Impact of Flavors on Nicotine Perception and Self-Administration Via E-cigarettes (NCT04038515) | Clinical Trial Compass
CompletedPhase 2
Impact of Flavors on Nicotine Perception and Self-Administration Via E-cigarettes
United States54 participantsStarted 2022-10-27
Plain-language summary
The goal of this application is to test whether menthol and fruit flavors impact e-cigarette use through dissociable mechanisms and exert their effects differentially across nicotine doses.
Who can participate
Age range18 Years – 30 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
* Aged 18 to 30;
* Past month daily nicotine-containing e-cigarette, cigarette, and/or cigar/little cigar/cigarillo use;
* Urine cotinine levels consistent with regular nicotine use (e.g., NicAlert urine cotinine dipstick ≥3 or Accutest Positive for Cotinine);
* For females, using acceptable birth control methods;
* Able to provide written informed consent;
* Able to read and write in English;
* Stated willingness to comply with all study procedures (including self-administration of all e-liquid conditions; attend in-person sessions; comply with COVID guidelines of the research facilities) and lifestyle considerations (including overnight nicotine abstinence) and availability for the duration of the study;
* Cardiovascular measures in normal/ non-hypertensive range for adults, including resting heart rate (HR) of 60-100 bpm; blood pressure (BP) of equal to or less than 129 mmHg (systolic)/80 mmHg (diastolic)); and oximeter (i.e., blood oxygenation) readings of 95-100 SpO2;
* Resident of the State of Connecticut.
Exclusion Criteria:
* Any allergy or known hypersensitivity to propylene glycol, vegetable glycerin, menthol, mint, green apple or watermelon flavorants or history of allergic or hypersensitive reaction to use of an e-cigarette/vaping device;
* Has not used e-cigarettes at least 10 times in the last 6 months;
* For females, pregnant (as determined by pregnancy screening) or breast feeding;
* Seeking (or undergoing) treatment for nicotine dependen…