Study Title: Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial 

Sponsor: Lady Davis Institute / Jewish General Hospital, Montreal, QC

CTO #4219

ClinicalTrials.gov ID: NCT05257629

The ASAP trial is a multi-centre RCT, with an open-label treatment period of 12 weeks, and a follow-up duration of 52 weeks among patients at elevated cardiovascular risk who are motivated to quit smoking. Patients who meet the eligibility criteria and give their informed consent will be randomized (1:1) to one of the two treatment arms: (1) combination therapy of varenicline and nicotine e-cigarettes plus counselling, or (2) varenicline plus counselling. Regardless of which treatment arm the participants are randomized to, they will be provided with the varenicline medication and counselling by the study team. Those who are randomized to the combination therapy arm will additionally receive funds to purchase an e-cigarette with the following characteristics: rechargeable (including rechargeable disposables), closed system that uses sealed cartridges/pods or tanks, tobacco or no flavour only, and nicotine strength of 20 mg/ml (2%) or less.

The primary objective is to assess the efficacy of randomization to a combined therapy of varenicline and nicotine e-cigarettes plus counselling versus varenicline plus counselling for 12 weeks on biochemically-validated (via carbon monoxide measure) 7-day point prevalence abstinence at 24 weeks among people at elevated cardiovascular risk.