E Cigarette UseNCT04568395
Acute Effects of TCIG vs ECIG in PLWH
A study testing TCIG and ECIG in people with E Cigarette Use and Vaping, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- E Cigarette Use, Vaping, Smoking
- What is being tested?
- TCIG and ECIG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 8 May 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic (> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 >500
Who cannot join
- Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis >2 alcoholic drinks per day Obesity (>30 kg/m2) Recent (<3 months) infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA
Los Angeles, California, 890095
UCaliforniaLA
Los Angeles, California, 90095
About this study
Official title: Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.
Read the detailed description
On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.
- Conditions
- E Cigarette Use, Vaping, Smoking, Tobacco Smoking, Nicotine Use Disorder, Qt Interval, Variation in
- Being tested
- TCIG, ECIG, sham control
- Medical subject headings
- Vaping, Smoking, Tobacco Smoking, Tobacco Use Disorder, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCIGOther
Use a TCIG
ECIGOther
Use an ECIG
sham controlOther
Use a sham control (empty ECIG)
| Study group | Role | What they receive |
|---|---|---|
| PLWH smoker | Experimental | PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control Receives: Other: TCIG; Other: ECIG; Other: sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tpe
interval indicative of ventricular repolarization measured on ECG
Measured: Change in Tpe 5 minutes after cigarette use
Tpe/QT
interval indicative of ventricular repolarization measured on ECG
Measured: Change in Tpe/QT after cigarette use
Tpe/QTc
interval indicative of ventricular repolarization measured on ECG
Measured: Change in Tpe/QTc after cigarette use
Total Cellular Reactive Oxygen Stress
total cellular oxidative stress measured by flow cytometry
Measured: within 4 hours of cigarette use
Secondary outcomes (2)
QT
interval indicative of ventricular repolarization measured on ECG
Measured: Change in QT after cigarette use
QTc
interval indicative of ventricular repolarization measured on ECG
Measured: Change in QTc after cigarette use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Oct 2020
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E Cigarette UseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Crossover with 1 week washout
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Principal investigator, Holly R Middlekauff, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568395
- Sponsor's protocol ID
- 20-001179
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2020
- 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
- Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV
- ClinicalTrials.gov ID
- NCT04568395
- Acronym / sponsor ID
- 20-001179
- Conditions
- E Cigarette Use, Vaping, Smoking, Tobacco Smoking, Nicotine Use Disorder, Qt Interval, Variation in
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 29 Sep 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.
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.
Detailed description
On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Crossover with 1 week washout
| Arm | Type | Receives |
|---|---|---|
| PLWH smoker | Experimental | Other: TCIG, Other: ECIG, Other: sham controlPLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Chronic (> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 >500
Key exclusion criteria (1 listed)
- Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis >2 alcoholic drinks per day Obesity (>30 kg/m2) Recent (<3 months) infection
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 |
|---|---|---|
| TCIGUse a TCIG | Other | PLWH smoker |
| ECIGUse an ECIG | Other | PLWH smoker |
| sham controlUse a sham control (empty ECIG) | Other | PLWH smoker |
Primary outcome
Tpe
Time frame: Change in Tpe 5 minutes after cigarette use
interval indicative of ventricular repolarization measured on ECG
Tpe/QT
Time frame: Change in Tpe/QT after cigarette use
interval indicative of ventricular repolarization measured on ECG
Tpe/QTc
Time frame: Change in Tpe/QTc after cigarette use
interval indicative of ventricular repolarization measured on ECG
Total Cellular Reactive Oxygen Stress
Time frame: within 4 hours of cigarette use
total cellular oxidative stress measured by flow cytometry
2 secondary outcomes
QT
Time frame: Change in QT after cigarette use
QTc
Time frame: Change in QTc after cigarette use
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCIG and ECIG in people with E Cigarette Use and Vaping, run by University of California, Los Angeles at 2 sites 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 1 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 2 sites 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?
Tpe (time frame: Change in Tpe 5 minutes after cigarette use). The study lists 4 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.