E-Cigarette Inner City RCT

• ClinicalTrials.gov Identifier: NCT03249428
• Recruitment Status: Unknown
• First Posted: August 15, 2017
• Last Update Posted: March 21, 2019
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Dependence; COPD Asthma; Mental Illness; Substance Use	Device: Improved Quality of Life of low-income Canadians that smoke tobacco and other substances	Not Applicable

Detailed 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: 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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 (Investigator, Outcomes Assessor)
• Masking Description: Research staff analyzing the data and members of the data and safety monitoring committee will be blinded to the treatment. allotment.
• Primary Purpose: Treatment
• Official Title: A Community-Based Participatory Action Pragmatic Randomized Controlled Trial Using Electronic-Cigarette for Tobacco Dependence in the Inner City Population With a Holistic Approach
• Estimated Study Start Date: September 2019
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nicotine Replacement Therapy & One-on-One Counseling; 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; Assess effectiveness, safety and tolerability of electronic-cigarettes (e-cigs) with nicotine or Nicotine Replacement Therapy (NRT) with individual counseling for tobacco cessation.; Other Names: NJOY Recharge BOLD; Nicotine Replacement Therapy
Active Comparator: Electronic Nicotine Delivery Systems & One-on-One Counseling; 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; Assess effectiveness, safety and tolerability of electronic-cigarettes (e-cigs) with nicotine or Nicotine Replacement Therapy (NRT) with individual counseling for tobacco cessation.; Other Names: NJOY Recharge BOLD; Nicotine Replacement Therapy

Outcome Measures

Primary Outcome Measures :

1. Overall Quality of Life [ Time Frame: 26 weeks ]
   To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores) at 26 weeks

Secondary Outcome Measures :

1. Smoking Prevalence [ Time Frame: 52 weeks ]
   To assess effectiveness of these two strategies with biochemically validated 7-day point prevalence smoking abstinence at 12, 26 and 52 weeks

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Smita Pakhale, MD; 613-737-8899 ext 79979; spakhale@ohri.ca

Locations

Canada, Ontario

The Bridge Engagement Centre

Ottawa, Ontario, Canada, K1G 5T2

Contact: Smita Pakhale, MD, MSc 613-737-8899 ext 79428

Contact: Sadia Jama, MSc 613-518-7172 sajama@ohri.ca

Sponsors and Collaborators

Ottawa Hospital Research Institute

More Information

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03249428
• Other Study ID Numbers: E-Cigarette Inner City RCT 001
• First Posted: August 15, 2017
• Last Update Posted: March 21, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Substance-Related Disorders; Tobacco Use Disorder; Mental Disorders; Chemically-Induced Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action