Nicotine DependenceNCT03072628
E-cigarettes, Nicotine Inhaler, and Blood Vessel Function
A study testing e-cig with nicotine, e-cig without nicotine and nicotine inhaler in people with Nicotine Dependence, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- e-cig with nicotine, e-cig without nicotine and nicotine inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2017to 1 Dec 2022
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- Cardiac disease
- Respiratory disease
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity
Read the detailed description
Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.
- Conditions
- Nicotine Dependence
- Being tested
- e-cig with nicotine, e-cig without nicotine, nicotine inhaler, sham control
- Keywords
- nicotine, sympathetic nerve activity, oxidative stress
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-cig with nicotineOther
use an e-cig with nicotine for 30 minutes
e-cig without nicotineOther
use an e-cig without nicotine for 30 minutes
nicotine inhalerOther
use a nicotine inhaler for 30 minutes
sham controlOther
use an empty e-cigarette for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Nicotine: use e-cig with nicotine | Experimental | One time exposure to e-cig with nicotine Receives: Other: e-cig with nicotine |
| no nicotine: use e-cig without nicotine | Experimental | One time exposure to e-cig without nicotine Receives: Other: e-cig without nicotine |
| Nicotine inhaler: use a nictoine inhaler | Experimental | One time exposure to nicotine inhaler Receives: Other: nicotine inhaler |
| Sham control | Sham comparator | Use an empty e-cigarette Receives: Other: sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated dilatation (FMD)
FMD is a measure of endothelial function
Measured: 10 minutes after exposure
Heart rate variability (HRV)
HRV is a measure of cardiac sympathetic tone
Measured: 10 minutes after exposure
Secondary outcomes (1)
Paraoxonase (PON)
PON is a measure of oxidative stress
Measured: ~30 minutes after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start11 Jan 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly R Middlekauff, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072628
- Sponsor's protocol ID
- 14-000743-AM-00008
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2017
- Last updated
- 4 Oct 2023
- Results posted
- No
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
- ClinicalTrials.gov ID
- NCT03072628
- Acronym / sponsor ID
- 14-000743-AM-00008
- Conditions
- Nicotine Dependence
- Keywords
- nicotine, sympathetic nerve activity, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Mar 2017 (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.
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity
Detailed description
Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine: use e-cig with nicotine | Experimental | Other: e-cig with nicotineOne time exposure to e-cig with nicotine |
| no nicotine: use e-cig without nicotine | Experimental | Other: e-cig without nicotineOne time exposure to e-cig without nicotine |
| Nicotine inhaler: use a nictoine inhaler | Experimental | Other: nicotine inhalerOne time exposure to nicotine inhaler |
| Sham control | Sham comparator | Other: sham controlUse an empty e-cigarette |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (3 listed)
- Cardiac disease
- Respiratory disease
- Diabetes mellitus
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 |
|---|---|---|
| e-cig with nicotineuse an e-cig with nicotine for 30 minutes | Other | Nicotine: use e-cig with nicotine |
| e-cig without nicotineuse an e-cig without nicotine for 30 minutes | Other | no nicotine: use e-cig without nicotine |
| nicotine inhaleruse a nicotine inhaler for 30 minutes | Other | Nicotine inhaler: use a nictoine inhaler |
| sham controluse an empty e-cigarette for 30 minutes | Other | Sham control |
Primary outcome
Flow Mediated dilatation (FMD)
Time frame: 10 minutes after exposure
FMD is a measure of endothelial function
Heart rate variability (HRV)
Time frame: 10 minutes after exposure
HRV is a measure of cardiac sympathetic tone
1 secondary outcome
Paraoxonase (PON)
Time frame: ~30 minutes after exposure
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 4 Oct 2023.
- 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.
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 study testing e-cig with nicotine, e-cig without nicotine and nicotine inhaler in people with Nicotine Dependence, run by University of California, Los Angeles 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 1 inclusion and 3 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 4 Oct 2023. 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.
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?
Flow Mediated dilatation (FMD) (time frame: 10 minutes after exposure). 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 4 Oct 2023.