Endothelial DysfunctionNCT03690427
The Cardiovascular Effects of Electronic Hookah Vaping
A study testing Traditional hookah smoking and Electronic hookah vaping in people with Endothelial Dysfunction and Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Hookah (water-pipe) tobacco smoking has quickly grown to become a major global tobacco epidemic among youth; with electronic (e-) hookahs more recently increasing in popularity especially among young female adults, who endorse marketing claims that these products are a safer alternative to traditional hookah, but… Read more about this study
- Who is it for?
- Ages 21 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Inflammation, Oxidative Stress
- What is being tested?
- Traditional hookah smoking and Electronic hookah vaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2018to 27 Sep 2021
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-39 years old hookah smokers: smoked hookah >12x in last 12 months
- no history of illicit drugs or marijuana
- no evidence of cardiopulmonary disease by history/ physical
- no diabetes: fasting blood glucose <100 mg/dl
- BP<140/90mmHg
- resting HR<100 bpm
- BMI<30kg•m2
- no prescription medication
Who cannot join
- exhaled CO>10 ppm (smoking non-abstinence)
- positive pregnancy test
- psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095-8361
About this study
Official title: Investigating the Cardiovascular Toxicity of Exposure to Electronic Hookah Smoking
Hookah (water-pipe) tobacco smoking has quickly grown to become a major global tobacco epidemic among youth; with electronic (e-) hookahs more recently increasing in popularity especially among young female adults, who endorse marketing claims that these products are a safer alternative to traditional hookah, but scientific evidence is lacking. The study aims to elucidate the comparative effects of traditional hookah smoking vs. e-hookah vaping on human vascular and endothelial function; and examine the role of inflammation and oxidative stress, as likely mechanisms in hookah-related cardiovascular disease pathogenesis.
Read the detailed description
Hookah (water-pipe) tobacco smoking is rapidly increasing in popularity worldwide. Contributing to this popularity is the unsubstantiated belief that traditional charcoal-heated hookah smoke is detoxified as it passes through the water-filled basin. More recently, electronic (e-) hookahs-containing flavored e-liquid that is heated electrically but inhaled through traditional water-pipes-are increasing in popularity in the United States among young female adults, who endorse marketing claims that these products are even safer than traditional charcoal-heated hookah products. The objective of this project is to investigate the comparative effects of traditional charcoal-heated hookah smoking versus e-hookah vaping on endothelial and vascular function and their mechanistic role in the development of cardiovascular disease. The investigators will test the hypothesis that: 1) in the absence of burning charcoal briquettes and virtually any carbon monoxide (CO) exposure, e-hookah vaping acutely impairs endothelial function and evokes acute central arterial stiffness, opposite from the endothelial function augmentation observed after traditional charcoal-heated hookah smoking, which is likely mediated by the large CO boost emitted from burning charcoal briquettes used to heat the flavored hookah tobacco; and 2) the processes of oxidative stress and inflammation play a pivotal mechanistic role underlying these vascular changes. Accordingly, in a cross-over study comparing traditional hookah smoking to e-hookah vaping, the investigators will assess endothelial function measured by brachial artery flow-mediated dilation and aortic stiffness by pulse wave velocity and augmentation index in 18 young healthy hookah smokers 21-39 years old, before and after ad lib 30-minute smoking/ vaping exposure sessions. To test for oxidative stress mediation, the investigators will determine if any acute impairment in endothelial function after e-hookah can be prevented by intravenous Vitamin C infusion, a potent anti-oxidant. Inflammatory and oxidant biomarkers, as well as smoking exposure biomarkers will be collected before and after the exposure sessions. The results of this proposal: (a) stand to fill in gaps in our mechanistic understanding of the comparative effect of traditional vs. e-hookah bowl on vascular and endothelial function; and (b) help inform policy decisions by the FDA about regulation of hookah products.
- Conditions
- Endothelial Dysfunction, Inflammation, Oxidative Stress
- Being tested
- Traditional hookah smoking, Electronic hookah vaping
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional hookah smokingOther
Also called Combustible hookah smoking
Charcoal-heated hookah smoking
Electronic hookah vapingOther
Electronic hookah bowl inhalation
| Study group | Role | What they receive |
|---|---|---|
| Traditional Charcoal-Heated Hookah followed by Electronic Hookah | Experimental | Participants were invited to smoke a 30-minute traditional charcoal-heated hookah-smoking session, followed by a 30-minute electronic hookah vaping session.
To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days. Receives: Other: Traditional hookah smoking; Other: Electronic hookah vaping |
| Electronic followed by Traditional Charcoal-Heated Hookah | Experimental | Participants were invited to vape a 30-minute electronic hookah session, followed by a 30-minute traditional charcoal-heated hookah smoking session.
To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days. Receives: Other: Traditional hookah smoking; Other: Electronic hookah vaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-Mediated Dilation (FMD)
Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function. Baseline diameter and velocity were recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Carotid-Femoral Pulse Wave Velocity (Cf-PWV)
Using applanation tonometry, cf-PWV was used to measure central arterial stiffness.
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
HDL Oxidant Index (HOI)
Capacity was determined as the ability of HDL to inhibit LDL-induced oxidation of dihydrodichlorofluorescein into the fluorescent dichlorofluorescein. Capacity was expressed as an HDL oxidative index, determined by the ratio of dichlorofluorescein fluorescence in the presence and absence of HDL. An index of < 1.0 denotes protective antioxidant HDL, whereas an index of > 1.0 indicates pro-oxidant HDL.
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Paraoxonase-1 (PON-1) Activity
PON-1 activity was determined by the ability of PON-1, associated with HDL, to hydrolyze paraoxon substrate. The hydrolysis of paraoxon (diethyl-p-nitrophenyl phosphate) to p-nitrophenol by PON-1 was determined by incubating 5 mL of plasma with 1.0 mM paraoxon in 100 mM tris-HCl buffer (pH, 8.5).
Unit of Measure: expressed as micromoles of p-nitrophenol formed per minute for every 1 mL plasma.
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Arylesterase Activity
Arylesterase activity (lipid peroxidation biomarker) was determined by the rate of hydrolysis of phenyl acetate to phenol. Briefly, 4 mL plasma was incubated with 3.5 mM phenyl acetate in 9 mM Tris-HCl buffer (pH, 8.0) containing 0.9 mM CaCl2 at RT. The kinetics of phenol formation were determined by recording the absorbance at 270 nm every 15 s for 2 min.
Unit of Measure: nanomoles of product formed per minute per milliliter of plasma.
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions.
High-sensitivity C-reactive Protein (Hs-CRP) Levels
Plasma hs-CRP (inflammatory biomarker)
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Tumor Necrosis Factor-α (TNFα) Concentrations
Plasma TNFα (inflammatory biomarker)
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Secondary outcomes (7)
Flow-Mediated Dilation (FMD)
Using ultrasound, FMD of the brachial artery, induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function after intravenous infusion of antioxidant ascorbic acid. Infusion of antioxidant ascorbic acid was done before the e-hookah vaping session.
Measured: Effect of FMD with e-hookah vaping examined after pretreatment of intravenous infusion of antioxidant ascorbic acid (administered over 60 minutes at 0.5 mL min-1)
Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)
As a control test for the assessment of endothelium-dependent vasodilator function, using ultrasound the brachial artery, endothelium-independent dilatation was assessed by administering sublingual nitroglycerin. This measure was assessed 10 minutes after FMD testing. Ultrasound images were recorded continuously for a total of 10 minutes
Measured: Pre- and post- sublingual administration of nitroglycerin (0.15 mg), which was administrated before and after e-hookah vaping.
Augmentation Index (AI)
AI was used to measure central stiffness. It was calculated as the ratio of augmentation pressure (difference between the second and first systolic peaks of the aortic pressure waveform) and pulse pressure expressed as a percentage.
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Interleukin 6 (IL-6) Levels
Plasma IL-6 (inflammatory biomarker).
Measured: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).
Interleukin 10 (IL-10) Levels
Serum IL-10 (anti-inflammatory biomarker)
Measured: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).
Nicotine Levels
Plasma nicotine levels (smoking or vaping exposure biomarker)
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Carbon Monoxide (CO) Levels
Exhaled CO levels (smoking or vaping exposure biomarker)
Measured: Pre- and post- the 30-minute smoking or vaping exposure sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start11 Dec 2018
- Primary completion31 Aug 2021
- Study completion27 Sep 2021
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Charcoal-heated hookah smoking vs. electronic hookah vaping
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mary Rezk-Hanna, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690427
- Sponsor's protocol ID
- 1R21HL145002-01
- Other IDs
- 1R21HL145002-01
- Status last verified
- Jul 2023
- First submitted
- 26 Sep 2018
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rezk-Hanna M, Gupta R, Nettle CO, Dobrin D, Cheng CW, Means A, Brecht ML, Tashkin DP, Araujo JA. Differential Effects of Electronic Hookah Vaping and Traditional Combustible Hookah Smoking on Oxidation, Inflammation, and Arterial Stiffness. Chest. 2022 Jan;161(1):208-218. doi: 10.1016/j.chest.2021.07.027. Epub 2021 Jul 21.
PubMed 34298007Rezk-Hanna M, Seals DR, Rossman MJ, Gupta R, Nettle CO, Means A, Dobrin D, Cheng CW, Brecht ML, Mosenifar Z, Araujo JA, Benowitz NL. Ascorbic Acid Prevents Vascular Endothelial Dysfunction Induced by Electronic Hookah (Waterpipe) Vaping. J Am Heart Assoc. 2021 Feb;10(5):e019271. doi: 10.1161/JAHA.120.019271. Epub 2021 Feb 20.
PubMed 33615833
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Cardiovascular Toxicity of Exposure to Electronic Hookah Smoking
- ClinicalTrials.gov ID
- NCT03690427
- Acronym / sponsor ID
- 1R21HL145002-01
- Conditions
- Endothelial Dysfunction, Inflammation, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hookah (water-pipe) tobacco smoking has quickly grown to become a major global tobacco epidemic among youth; with electronic (e-) hookahs more recently increasing in popularity especially among young female adults, who endorse marketing claims that these products are a safer alternative to traditional hookah, but scientific evidence is lacking. The study aims to elucidate the comparative effects of traditional hookah smoking vs. e-hookah vaping on human vascular and endothelial function; and examine the role of inflammation and oxidative stress, as likely mechanisms in hookah-related cardiovascular disease pathogenesis.
Detailed description
Hookah (water-pipe) tobacco smoking is rapidly increasing in popularity worldwide. Contributing to this popularity is the unsubstantiated belief that traditional charcoal-heated hookah smoke is detoxified as it passes through the water-filled basin. More recently, electronic (e-) hookahs-containing flavored e-liquid that is heated electrically but inhaled through traditional water-pipes-are increasing in popularity in the United States among young female adults, who endorse marketing claims that these products are even safer than traditional charcoal-heated hookah products. The objective of this project is to investigate the comparative effects of traditional charcoal-heated hookah smoking versus e-hookah vaping on endothelial and vascular function and their mechanistic role in the development of cardiovascular disease. The investigators will test the hypothesis that: 1) in the absence of burning charcoal briquettes and virtually any carbon monoxide (CO) exposure, e-hookah vaping acutely impairs endothelial function and evokes acute central arterial stiffness, opposite from the endothelial function augmentation observed after traditional charcoal-heated hookah smoking, which is likely mediated by the large CO boost emitted from burning charcoal briquettes used to heat the flavored hookah tobacco; and 2) the processes of oxidative stress and inflammation play a pivotal mechanistic role underlying these vascular changes. Accordingly, in a cross-over study comparing traditional hookah smoking to e-hookah vaping, the investigators will assess endothelial function measured by brachial artery flow-mediated dilation and aortic stiffness by pulse wave velocity and augmentation index in 18 young healthy hookah smokers 21-39 years old, before and after ad lib 30-minute smoking/ vaping exposure sessions. To test for oxidative stress mediation, the investigators will determine if any acute impairment in endothelial function after e-hookah can be prevented by intravenous Vitamin C infusion, a potent anti-oxidant. Inflammatory and oxidant biomarkers, as well as smoking exposure biomarkers will be collected before and after the exposure sessions. The results of this proposal: (a) stand to fill in gaps in our mechanistic understanding of the comparative effect of traditional vs. e-hookah bowl on vascular and endothelial function; and (b) help inform policy decisions by the FDA about regulation of hookah products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Charcoal-heated hookah smoking vs. electronic hookah vaping
| Arm | Type | Receives |
|---|---|---|
| Traditional Charcoal-Heated Hookah followed by Electronic Hookah | Experimental | Other: Traditional hookah smoking, Other: Electronic hookah vapingParticipants were invited to smoke a 30-minute traditional charcoal-heated hookah-smoking session, followed by a 30-minute electronic hookah vaping session. To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days. |
| Electronic followed by Traditional Charcoal-Heated Hookah | Experimental | Other: Traditional hookah smoking, Other: Electronic hookah vapingParticipants were invited to vape a 30-minute electronic hookah session, followed by a 30-minute traditional charcoal-heated hookah smoking session. To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 21-39 years old hookah smokers: smoked hookah >12x in last 12 months
- no history of illicit drugs or marijuana
- no evidence of cardiopulmonary disease by history/ physical
- no diabetes: fasting blood glucose <100 mg/dl
- BP<140/90mmHg
Key exclusion criteria (3 listed)
- exhaled CO>10 ppm (smoking non-abstinence)
- positive pregnancy test
- psychiatric illness
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 |
|---|---|---|
| Traditional hookah smokingAlso: Combustible hookah smokingCharcoal-heated hookah smoking | Other | Electronic followed by Traditional Charcoal-Heated Hookah, Traditional Charcoal-Heated Hookah followed by Electronic Hookah |
| Electronic hookah vapingElectronic hookah bowl inhalation | Other | Electronic followed by Traditional Charcoal-Heated Hookah, Traditional Charcoal-Heated Hookah followed by Electronic Hookah |
Primary outcome
Flow-Mediated Dilation (FMD)
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function. Baseline diameter and velocity were recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.
Carotid-Femoral Pulse Wave Velocity (Cf-PWV)
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Using applanation tonometry, cf-PWV was used to measure central arterial stiffness.
HDL Oxidant Index (HOI)
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Capacity was determined as the ability of HDL to inhibit LDL-induced oxidation of dihydrodichlorofluorescein into the fluorescent dichlorofluorescein. Capacity was expressed as an HDL oxidative index, determined by the ratio of dichlorofluorescein fluorescence in the presence and absence of HDL. An index of < 1.0 denotes protective antioxidant HDL, whereas an index of > 1.0 indicates pro-oxidant HDL.
Paraoxonase-1 (PON-1) Activity
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
PON-1 activity was determined by the ability of PON-1, associated with HDL, to hydrolyze paraoxon substrate. The hydrolysis of paraoxon (diethyl-p-nitrophenyl phosphate) to p-nitrophenol by PON-1 was determined by incubating 5 mL of plasma with 1.0 mM paraoxon in 100 mM tris-HCl buffer (pH, 8.5). Unit of Measure: expressed as micromoles of p-nitrophenol formed per minute for every 1 mL plasma.
Arylesterase Activity
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions.
Arylesterase activity (lipid peroxidation biomarker) was determined by the rate of hydrolysis of phenyl acetate to phenol. Briefly, 4 mL plasma was incubated with 3.5 mM phenyl acetate in 9 mM Tris-HCl buffer (pH, 8.0) containing 0.9 mM CaCl2 at RT. The kinetics of phenol formation were determined by recording the absorbance at 270 nm every 15 s for 2 min. Unit of Measure: nanomoles of product formed per minute per milliliter of plasma.
High-sensitivity C-reactive Protein (Hs-CRP) Levels
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Plasma hs-CRP (inflammatory biomarker)
Tumor Necrosis Factor-α (TNFα) Concentrations
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Plasma TNFα (inflammatory biomarker)
7 secondary outcomes
Flow-Mediated Dilation (FMD)
Time frame: Effect of FMD with e-hookah vaping examined after pretreatment of intravenous infusion of antioxidant ascorbic acid (administered over 60 minutes at 0.5 mL min-1)
Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)
Time frame: Pre- and post- sublingual administration of nitroglycerin (0.15 mg), which was administrated before and after e-hookah vaping.
Augmentation Index (AI)
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Interleukin 6 (IL-6) Levels
Time frame: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).
Interleukin 10 (IL-10) Levels
Time frame: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).
Nicotine Levels
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Carbon Monoxide (CO) Levels
Time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34298007Rezk-Hanna M, Gupta R, Nettle CO, Dobrin D, Cheng CW, Means A, Brecht ML, Tashkin DP, Araujo JA. Differential Effects of Electronic Hookah Vaping and Traditional Combustible Hookah Smoking on Oxidation, Inflammation, and Arterial Stiffness. Chest. 2022 Jan;161(1):208-218. doi: 10.1016/j.chest.2021.07.027. Epub 2021 Jul 21.
- Derived from this study: PubMed 33615833Rezk-Hanna M, Seals DR, Rossman MJ, Gupta R, Nettle CO, Means A, Dobrin D, Cheng CW, Brecht ML, Mosenifar Z, Araujo JA, Benowitz NL. Ascorbic Acid Prevents Vascular Endothelial Dysfunction Induced by Electronic Hookah (Waterpipe) Vaping. J Am Heart Assoc. 2021 Feb;10(5):e019271. doi: 10.1161/JAHA.120.019271. Epub 2021 Feb 20.
- Individual participant dataSharing planned: Undecided
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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 Traditional hookah smoking and Electronic hookah vaping in people with Endothelial Dysfunction and Inflammation, 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 8 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 16 Aug 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. 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 16 Aug 2023). 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?
Flow-Mediated Dilation (FMD) (time frame: Pre- and post- the 30-minute smoking or vaping exposure sessions). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690427, which also lists 2 linked publications.
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 16 Aug 2023.