Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users

NCT06164678 | Active Not Recruiting

• 1 other identifier: 20230670-01H
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if a standardized approach including counselling and Nicotine Replacement Therapy (NRT) can help e-cigarette users quit vaping. Current e-cigarette users will be randomly assigned to either to counselling and NRT or counselling only group. Self-reported rates of vaping cessation will be measured throughout the year in both groups. The use of e-cigarettes has grown substantially among non-smokers, particularly among youth and young adults. These devices deliver high levels of nicotine, far greater than is possible with conventional cigarettes. Currently, they are not approved for smoking cessation or any purpose by Health Canada. Nonetheless, there is some evidence that e-cigarettes may be of assistance in smoking cessation. Conversely, there is evidence that using cigarettes and e-cigarettes together may result in increased cigarette consumption. E-cigarette use among youth also serves as a gateway to regular use of conventional cigarettes. Clinicians and patients are seeking guidance on vaping cessation. However, to date, there are no strong evidence-based interventions to support e-cigarette users in quitting. NRT is approved for smoking cessation by Health Canada. However, it is not approved for vaping cessation and thus its use to support e-cigarette users to quit by managing their nicotine withdrawal is considered "off-label". This represents a significant gap and opportunity, which this project will address. The study hypothesizes that the OMSC approach, which includes the use of nicotine replacement therapy, will result in higher rates of vaping cessation compared to usual care. Participants will all complete an initial counselling session to discuss vaping cessation and receive tips to help achieve cessation. They will all be asked to track their smoking/vaping behaviour and the amount of tobacco in their e-cigarette for 7 days. After 7 days, all participants will be randomly put into one of two groups (either the intervention or control group). They will have follow-up assessments with the research team at 1, 3, 6 and 12 months.

Conditions

Tobacco Smoking; Vaping

Outcome Measures

Primary Outcomes (1)

• Vaping Cessation

  7-day point prevalence of vaping cessation measured at 3-months.

  baseline to 3 months

Secondary Outcomes (2)

• Continuous Abstinence

  1-day, 7-day, 1-month, 3-month, 6-month, and 12-month from baseline date

• Successful cessation

  12 month assessment

Study Arms (2)

Ottawa Model for Smoking Cessation

EXPERIMENTAL

The OMSC group will receive counselling and pharmacotherapy if they choose (specifically NRT) with follow-up calls to support medication titration. Participants will be provided with quit cards, which are pre-loaded with $300 worth of funds that can only be used by the assigned study participant to purchase NRT (if they choose). For those in the intervention group, the study counsellor who is a trained Nicotine Addiction Treatment Specialist (NATS) will facilitate follow-up, monitor NRT use, and advise participants to titrate NRT dose as required based on their minimum daily nicotine intake. These counselling calls will be conducted at day 3, 7, 14, 21, 30, 60, 90, and 180 as is standard in OMSC for people who smoke and are interested in quitting. A diary will also be provided to the participants to track their usage.

Behavioral: OMSC

Usual Care

NO INTERVENTION

The usual care group will receive the initial counselling session but no further follow-up or NRT. They will be able to self-initiate a follow-up call if they choose. Participants will not be excluded if they choose to initiate NRT on their own at their own expense.

Interventions

OMSC BEHAVIORAL

The OMSC program uses a counselling approach to assist clients with tobacco cessation. If required, nicotine replacement therapy may be offered.

Ottawa Model for Smoking Cessation

Eligibility Criteria

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

You may qualify if:

• \>18 years of age or older
• Ontario resident
• Ability to speak English or French
• Regular use of e-cigarette (vaping at least once per week for the past four weeks)

You may not qualify if:

• Cognitive impairment or acute psychiatric illness that would alter their ability to participate
• Being institutionalized at a retirement home, nursing home or long-term care facility
• Participating in another smoking or vaping cessation program
• Allergy or intolerance to NRT

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Tobacco Smoking; Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Officials

• Hassan Mir, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A blinded member of the research team will complete all follow-up assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: July 11, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)