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E-Cigarettes for Nicotine Addiction (SREC22 Trial)

Q: What are the eligibility criteria for participating in this research?

Admission to this trial is open for those who suffer from nicotine dependence and are between 21 and 70 years old. The total number of enrollees needed is 20 individuals.

Q: Is it possible to enroll in this clinical experiment at present?

Clinicaltrials.gov indicates that this clinical trial, which first went up on January 31st 2023 and was last updated December 16th 2022, is not presently enrolling patients. Nevertheless, there are 186 other studies actively recruiting at the moment.

Q: Is this experimental procedure available to adults aged 18 and over?

As outlined in the study details, eligible participants must be between 21-70 years old.

Q: What goals are researchers looking to accomplish through this clinical trial?

This research project, which will evaluate the effects of vaping over a period of 2, 5, 7, 10, 15, 30, 45 and up to 120 minutes post-inhalation seeks to measure peak nicotine concentration. Secondary objectives include assessing urinary excretion of mercapturic acid metabolites such as propylene oxide and benzene between different e-cigarette users compared with traditional smokers; additionally blood pressure measurements for both systolic and diastolic readings are being taken into consideration.

N/A

Recruiting

Led By Neal Benowitz, MD

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month

Awards & highlights

SREC22 Trial Summary

This trial looks at how e-cigarettes affect people's health and behavior compared to traditional cigarettes.

Who is the study for?

This trial is for adults aged 21-70 who regularly use e-cigarettes, have a heart rate under 105 BPM, BMI <=38.0, and blood pressure within certain limits. They must not be planning to quit smoking soon or have serious health issues like heart disease, seizures, cancer, diabetes, or severe lung conditions.Check my eligibility

What is being tested?

The study compares the effects of using a Standardized Research E-Cigarette (SREC) versus regular e-cigarettes on behavior, chemical exposure and biological impact in users of natural or synthetic nicotine through a crossover design.See study design

What are the potential side effects?

Potential side effects may include irritation from inhalation of vapor substances such as propylene glycol/vegetable glycerin (to which some individuals are allergic), changes in cardiovascular parameters due to nicotine intake and possible discomfort from biological sample collection.

SREC22 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Area Under the plasma nicotine concentration-time Curve (AUC) at 120 minutes

Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)

Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)

+5 more

Secondary outcome measures

Mean acrolein levels within participants

Mean blood pressure (both systolic and diastolic) within participants

Mean heart rate within participants

+3 more

SREC22 Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual Brand E-Cigarette (EC) then SRECExperimental Treatment4 Interventions

Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the usual brand of e-cigarette that participants utilize for nicotine use, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the SREC.

Group II: SREC then Usual Brand E-Cigarette (EC)Experimental Treatment4 Interventions

Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the SREC, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the usual brand of e-cigarette that participants utilize for nicotine use.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biological Samples

2019

N/A

~430

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,535 Total Patients Enrolled

2 Trials studying Nicotine Addiction

991 Patients Enrolled for Nicotine Addiction

National Institute on Drug Abuse (NIDA)NIH

2,467 Previous Clinical Trials

2,619,103 Total Patients Enrolled

15 Trials studying Nicotine Addiction

2,130 Patients Enrolled for Nicotine Addiction

Neal Benowitz, MDPrincipal InvestigatorUniversity of California, San Francisco

2 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Over the Counter E-Cigarette (EC) Clinical Trial Eligibility Overview. Trial Name: NCT05658471 — N/A

Nicotine Addiction Clinical Trial 2023: Over the Counter E-Cigarette (EC) Highlights & Side Effects. Trial Name: NCT05658471 — N/A

Over the Counter E-Cigarette (EC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05658471 — N/A

Frequently Asked Questions

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

What are the eligibility criteria for participating in this research?

"Admission to this trial is open for those who suffer from nicotine dependence and are between 21 and 70 years old. The total number of enrollees needed is 20 individuals."

Answered by AI

Is it possible to enroll in this clinical experiment at present?

"Clinicaltrials.gov indicates that this clinical trial, which first went up on January 31st 2023 and was last updated December 16th 2022, is not presently enrolling patients. Nevertheless, there are 186 other studies actively recruiting at the moment."

Answered by AI

Is this experimental procedure available to adults aged 18 and over?

"As outlined in the study details, eligible participants must be between 21-70 years old."

Answered by AI

What goals are researchers looking to accomplish through this clinical trial?

"This research project, which will evaluate the effects of vaping over a period of 2, 5, 7, 10, 15, 30, 45 and up to 120 minutes post-inhalation seeks to measure peak nicotine concentration. Secondary objectives include assessing urinary excretion of mercapturic acid metabolites such as propylene oxide and benzene between different e-cigarette users compared with traditional smokers; additionally blood pressure measurements for both systolic and diastolic readings are being taken into consideration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)

2023. "Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05658471.