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Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC) (SREC22)

Primary Purpose

Nicotine Dependence, Tobacco Toxicity, Cardiovascular Risk Factors

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized Research E-Cigarette (SREC)
Over the Counter E-Cigarette (EC)
Biological Samples
Smoking-related Questionnaires
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence focused on measuring Nicotine Pharmacokinetics, Nicotine Pharmacodynamics, Electronic Cigarettes, E-Cigarettes

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy on the basis of medical history and limited physical examination- 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: The following unstable medical conditions: 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

Sites / Locations

  • University of California, San Francisco - Tobacco Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Usual Brand E-Cigarette (EC) then SREC

SREC then Usual Brand E-Cigarette (EC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean Peak Nicotine Concentration
The investigators will compare peak nicotine concentrations between SREC vs. EC use
Mean Time of Peak Nicotine Concentration
Compare peak nicotine concentration between SREC vs. EC use.
Area Under the plasma nicotine concentration-time Curve (AUC) at 120 minutes
Compare peak nicotine concentration between SREC vs. EC
Mean overall systemic nicotine exposure
Descriptive statistics will be used to examine systemic nicotine exposure from use of SREC and compare to EC
Mean inter-puff interval
The patterns of SREC puffing and EC use will be examined looking at the average and variability (SD) of inter-puff interval during the 3 hr of ad libitum use.
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
The mCEQ use three multi-item domains (subscales) and two single items: "Smoking Satisfaction", "Psychological Reward", "Aversion", "Enjoyment of Respiratory Tract Sensations" and "Craving Reduction". Scores for each subscale are calculated as the average of its individual item responses of The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely). Higher scores indicate greater intensity of each smoking effect with, for example, greater satisfaction or psychological reward after smoking. Scores will be compared between SREC and EC use.
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
The MTWS-R features two separate measures for examining the severity of nicotine withdrawal symptoms in a participant: a self-report scale and an observer scale. The observer scale asks the scale-taker to rate the severity of four symptoms in someone the they know who is experiencing nicotine withdrawal: "angry/irritable/frustrated," "anxious/tense," "depressed," and "restless/impatient." The self-report version asks for rankings of the severity of those same four symptoms, plus eleven others that cannot be observed by outsiders (including such things as "desire or craving to smoke," "insomnia, sleep problems, awakening at night," or "dizziness). Both scales use a Likert-type scale for the severity ratings, ranging from 0 ("not at all") to 4 ("severe"). These scores are tallied to calculate an a total withdrawal discomfort score and will be compared between SREC and EC use
Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about the participants desire to smoke cigarettes as the participant is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and total scores are calculated by summing the item scores to compare craving between SREC and EC use

Secondary Outcome Measures

Mean acrolein levels within participants
Urine excretion of mercapturic acid metabolites of volatile organic compounds (VOCs), with a particular focus on acrolein will be measured and compared between SREC and EC use
Mean propylene oxide levels within participants
Urine excretion of mercapturic acid metabolites of VOCs, with a particular focus on propylene oxide will be measured and compared between SREC and EC use
Median benzene levels within participants
Urine excretion of mercapturic acid metabolites of VOCs, with a particular focus on benzene will be measured and compared between SREC and EC use
Mean heart rate within participants
The cardiovascular effects of e-cigarette use as measured by heart rate will be compared between SREC and EC use
Mean blood pressure (both systolic and diastolic) within participants
The cardiovascular effects of e-cigarette use as measured by blood pressure will be compared between SREC and EC use
Mean plasma epinephrine within participants
The cardiovascular effects of e-cigarette use as measured by plasma epinephrine will be compared between SREC and EC use

Full Information

First Posted
December 9, 2022
Last Updated
February 16, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05658471
Brief Title
Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)
Acronym
SREC22
Official Title
Comparative Pharmacokinetics and Pharmacodynamics of Nicotine With Use of NIDA Standardized Research Electronic Cigarette (SREC) vs Usual Brand E-cigarette
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a crossover study that will examine use behaviors, chemical exposures, and biological effects of Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarette use in natural or synthetic nicotine users.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Tobacco Toxicity, Cardiovascular Risk Factors
Keywords
Nicotine Pharmacokinetics, Nicotine Pharmacodynamics, Electronic Cigarettes, E-Cigarettes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will be randomized to the starting condition using a Latin square design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Brand E-Cigarette (EC) then SREC
Arm Type
Experimental
Arm Description
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.
Arm Title
SREC then Usual Brand E-Cigarette (EC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standardized Research E-Cigarette (SREC)
Intervention Description
Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay.
Intervention Type
Other
Intervention Name(s)
Over the Counter E-Cigarette (EC)
Other Intervention Name(s)
Usual Brand E-Cigarette (EC)
Intervention Description
Usual brand e-cigarettes will be provided at the hospital stay.
Intervention Type
Behavioral
Intervention Name(s)
Biological Samples
Other Intervention Name(s)
Biological Specimens
Intervention Description
Blood, urine, and expired carbon dioxide will be obtained during the course of the study.
Intervention Type
Other
Intervention Name(s)
Smoking-related Questionnaires
Other Intervention Name(s)
Behavioral Questionnaires
Intervention Description
Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays.
Primary Outcome Measure Information:
Title
Mean Peak Nicotine Concentration
Description
The investigators will compare peak nicotine concentrations between SREC vs. EC use
Time Frame
Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Title
Mean Time of Peak Nicotine Concentration
Description
Compare peak nicotine concentration between SREC vs. EC use.
Time Frame
Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Title
Area Under the plasma nicotine concentration-time Curve (AUC) at 120 minutes
Description
Compare peak nicotine concentration between SREC vs. EC
Time Frame
Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Title
Mean overall systemic nicotine exposure
Description
Descriptive statistics will be used to examine systemic nicotine exposure from use of SREC and compare to EC
Time Frame
during the 3 hr of ad libitum use
Title
Mean inter-puff interval
Description
The patterns of SREC puffing and EC use will be examined looking at the average and variability (SD) of inter-puff interval during the 3 hr of ad libitum use.
Time Frame
during the 3 hr of ad libitum use
Title
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
Description
The mCEQ use three multi-item domains (subscales) and two single items: "Smoking Satisfaction", "Psychological Reward", "Aversion", "Enjoyment of Respiratory Tract Sensations" and "Craving Reduction". Scores for each subscale are calculated as the average of its individual item responses of The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely). Higher scores indicate greater intensity of each smoking effect with, for example, greater satisfaction or psychological reward after smoking. Scores will be compared between SREC and EC use.
Time Frame
Up to 1 month
Title
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
Description
The MTWS-R features two separate measures for examining the severity of nicotine withdrawal symptoms in a participant: a self-report scale and an observer scale. The observer scale asks the scale-taker to rate the severity of four symptoms in someone the they know who is experiencing nicotine withdrawal: "angry/irritable/frustrated," "anxious/tense," "depressed," and "restless/impatient." The self-report version asks for rankings of the severity of those same four symptoms, plus eleven others that cannot be observed by outsiders (including such things as "desire or craving to smoke," "insomnia, sleep problems, awakening at night," or "dizziness). Both scales use a Likert-type scale for the severity ratings, ranging from 0 ("not at all") to 4 ("severe"). These scores are tallied to calculate an a total withdrawal discomfort score and will be compared between SREC and EC use
Time Frame
Up to 1 month
Title
Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
Description
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about the participants desire to smoke cigarettes as the participant is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and total scores are calculated by summing the item scores to compare craving between SREC and EC use
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Mean acrolein levels within participants
Description
Urine excretion of mercapturic acid metabolites of volatile organic compounds (VOCs), with a particular focus on acrolein will be measured and compared between SREC and EC use
Time Frame
Up to 1 month
Title
Mean propylene oxide levels within participants
Description
Urine excretion of mercapturic acid metabolites of VOCs, with a particular focus on propylene oxide will be measured and compared between SREC and EC use
Time Frame
Up to 1 month
Title
Median benzene levels within participants
Description
Urine excretion of mercapturic acid metabolites of VOCs, with a particular focus on benzene will be measured and compared between SREC and EC use
Time Frame
Up to 1 month
Title
Mean heart rate within participants
Description
The cardiovascular effects of e-cigarette use as measured by heart rate will be compared between SREC and EC use
Time Frame
Up to 1 month
Title
Mean blood pressure (both systolic and diastolic) within participants
Description
The cardiovascular effects of e-cigarette use as measured by blood pressure will be compared between SREC and EC use
Time Frame
Up to 1 month
Title
Mean plasma epinephrine within participants
Description
The cardiovascular effects of e-cigarette use as measured by plasma epinephrine will be compared between SREC and EC use
Time Frame
Up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy on the basis of medical history and limited physical examination- 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: The following unstable medical conditions: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Lawrence
Phone
415-608-4864
Email
Lisa.Lawerence@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Bustos
Email
Angie.Bustos@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Benowitz, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco - Tobacco Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angie Bustos
Phone
415-608-4864
Email
angie.bustos@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Lisa Lawrence
Phone
628-206-4204
Email
lisa.lawrence@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Neal Benowitz, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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