Status:
COMPLETED
Impact of Flavors on Nicotine Perception and Self-Administration Via E-cigarettes
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine
E-liquid Flavors
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief 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.
Detailed Description
This study examines the impact of menthol and fruit flavors on self-administration of e-cigarette solutions containing varying amounts of nicotine. This is a randomized, double-blind study with a with...
Eligibility Criteria
Inclusion
- 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 dependence or tobacco product use (smoking or vaping) or has current plans to quit tobacco product use;
- Meet current criteria for psychiatric disorder (according to the MINI);
- Current or history of respiratory illnesses including pneumonia with COVID-19 , other medical illness, and/or psychotropic medication use that a clinician investigator deems a contraindication for study participation.
- History of environmental - bronchospastic allergies, multiple chemical sensitivities, or other airway sensitivities that require the use of an epi pen or that in the investigators view would make it risky for participation;
- Not fully vaccinated for COVID-19
Exclusion
Key Trial Info
Start Date :
October 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04038515
Start Date
October 27 2022
End Date
June 3 2024
Last Update
August 5 2024
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06511