E-Cigarette Inner City RCT

Study Overview
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Brief Summary
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Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco use rate has substantially gone down in the general population, significant differences exist between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the rest of the Canadian general population. This stark inequity in tobacco use translates into devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart disease and death. Canadians who are homeless or at-risk for homelessness die 25 years earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use related inequity - a novel approach is urgently needed. Despite commonly held dogma that People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led community-based action approach used in their PROMPT project has demonstrated that tobacco dependence strategies can be implemented with great success in this population. The majority of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all other drug use. Importantly, the investigators have demonstrated that it is possible to gain the trust and engagement of marginalized populations and that researchers can create a community space that is low-threshold, safe and non-judgmental. The investigators aim to compare two tobacco dependence management strategies in the homeless (or at-risk for homelessness) multi-drug use population in Ottawa and Toronto. They will use the same peer-led approach in PROMPT with community peer researchers with lived experience; with the hope that the cost-effective community based framework derived from this trial will serve as a template for interventions and treatments in community settings for chronic diseases such as obesity and diabetes.

Detailed Description
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Aim: A 3-yr multi-centre, pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner city population. Background: Homelessness/at-risk for homelessness populations in Canada carry disproportionate burden of many diseases, mostly due to tobacco. With smoking rates at  100% in some subpopulations as compared to 9-18% in the general population, tobacco inequity is translated into unequal morbidity and mortality (COPD, cancers, heart diseases). Tobacco use costs the Ontario economy  $1.6 billion/yr in healthcare costs. Smoking attributable hospitalization costs  $38.2 million/yr in Ottawa alone from 2008-10. The inner city population in Canada dies  25 yrs earlier than housed Canadians, largely due to tobacco. With negligible quit rates using conventional strategies, novel approaches to address tobacco inequity are urgently needed. Study Population: 200 Toronto and Ottawa inner city homeless/ at-risk for homelessness participants using poly-substances. Primary Patient-Oriented Outcome: To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores) at 26 wks; Secondary: i) To assess effectiveness of these two strategies with biochemically validated 7-day point prevalence smoking abstinence at 12, 26 and 52 wks; ii) To assess effectiveness of these two strategies on cigarette use reduction and cessation at 12, 26 and 52 wks; iii) To assess self-reported reduction and cessation of other illicit drug use; and; iv) To describe the safety/tolerability of nicotine e-cigs serious adverse events (SAEs), adverse events (AEs), drop-outs due to side effects, and therapy adherence over 52 wks; and, v) To compare the lung function (spirometry/oscillometry), 6-min walk and self-efficacy at baseline, 26 and 52 wks; Tertiary: i) To assess the cost-effectiveness of the pragmatic tobacco dependence strategies. Study Design: A multi-centre pragmatic RCT trial comparing e-cigs (with nicotine) with counseling or NRT with counseling for a 26 wks treatment period and 52 wks follow up. Similar to the real world all participants will be given an opportunity to choose either strategy at 26 wks. The primary analysis will be change in QOL measured with EQ-5D-5L at 26 wks between participants. 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 Toronto's inner city population downtown. Expertise: Both PIs are well versed in community-based research and Dr. Pakhale led the PROMPT project, a community based smoking cessation project engaging the same target population. Together the team is very experienced in tobacco dependence and the target population. The investigators collective expertise with links to the target community will support the implementation of the trial. Outcomes: Pragmatic community-based participatory and peer-led research holds a tremendous potential in investigating solutions 'for the people, by and with the people'. Outcomes of this trial will aid policy makers in implementing effective programs to treat tobacco dependence in marginalized population. The cost-effective community based framework of this trial can be used as a template for intervention in other chronic diseases (e.g. obesity or diabetes). Timeline: The trial will require 3 yrs to complete.

Official Title
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A Community-Based Participatory Action Pragmatic Randomized Controlled Trial Using Electronic-Cigarette for Tobacco Dependence in the Inner City Population With a Holistic Approach

Conditions
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Tobacco Dependence, COPD Asthma, Mental Illness, Substance Use

Intervention / Treatment
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* Device: Improved Quality of Life of low-income Canadians that smoke tobacco and other substances


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16 years or older Living in Ottawa or Toronto over the past 3 months Using poly-substances within the past year, excluding marijuana or alcohol Exclusion Criteria: Consent declined (refusal from participant or decision maker) Any person who is in or planning on accessing addictions treatment (in-patient 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 program or have used/is using any e-cigs (nicotine or non-nicotine) in the past 60 days Terminal illness with a life expectancy of less than 3 months

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3-yr multi-centre pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner city population.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine Replacement Therapy & One-on-One Counseling<br>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. | Device: Improved Quality of Life of low-income Canadians that smoke tobacco and other substances<br>* Assess effectiveness, safety and tolerability of electronic-cigarettes (e-cigs) with nicotine or Nicotine Replacement Therapy (NRT) with individual counseling for tobacco cessation.<br>* Other names: Nicotine Replacement Therapy;|
| Active Comparator: Electronic Nicotine Delivery Systems & One-on-One Counseling<br>Electronic Nicotine Delivery Systems 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. | Device: Improved Quality of Life of low-income Canadians that smoke tobacco and other substances<br>* Assess effectiveness, safety and tolerability of electronic-cigarettes (e-cigs) with nicotine or Nicotine Replacement Therapy (NRT) with individual counseling for tobacco cessation.<br>* Other names: Nicotine Replacement Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Quality of Life | To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores) at 26 weeks | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Prevalence | To assess effectiveness of these two strategies with biochemically validated 7-day point prevalence smoking abstinence at 12, 26 and 52 weeks | 52 weeks |