Cytisine vs Nicotine Replacement Therapy

NCT03249428 | Enrolling By Invitation

• 1 other identifier: 20240335-01H
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence; COPD Asthma; Mental Illness; Substance Use

Outcome Measures

Primary Outcomes (1)

• Overall Quality of Life

  To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores)

  13 weeks

Secondary Outcomes (5)

• Smoking Prevalence

  26 weeks

• Tobacco and e-cigarette (with nicotine) use

  26 weeks

• Substance use

  26 weeks

• Safety and tolerability of Cytisine or NRT

  26 weeks

• Lung function

  26 weeks

Other Outcomes (1)

• Cost-effectiveness

  26 weeks

Study Arms (2)

Nicotine Replacement Therapy (NRT)

ACTIVE COMPARATOR

Nicotine Replacement Therapy (NRT): nicotine mouth spray, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers

Drug: Nicotine replacement therapy (NRT)

Cytisine

ACTIVE COMPARATOR

Cytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day).

Drug: Cytisine

Interventions

Cytisine DRUG

Cytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day).

Cytisine

Nicotine replacement therapy (NRT) DRUG

Nicotine Replacement Therapy (NRT): nicotine mouth sprays, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers

Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Currently living in Ottawa or Toronto
• Actively used tobacco and/or nicotine products (i.e., cigarettes, vape) in the past 7 days; 2) and want to use NRT or Cytisine
• Identify as being low socioeconomic status, experiencing homelessness or at-risk for homelessness, and/or racialized
• Available for in-person follow-ups for six months

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Bridge Engagement Centre

Ottawa, Ontario, K1K 4B7, Canada

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Mental Disorders; Substance-Related Disorders

Interventions

cytisine; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Smita Pakhale, MD, MSc

  The Ottawa Hospital, Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff analyzing the data and members of the data and safety monitoring committee will be blinded to the treatment. allotment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: November 4, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)