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

NCT05658471 | Completed

• 2 other identifiers: SREC225U01DA045519-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Tobacco Toxicity; Cardiovascular Risk Factors

Keywords

Nicotine Pharmacokinetics; Nicotine Pharmacodynamics; Electronic Cigarettes; E-Cigarettes

Outcome Measures

Primary Outcomes (8)

• Mean Peak Nicotine Concentration

  The investigators will compare peak nicotine concentrations between SREC vs. EC use

  Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session

• Mean Time of Peak Nicotine Concentration

  Compare peak nicotine concentration between SREC vs. EC use.

  Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session

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

  Compare peak nicotine concentration between SREC vs. EC

  Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session

• Mean overall systemic nicotine exposure

  Descriptive statistics will be used to examine systemic nicotine exposure from use of SREC and compare to EC

  during the 3 hr of ad libitum use

• 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.

  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.

  Up to 1 month

• 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

  Up to 1 month

• 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

  Up to 1 month

Secondary Outcomes (6)

• Mean acrolein levels within participants

  Up to 1 month

• Mean propylene oxide levels within participants

  Up to 1 month

• Median benzene levels within participants

  Up to 1 month

• Mean heart rate within participants

  Up to 1 month

• Mean blood pressure (both systolic and diastolic) within participants

  Up to 1 month

Study Arms (2)

Usual Brand E-Cigarette (EC) then SREC

EXPERIMENTAL

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.

Other: Standardized Research E-Cigarette (SREC); Other: Over the Counter E-Cigarette (EC); Behavioral: Biological Samples; Other: Smoking-related Questionnaires

SREC then Usual Brand E-Cigarette (EC)

EXPERIMENTAL

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.

Other: Standardized Research E-Cigarette (SREC); Other: Over the Counter E-Cigarette (EC); Behavioral: Biological Samples; Other: Smoking-related Questionnaires

Interventions

Over the Counter E-Cigarette (EC) OTHER

Usual brand e-cigarettes will be provided at the hospital stay.

Also known as: Usual Brand E-Cigarette (EC)

SREC then Usual Brand E-Cigarette (EC); Usual Brand E-Cigarette (EC) then SREC

Standardized Research E-Cigarette (SREC) OTHER

Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay.

SREC then Usual Brand E-Cigarette (EC); Usual Brand E-Cigarette (EC) then SREC

Biological Samples BEHAVIORAL

Blood, urine, and expired carbon dioxide will be obtained during the course of the study.

Also known as: Biological Specimens

SREC then Usual Brand E-Cigarette (EC); Usual Brand E-Cigarette (EC) then SREC

Smoking-related Questionnaires OTHER

Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays.

Also known as: Behavioral Questionnaires

SREC then Usual Brand E-Cigarette (EC); Usual Brand E-Cigarette (EC) then SREC

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California, San Francisco - Tobacco Research Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Study Officials

• Neal Benowitz, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the starting condition using a Latin square design

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 20, 2022
• Study Start: February 1, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)