail 18 mg nicotine salt (protonated)Other
Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
Subox Mini C with Avail 18 mg nicotine (unprotonated)Other
Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
Own brand cigaretteOther
Participants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
| Study group | Role | What they receive |
|---|---|---|
| Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Receives: Other: Subox Mini C with Avail 18 mg nicotine salt (protonated); Other: Subox Mini C with Avail 18 mg nicotine (unprotonated); Other: Own brand cigarette |
| ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Receives: Other: Subox Mini C with Avail 18 mg nicotine salt (protonated); Other: Subox Mini C with Avail 18 mg nicotine (unprotonated); Other: Own brand cigarette |
| ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Receives: Other: Subox Mini C with Avail 18 mg nicotine salt (protonated); Other: Subox Mini C with Avail 18 mg nicotine (unprotonated); Other: Own brand cigarette |
| ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Receives: Other: Subox Mini C with Avail 18 mg nicotine salt (protonated); Other: Subox Mini C with Avail 18 mg nicotine (unprotonated); Other: Own brand cigarette |
| Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Receives: Other: Subox Mini C with Avail 18 mg nicotine salt (protonated); Other: Subox Mini C with Avail 18 mg nicotine (unprotonated); Other: Own brand cigarette |
| ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Receives: Other: Subox Mini C with Avail 18 mg nicotine salt (protonated); Other: Subox Mini C with Avail 18 mg nicotine (unprotonated); Other: Own brand cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Nicotine
Change in plasma nicotine level
Measured: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start10 Jun 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: COVID concerns, funding delays led to cancellation of project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Paul T. Harrell, Eastern Virginia Medical School
- Investigators
- Paul T Harrell, Ph.D., Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974152
- Sponsor's protocol ID
- 19-01-FB-0009
- Other IDs
- U54DA036105, FP00006477_SA007
- Status last verified
- Feb 2024
- First submitted
- 31 May 2019
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine Salt Aerosol on Cigarette Smokers
- ClinicalTrials.gov ID
- NCT03974152
- Acronym / sponsor ID
- 19-01-FB-0009
- Conditions
- Electronic Cigarette Use
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID concerns, funding delays led to cancellation of project
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 2 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.
Detailed description
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine "salt" (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine | Experimental | Other: Subox Mini C with Avail 18 mg nicotine salt (protonated), Other: Subox Mini C with Avail 18 mg nicotine (unprotonated), Other: Own brand cigaretteIn each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
| ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette | Experimental | Other: Subox Mini C with Avail 18 mg nicotine salt (protonated), Other: Subox Mini C with Avail 18 mg nicotine (unprotonated), Other: Own brand cigaretteIn each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
| ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine | Experimental | Other: Subox Mini C with Avail 18 mg nicotine salt (protonated), Other: Subox Mini C with Avail 18 mg nicotine (unprotonated), Other: Own brand cigaretteIn each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
| ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette | Experimental | Other: Subox Mini C with Avail 18 mg nicotine salt (protonated), Other: Subox Mini C with Avail 18 mg nicotine (unprotonated), Other: Own brand cigaretteIn each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
| Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine | Experimental | Other: Subox Mini C with Avail 18 mg nicotine salt (protonated), Other: Subox Mini C with Avail 18 mg nicotine (unprotonated), Other: Own brand cigaretteIn each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
| ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine | Experimental | Other: Subox Mini C with Avail 18 mg nicotine salt (protonated), Other: Subox Mini C with Avail 18 mg nicotine (unprotonated), Other: Own brand cigaretteIn each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy (determined by self-report)
- between 21-55 years old
- wiling to provide informed consent
- able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol
- cigarette smokers
Key exclusion criteria (2 listed)
- Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening
- Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
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 |
|---|---|---|
| Subox Mini C with Avail 18 mg nicotine salt (protonated)Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. | Other | ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette, ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine, ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette, ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine, Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine, Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine |
| Subox Mini C with Avail 18 mg nicotine (unprotonated)Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. | Other | ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette, ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine, ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette, ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine, Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine, Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine |
| Own brand cigaretteParticipants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. | Other | ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette, ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine, ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette, ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine, Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine, Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine |
Primary outcome
Plasma Nicotine
Time frame: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Change in plasma nicotine level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Paul T Harrell, Ph.D. principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subox Mini C with Avail 18 mg nicotine salt (protonated), Subox Mini C with Avail 18 mg nicotine (unprotonated) and Own brand cigarette in people with Electronic Cigarette Use, run by Eastern Virginia Medical School 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Mar 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?
Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Nicotine (time frame: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.). 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 26 Mar 2024.