Clinical trial NCT06164678: Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Official title: Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Vaping
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized 1:1
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* \>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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Vaping Cessation
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Continuous Abstinence
timeFrame: 1-day, 7-day, 1-month, 3-month, 6-month, and 12-month from baseline date
measure: Successful cessation
timeFrame: 12 month assessment
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Hassan Mir, MD
role: PRINCIPAL_INVESTIGATOR
References: