Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U01DA045519-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Research E-Cigarette (SREC) | Other | Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 1 month |
| Mean propylene oxide levels within participants |
Not provided
Inclusion Criteria:
Healthy on the basis of medical history and limited physical examination-
Current regular user of electronic cigarettes (EC)
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:
Medications
Other/Misc. Health Conditions
Pregnancy
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neal Benowitz, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco - Tobacco Research Center | San Francisco | California | 94143 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomized to the starting condition using a Latin square design
Not provided
Not provided
Not provided
Not provided
| Over the Counter E-Cigarette (EC) | Other | Usual brand e-cigarettes will be provided at the hospital stay. |
|
|
| Biological Samples | Behavioral | Blood, urine, and expired carbon dioxide will be obtained during the course of the study. |
|
|
| Smoking-related Questionnaires | Other | Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays. |
|
|
| 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 |
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 |
| Up to 1 month |
| 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 | Up to 1 month |
| 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 | Up to 1 month |
| 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 | Up to 1 month |
| 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 | Up to 1 month |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
| D001519 | Behavior |
Not provided
Not provided