Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study
Nicotine Dependence
About this trial
This is an interventional prevention trial for Nicotine Dependence
Eligibility Criteria
Inclusion Criteria:
- Willingness to abstain from using ENDS product for 8-10 hours (overnight abstinence) prior to study visits
Current daily ENDS user as determined by
- Has used ENDS product every day for the past 6 months (by history)
- Has used ENDS product or e-liquid containing nicotine (by history)
- Participant or legal representative must understand the investigational nature of this study and sign and Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Smoked cigarettes in the past 7 days
- Currently smokes >= 5 cigarettes per month
- Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, or glaucoma) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current regular use of psychiatric medications (such as major tranquilizers and antidepressants)
- History of serious side effects from nicotine or from any nicotine replacement therapies
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing females
- Concurrent participation in another clinical trial
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate
Sites / Locations
- Roswell Park Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Low Nicotine (nicotine vapor) 24 mg.ml
High Nicotine (nicotine vapor) 42 mg.ml
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours, 5-7 days apart. During each session, participants take 20 puffs over 10 minutes (one puff every 30 seconds) of vaporizer filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours, 5-7 days apart. During each session, participants take 20 puffs over 10 minutes (one puff every 30 seconds) of vaporizer filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.