125
Participants
Start Date
May 11, 2022
Primary Completion Date
July 19, 2025
Study Completion Date
January 20, 2026
Standardized Research E-cigarette (SREC)
The device operates at a single output voltage (3.30 ± 0.05 V) and uses sealed disposable 3-mL cartridges with tobacco-flavored e-liquid (\~350 puffs/cartridge). The concentration of nicotine in e-liquid is 15 mg/mL, and the vehicle composition is 50:50 propylene glycol and glycerin. The device uses a battery that can be recharged via a micro USB port. A single charge is designed to sustain more than 400 puffs, which is more than the capacity of an e-liquid cartridge. The e-liquid and the aerosol are well-characterized in terms of chemical impurities and by-products (such as aldehydes), which are minimal. Additional information, including the results of pharmacokinetics study is available via NIDA website: https://www.drugabuse.gov/funding/supplemental-information-nida-e-cig
Nicotine Mini-Lozenge
We will use commercially available nicotine mini-lozenges containing 2 or 4 mg nicotine/lozenge (Nicorette, manufactured by GlaxoSmithKline). Dose will be determined per instructions on the package (e.g, if smoking within 30 minutes upon awakening, then 4 mg dose will be prescribed).
RECRUITING
University of Minnesota, Masonic Cancer Center, Minneapolis
National Institute on Drug Abuse (NIDA)
NIH
Masonic Cancer Center, University of Minnesota
OTHER