Smoking Cessation Program for Vaping (VC-OMSC Trial)

N/A

Recruiting

Led By Hassan Mir, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if providing counseling and Nicotine Replacement Therapy (NRT) can help e-cigarette users quit vaping. Participants will be randomly assigned to receive either counseling and NRT or just

Who is the study for?

This trial is for Ontario residents over 18 who vape at least once a week and have been doing so for the past month. Participants must be able to speak English or French. It's designed to help e-cigarette users quit vaping.

What is being tested?

The study tests if counselling combined with Nicotine Replacement Therapy (NRT) is more effective in helping people stop vaping than counselling alone. Participants will be randomly assigned to one of these two approaches and tracked for a year.

What are the potential side effects?

Potential side effects may include those commonly associated with NRT, such as nausea, headaches, skin irritation from patches, insomnia, and dizziness. Counselling itself has no physical side effects but can sometimes bring up uncomfortable emotions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vaping Cessation

Secondary study objectives

Continuous Abstinence

Successful cessation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ottawa Model for Smoking CessationExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 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.

0 / 1Eligibility criteria met