NCT04092387.

Study name	Low nicotine content cigarettes in vulnerable populations: women of reproductive age
Methods	RCT Setting: Johns Hopkins University and the University of Vermont, USA
Participants	Estimated enrolment 246 Inclusion criteria: Female 21 to 44 years old
Interventions	EC: type not specified, 'normal nicotine content cigarette and ... a reduced nicotine content cigarette' Cigarettes with varying nicotine content E‐Cigarettes Arm 1: Cigarettes with varying nicotine content. Altering the nicotine content of the tobacco research cigarette. Research Cigarettes #1 Arm 2: Cigarettes with varying nicotine content. Altering the nicotine content of the tobacco research cigarette. Research Cigarettes #2 Arm 3: Cigarettes with varying nicotine content. Altering the nicotine content of the tobacco research cigarette E‐Cigarettes. 1) Altering the availability of e‐cigarettes; 2) Altering option to personalize the e‐liquid in the e‐cig condition Research Cigarettes #2 plus E‐cigarettes #1 Arm 4: Cigarettes with varying nicotine content. Altering the nicotine content of the tobacco research cigarette E‐Cigarettes. 1) Altering the availability of e‐cigarettes; 2) Altering option to personalize the e‐liquid in the e‐cig condition. Research Cigarettes #2 plus E‐cigarettes #2
Outcomes	16 weeks Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total cpd, cigarette demand assessed by behavioural economics‐based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO])
Starting date	Start date: September 18 2019. Estimated study completion date: July 2023.
Contact information	Catherine Markesich 8026569981, cmarkesi@uvm.edu
Notes	New to 2022 update