NCT03249428.

Study name	E‐cigarette inner city RCT A community‐based participatory action pragmatic randomized controlled trial using electronic‐cigarette for tobacco dependence in the inner city population with a holistic approach
Methods	RCT. Randomized cross‐over assignment. Multicentre  3‐yr multicentre pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of nicotine e‐cigarettes (e‐cigs) (with counselling) with peer‐led PROMPT strategy (nicotine replacement therapy (NRT) and counselling) for tobacco dependence in the inner city population. Setting: Setting: 1) The Bridge Engagement Centre, Ottawa, adjacent to the largest homeless shelter downtown; and 2) Nicotine Dependence Clinic, Center for Addiction and Mental Health, catering for Toronto's inner city population downtown. Canada
Participants	Estimated enrolment: 200 Toronto and Ottawa inner city homeless/at‐risk for homelessness participants using poly‐substances Inclusion criteria: using poly‐substances within the past year, excluding marijuana or alcohol; ≥ 16 yrs; living in Ottawa or Toronto over the past 3 mths Exclusion criteria: consent declined; planning on accessing addictions treatment (inpatient drug rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow‐up; currently or recently (in the past 30 days) enrolled in any other smoking cessation programme or have used/is using any EC (nicotine or non‐nicotine) in the past 60 days; terminal illness with a life expectancy of less than 3 months
Interventions	EC: cig‐a‐like NJOY Recharge Active comparator: Nicotine replacement therapy & one‐on‐one counselling  Standard NRT such as the nicotine patch, gum, inhaler, and/or lozenge as per participant liking and clinical indication deemed necessary by the expert smoking cessation nurse. Counseling will include a number of approaches such as reviewing smoking history, development and revision of a reduced or quit plan, encouragement of self‐monitoring, review of triggers and challenges, and coping skills. Active comparator: Electronic nicotine delivery systems (EC) & one‐on‐one counselling EC with nicotine. Counseling will include a number of approaches such as reviewing smoking history, development and revision of a reduced or quit plan, encouragement of self‐monitoring, review of triggers and challenges, and coping skills.
Outcomes	12, 26 and 52 weeks Quality of life (QOL) measured by questionnaire (EQ‐5D‐5L scores) at 26 weeks Smoking prevalence: biochemically validated 7‐day point prevalence smoking abstinence
Starting date	Estimated study start date Sept 2019. Estimated primary completion date delayed
Contact information	Smita Pakhale, MD 613‐737‐8899 ext 79979 spakhale@ohri.ca Sadia Jama, MSc 613‐518‐7172 sajama@ohri.ca
Notes	Contacted authors July 2022; study delayed New to 2022 update