Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users

PHASE1RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

May 11, 2022

Primary Completion Date

July 19, 2025

Study Completion Date

January 20, 2026

Conditions
Smoking, Cigarette
Interventions
DRUG

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

DRUG

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).

Trial Locations (1)

55455

RECRUITING

University of Minnesota, Masonic Cancer Center, Minneapolis

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Masonic Cancer Center, University of Minnesota

OTHER