Electronic Cigarette UseEarly Phase 1NCT04613609
Vaporized Nicotine and Autonomic Control
A Early Phase 1 study testing Electronic Cigarette containing nicotine and Electronic Cigarette without nicotine in people with Electronic Cigarette Use, run by Michigan Technological University at 1 site in United States.
Trial summary
E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- Electronic Cigarette containing nicotine and Electronic Cigarette without nicotine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 1 Jul 2019
- Phase
- Early Phase 1
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Individuals with a history of hyperthyroidism
- Women currently taking oral contraceptives, are pregnant or breast-feeding, or trying to become pregnant
- Individuals currently taking prescription drugs.
- Individuals with respiratory illnesses (e.g., asthma, chronic obstructive pulmonary disease, reactive airway disease, etc.)
- Individuals with hypertension (systolic >130 and/or diastolic > 80).
- Individuals with a history of tobacco or vaporized nicotine use.
- Individuals who have been diagnosed with diabetes
- Individuals who are under the age of 18 or over the age of 40
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Technological University
Houghton, Michigan, 49930
About this study
E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been reported: our purpose was to clarify this issue. Using a randomized crossover design, participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo e-cigarette (0 mg/ml).
- Conditions
- Electronic Cigarette Use
- Being tested
- Electronic Cigarette containing nicotine, Electronic Cigarette without nicotine
- Keywords
- E-cigarette, Autonomic Control, Muscle Sympathetic Nerve Activity
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Cigarette containing nicotineDevice
Also called JUUL (brand name)
Non-smokers used an electronic cigarette containing nicotine
Electronic Cigarette without nicotineDevice
Also called Smok (brand name)
Non-smokers used an electronic cigarette without nicotine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | E-cigarette containing no nicotine. Receives: Device: Electronic Cigarette without nicotine |
| Nicotine | Active comparator | E-cigarette containing nicotine Receives: Device: Electronic Cigarette containing nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (measured from the finger)
Effects of electronic cigarettes on both systolic and diastolic arterial pressure.
Measured: Experiments were separated by one month. Beat-to-beat arterial pressure was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.
Muscle sympathetic nerve activity (measured with the microneurography technique)
Effects of electronic cigarettes on muscle sympathetic nerve activity (MSNA)
Measured: Experiments were separated by one month. MSNA was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Apr 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated Measures
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613609
- Sponsor's protocol ID
- M1747
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaporized Nicotine and Autonomic Control
- ClinicalTrials.gov ID
- NCT04613609
- Acronym / sponsor ID
- M1747
- Conditions
- Electronic Cigarette Use
- Keywords
- E-cigarette, Autonomic Control, Muscle Sympathetic Nerve Activity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Michigan Technological UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 Nov 2020 (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.
E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been reported: our purpose was to clarify this issue. Using a randomized crossover design, participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo e-cigarette (0 mg/ml).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Repeated Measures
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: Electronic Cigarette without nicotineE-cigarette containing no nicotine. |
| Nicotine | Active comparator | Device: Electronic Cigarette containing nicotineE-cigarette containing nicotine |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Individuals with a history of hyperthyroidism
- Women currently taking oral contraceptives, are pregnant or breast-feeding, or trying to become pregnant
- Individuals currently taking prescription drugs.
- Individuals with respiratory illnesses (e.g., asthma, chronic obstructive pulmonary disease, reactive airway disease, etc.)
- Individuals with hypertension (systolic >130 and/or diastolic > 80).
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 |
|---|---|---|
| Electronic Cigarette containing nicotineAlso: JUUL (brand name)Non-smokers used an electronic cigarette containing nicotine | Device | Nicotine |
| Electronic Cigarette without nicotineAlso: Smok (brand name)Non-smokers used an electronic cigarette without nicotine | Device | Placebo |
Primary outcome
Blood pressure (measured from the finger)
Time frame: Experiments were separated by one month. Beat-to-beat arterial pressure was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.
Effects of electronic cigarettes on both systolic and diastolic arterial pressure.
Muscle sympathetic nerve activity (measured with the microneurography technique)
Time frame: Experiments were separated by one month. MSNA was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.
Effects of electronic cigarettes on muscle sympathetic nerve activity (MSNA)
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 3 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Electronic Cigarette containing nicotine and Electronic Cigarette without nicotine in people with Electronic Cigarette Use, run by Michigan Technological 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 0 inclusion and 8 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 3 Nov 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood pressure (measured from the finger) (time frame: Experiments were separated by one month. Beat-to-beat arterial pressure was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.). The study lists 2 primary outcomes in all. 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 3 Nov 2020.