NCT06164678

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

Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users: A Pilot RCT

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2024-07-11
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-12-11
• Last updated: 2026-02-05

Locations

1 site across 1 country: Canada