Cigarette Smoking ToxicityPhase 1ACENCT03010995
The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
A Phase 1 study testing Prazosin in people with Cigarette Smoking Toxicity and Nicotine, run by University of Louisville at 1 site in United States.
Trial summary
The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking Toxicity, Nicotine, Acute Cardiovascular Disease
- What is being tested?
- Prazosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2018to 24 Jul 2018
- Phase
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant will be currently healthy individuals, between 18 and 40 years of age.
- E-Cigarette users using E-Cigarette for at least 1 month and smoke ≤ 1 tobacco cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their lifetime and are not active nicotine/tobacco or related product users
- Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study.
- Do not meet any of the Exclusion criteria.
Who cannot join
- Unwilling or unable to provide informed consent.
- Participant that have: Diabetes, Hypertension HIV, hepatitis, liver disease (including fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ transplant, renal replacement therapy, kidney disease or insufficiency, dialysis, active cancer of any type, and untreated thyroid disease, major injury or trauma.
- Body weight less than 100 pounds or BMI >40.
- Participants that are taking the following medications: estrogen, testosterone, anti TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid, rifampicin certain biologics, or Procrit
- Participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device
- Pregnant or lactating women.
- Prisoners and other vulnerable populations.
- Anyone that PI thinks is unsafe to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment.
Read the detailed description
We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1 month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10 non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active nicotine/tobacco or related product user) for a one study visit.The participants will be asked to abstain from all tobacco/nicotine and related product use for 12 hours before each visit.
Measurements will be taken at each study visit before and after E-cigarette use, each day with different nicotine dose, to look at both the individuals' exposure to nicotine and also the effects on the cardiovascular system. These measurements will include blood and urine samples as well as non-invasive cardiovascular measurements.
- Being tested
- Prazosin
- Keywords
- electronic cigarette, endothelial function
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrazosinDrug
Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes
| Study group | Role | What they receive |
|---|---|---|
| 18 mg nicotine | Active comparator | E-cigarette with 18 mg nicotine Receives: Drug: Prazosin |
| 9 mg nicotine | Active comparator | E-cigarette with 9 mg nicotine Receives: Drug: Prazosin |
| 0 mg nicotine | Placebo comparator | E-cigarette with 0 mg nicotine Receives: Drug: Prazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Flow mediated dilatation
Measured: Change between baseline and post exposure 20-30 mins
Secondary outcomes (4)
Heart rate
Heart rate monitor
Measured: Change between baseline and post exposure 5,10, 30, 60, 120 mins
Blood pressure
Blood pressure monitor
Measured: Change between baseline and post exposure 5,10, 30, 60, 120 mins
Heart Rate Variability
SphygmoCor HRV system SCOR-Hx
Measured: Change between baseline and post exposure 20 mins
Nicotine levels in plasma
Detect plasma nicotine levels
Measured: Change between Baseline and over 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start13 Mar 2018
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
Why it stopped: Study discontinued due to lack of study funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking ToxicityStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Affan B. Irfan, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010995
- Sponsor's protocol ID
- 16.1079
- Acronym
- ACE
- Status last verified
- Jul 2018
- First submitted
- 9 Dec 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
- ClinicalTrials.gov ID
- NCT03010995
- Acronym / sponsor ID
- ACE / 16.1079
- Keywords
- electronic cigarette, endothelial function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study discontinued due to lack of study funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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.
The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment.
Detailed description
We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1 month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10 non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active nicotine/tobacco or related product user) for a one study visit.The participants will be asked to abstain from all tobacco/nicotine and related product use for 12 hours before each visit.
Measurements will be taken at each study visit before and after E-cigarette use, each day with different nicotine dose, to look at both the individuals' exposure to nicotine and also the effects on the cardiovascular system. These measurements will include blood and urine samples as well as non-invasive cardiovascular measurements.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18 mg nicotine | Active comparator | Drug: PrazosinE-cigarette with 18 mg nicotine |
| 9 mg nicotine | Active comparator | Drug: PrazosinE-cigarette with 9 mg nicotine |
| 0 mg nicotine | Placebo comparator | Drug: PrazosinE-cigarette with 0 mg nicotine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant will be currently healthy individuals, between 18 and 40 years of age.
- E-Cigarette users using E-Cigarette for at least 1 month and smoke ≤ 1 tobacco cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their lifetime and are not active nicotine/tobacco or related product users
- Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study.
- Do not meet any of the Exclusion criteria.
Key exclusion criteria (8 listed)
- Unwilling or unable to provide informed consent.
- Participant that have: Diabetes, Hypertension HIV, hepatitis, liver disease (including fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ transplant, renal replacement therapy, kidney disease or insufficiency, dialysis, active cancer of any type, and untreated thyroid disease, major injury or trauma.
- Body weight less than 100 pounds or BMI >40.
- Participants that are taking the following medications: estrogen, testosterone, anti TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid, rifampicin certain biologics, or Procrit
- Participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device
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 |
|---|---|---|
| PrazosinPrazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes | Drug | 0 mg nicotine, 18 mg nicotine, 9 mg nicotine |
Primary outcome
Endothelial function
Time frame: Change between baseline and post exposure 20-30 mins
Flow mediated dilatation
4 secondary outcomes
Heart rate
Time frame: Change between baseline and post exposure 5,10, 30, 60, 120 mins
Blood pressure
Time frame: Change between baseline and post exposure 5,10, 30, 60, 120 mins
Heart Rate Variability
Time frame: Change between baseline and post exposure 20 mins
Nicotine levels in plasma
Time frame: Change between Baseline and over 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: No
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 Phase 1 study testing Prazosin in people with Cigarette Smoking Toxicity and Nicotine, run by University of Louisville 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 4 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: withdrawn, as of the sponsor's last update on 26 Jul 2018. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Endothelial function (time frame: Change between baseline and post exposure 20-30 mins). 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 Jul 2018.