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Electronic Cigarettes for Cardiovascular Risk (TCORS-2 Trial)

Q: Are there any open enrollment opportunities for this experiment?

<p>At present, clinicaltrials.gov reports that this research project is taking in new participants; the initial posting occurred on April 1st 2021 and was recently adjusted on May 17th 2022.</p>

N/A

Recruiting

Led By Gideon St. Helen, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Smoke 10 or fewer cigarettes/tobacco products per day in the last 30 days

Age: > 21 years old and < 70 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of each arm

Awards & highlights

TCORS-2 Trial Summary

This trial will study the short-term effects of e-liquid pH on the heart and blood vessels in experienced e-cigarette users.

Who is the study for?

Adult e-cigarette users aged 21-70 with a heart rate <105 BPM, systolic BP between 90-160, diastolic BP between 50-100, BMI <38.0, and using nicotine-containing e-liquid can join this study. They must smoke ≤10 tobacco products per day and have used e-cigarettes for at least 3 months. Participants need to abstain from tobacco the night before the study.Check my eligibility

What is being tested?

The trial is testing how different pH levels in e-cigarette liquid affect short-term cardiovascular health, nicotine effects on the body, and personal feelings about using e-cigarettes. It's a randomized crossover study where participants will try various liquids.See study design

What are the potential side effects?

Potential side effects may include changes in heart rate or blood pressure due to nicotine intake from e-cigarettes. Other common reactions might be throat irritation or coughing associated with vaping.

TCORS-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have smoked 10 or fewer cigarettes daily in the past month.

Select...

I am between 22 and 69 years old.

Select...

I use e-liquid that contains nicotine.

TCORS-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of each arm

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of each arm

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of each arm for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiovascular Effects: Heart Rate

Cardiovascular Effects: Skin Blood Flow

Nicotine

+4 more

Secondary outcome measures

Vaping Topography: Inter-Puff Interval

Vaping Topography: Puff Duration

Vaping Topography: Puff Number

TCORS-2 Trial Design

3Treatment groups

Experimental Treatment

Group I: Remaining e-liquid pHExperimental Treatment1 Intervention

Using an electronic cigarette, the patient will participate in a standardized vaping session using the remaining assigned e-liquid pH.

Group II: E-liquid pH 5, 7, or 9Experimental Treatment1 Intervention

Using an electronic cigarette, the patient will participate in a standardized vaping session using 1 of 3 assigned e-liquid pH.

Group III: 1 of the other 2 remaining e-liquid pHExperimental Treatment1 Intervention

Using an electronic cigarette, the patient will participate in a standardized vaping session using 1 of the other 2 assigned e-liquid pH.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,347 Total Patients Enrolled

2 Trials studying Cardiovascular Risk

78 Patients Enrolled for Cardiovascular Risk

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,851,027 Total Patients Enrolled

11 Trials studying Cardiovascular Risk

15,689 Patients Enrolled for Cardiovascular Risk

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,534 Total Patients Enrolled

8 Trials studying Cardiovascular Risk

1,182 Patients Enrolled for Cardiovascular Risk

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this experiment?

"At present, clinicaltrials.gov reports that this research project is taking in new participants; the initial posting occurred on April 1st 2021 and was recently adjusted on May 17th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Short-Term Cardiovascular Effects of E-Cigarettes: Influence of E-Liquid pH

2021. "Short-Term Cardiovascular Effects of E-Cigarettes: Influence of E-Liquid pH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04449510.