Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Ci… (NCT05658471) | Clinical Trial Compass
CompletedNot Applicable
Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)
United States32 participantsStarted 2023-02-01
Plain-language 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.
Who can participate
Age range21 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 medi…
What they're measuring
1
Mean Peak Nicotine Concentration
Timeframe: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
2
Mean Time of Peak Nicotine Concentration
Timeframe: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
3
Area Under the plasma nicotine concentration-time Curve (AUC) at 120 minutes
Timeframe: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
4
Mean overall systemic nicotine exposure
Timeframe: during the 3 hr of ad libitum use
5
Mean inter-puff interval
Timeframe: during the 3 hr of ad libitum use
6
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
Timeframe: Up to 1 month
7
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)