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Active, Not Recruiting

NCT Number: NCT06164678

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMSC

Behavioral

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

Primary outcomes

  1. Vaping Cessation

    Time frame: baseline to 3 months

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

Secondary outcomes

  1. Continuous Abstinence

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

    Continuous abstinence rates at 1-day, 7-day, 1-month, 3-month, 6-month, and 12-month follow up.

  2. Successful cessation

    Time frame: 12 month assessment

    Self-reported cessation will be measured by a self-administered salivary cotinine test.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: VC-OMSC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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