E-Cigarette Inner City RCT

Summary

Participation Requirements

Description

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: Homele...

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.

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