Recruiting PHASE1, PHASE2 E-Cig Use

New treatment option for E-Cig Use

Official title Hyperpolarized Xenon-129 MR Imaging of the Lung

ClinicalTrials.gov ID: NCT04662658

What this study is testing

What is Hyperpolarized Xenon -129 MRI?

Hyperpolarized Xenon -129 MRI is an investigational medicine, being studied as a potential treatment for e-cig use.

Also referred to as MRI with xenon-129 gas.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Over the past 10 years, electronic cigarettes (e-cigarettes, EC) have been commercialized as a "less harmful" alternative to traditional cigarettes.1,2 However, e-cigarettes are believed to cause pulmonary epithelial, endothelial and vascular dysfunction, and to cause murine phenotypes similar to those of human COPD. Recently, "spiked" vape juice has been linked to severe lung damage.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Male and female people 21-30 years of age
  • At baseline health with no recent illnesses or medical conditions that would preclude enrollment as assessed by the Principal Investigator
  • Ability to understand a written informed consent form and comply with the requirements of the study.
  • E-cigarette use for more than 6 months preceding the date of enrollment and less than a 5 pack year smoking history (e-cigarette users) OR less than...
  • No diagnosis of any lung disease (pre-bronchodilator FEV1/FVC normal on the day of screening defined by \> 95thCI of NHANES III, ATS/ERS guideline)

You likely can't join if

  • History of any lung disease
  • Control (non-smoking) group: History of illegal drug use by inhalation
  • History of CNS disease including stroke and dementia, end-stage liver disease, coronary artery disease, renal failure
  • Acute infection of any kind in the previous 6 weeks
  • Pregnancy or a possibility of pregnancy
  • Anemia
See the full eligibility criteria
Who can join
  • Male and female people 21-30 years of age
  • At baseline health with no recent illnesses or medical conditions that would preclude enrollment as assessed by the Principal Investigator
  • Ability to understand a written informed consent form and comply with the requirements of the study.
  • E-cigarette use for more than 6 months preceding the date of enrollment and less than a 5 pack year smoking history (e-cigarette users) OR less than a 5 pack year smoking history (non-smoker group).
  • No diagnosis of any lung disease (pre-bronchodilator FEV1/FVC normal on the day of screening defined by \> 95thCI of NHANES III, ATS/ERS guideline)
What rules you out
  • History of any lung disease
  • Control (non-smoking) group: History of illegal drug use by inhalation
  • History of CNS disease including stroke and dementia, end-stage liver disease, coronary artery disease, renal failure
  • Acute infection of any kind in the previous 6 weeks
  • Pregnancy or a possibility of pregnancy
  • Anemia
  • Inability to undergo MR imaging based on the standard clinical criteria for MRI

The study team makes the final eligibility decision.

Where it's taking place

  • Charlottesville, Virginia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.