Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)
NCT ID: NCT05658471
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-02-01
2026-01-31
Brief Summary
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Detailed Description
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I. To characterize nicotine delivery, systemic exposure and effects from SREC in comparison with usual to usual nicotine brand use.
II. To assess aspects of harm of SREC use compared to usual nicotine brand use.
OUTLINE:
Eligible participants will be assigned to one of two treatment conditions for the initial assessment which will take place in a hospital setting. The participant will then be assigned to the second condition within 2 weeks after the initial assessment which will also take place in a hospital setting to repeat the same procedures.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Usual Brand E-Cigarette (EC) then SREC
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.
Standardized Research E-Cigarette (SREC)
Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay.
Over the Counter E-Cigarette (EC)
Usual brand e-cigarettes will be provided at the hospital stay.
Biological Samples
Blood, urine, and expired carbon dioxide will be obtained during the course of the study.
Smoking-related Questionnaires
Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays.
SREC then Usual Brand E-Cigarette (EC)
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.
Standardized Research E-Cigarette (SREC)
Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay.
Over the Counter E-Cigarette (EC)
Usual brand e-cigarettes will be provided at the hospital stay.
Biological Samples
Blood, urine, and expired carbon dioxide will be obtained during the course of the study.
Smoking-related Questionnaires
Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays.
Interventions
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Standardized Research E-Cigarette (SREC)
Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay.
Over the Counter E-Cigarette (EC)
Usual brand e-cigarettes will be provided at the hospital stay.
Biological Samples
Blood, urine, and expired carbon dioxide will be obtained during the course of the study.
Smoking-related Questionnaires
Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Heart rate \< 105 beats per minute (BPM)\*.
* Systolic Blood Pressure \< 160 and \> 90\*.
* Diastolic Blood Pressure \< 100 and \> 50\*.
* \*considered out of range if both machine and manual readings are above/below these thresholds.
* Body Mass Index \<= 38.0.
* Current regular user of electronic cigarettes (EC)
* EC device use at least 15 or more days in the past 30 days (with e- liquid \>= 3mg/ml)
* No restriction on flavor or type of e-cigarette used
* Saliva cotinine \>= 50 ng/ml and/or NicAlert = 6
* Age \>= 21 years old \<= 70 years old
* Willingness to abstain from drug use for the duration of the study
Exclusion Criteria
* Heart disease
* Seizures
* Cancer
* Thyroid disease (okay if controlled with medication)
* Diabetes
* Hepatitis B or C or Liver disease
* Glaucoma
* Kidney disease or urinary retention
* History of stroke
* An ulcer in the past year
* Active use of an inhaler for Asthma or chronic obstructive pulmonary disease (COPD)
* Medications
* Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
* Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
* Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
* Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment.
* Other/Misc. Health Conditions
* Oral thrush
* Fainting (within the last 30 days)
* Other "life threatening illnesses" as per principal investigator and/or study physician's discretion
* Pregnancy
* Pregnancy (self-reported and urine pregnancy test)
* Breastfeeding (determined by self-report)
* Women of childbearing potential must be using an acceptable method of contraception
* Concurrent participation in another clinical trial.
* Inability to read and write in English
* Planning to quit smoking or vaping within the next 60 days
* A known propylene glycol/vegetable glycerin allergy
* Uncomfortable with getting blood drawn
* Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
21 Years
70 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Neal Benowitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco - Tobacco Research Center
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SREC22
Identifier Type: -
Identifier Source: org_study_id
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