Smoking Cessation Program for Vaping

(VC-OMSC Trial)

Overseen By Nia Patel, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Cognitive impairment, Acute psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of nicotine replacement therapy (NRT) combined with counseling in helping people quit vaping. Participants will be divided into two groups: one will receive both NRT and counseling, while the other will receive only counseling. The goal is to determine which approach helps more people stop vaping over a year. Ideal participants are Ontario residents who have vaped at least once a week for the past month.

As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could shape future vaping cessation strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the research team or your doctor.

What prior data suggests that this program is safe for vaping cessation?

Research has shown that Nicotine Replacement Therapy (NRT) is generally safe and effective for helping people quit smoking. Health Canada has approved NRT for this purpose. However, it has not been officially approved for quitting vaping, so using it for vaping is considered "off-label," meaning it is used in a way not officially sanctioned.

A study on the Ottawa Model for Smoking Cessation (OMSC), which includes NRT, found that it helps people quit smoking by offering structured support. This support includes counseling and follow-up, which are crucial components of the program. Participants in this model have reported success in quitting smoking, suggesting it might be safe to try for quitting vaping as well.

While specific safety data for using NRT to quit vaping is lacking, its approval and use for quitting smoking provide some reassurance about its safety. Researchers will closely monitor trial participants to manage any side effects promptly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ottawa Model for Smoking Cessation (OMSC) because it offers a comprehensive approach to quitting vaping. Unlike standard options that might only provide counseling or nicotine replacement therapy (NRT) separately, OMSC combines both with personalized follow-up support. Participants receive quit cards pre-loaded with funds to purchase NRT, ensuring they have access to necessary resources without financial barriers. The involvement of a trained Nicotine Addiction Treatment Specialist for ongoing support and tailored advice helps optimize NRT use, making it a personalized and structured method for those looking to quit vaping.

What evidence suggests that this trial's treatments could be effective for vaping cessation?

Research has shown that the Ottawa Model for Smoking Cessation (OMSC), which participants in this trial may receive, effectively helps people quit smoking. In past studies, individuals using the OMSC achieved higher success rates than those who did not. For example, one study found an 18.2% quit rate with OMSC, compared to only 4.3% without it. The OMSC combines counseling with nicotine replacement therapy (NRT), which helps control nicotine cravings. Although NRT is not specifically approved for quitting vaping, it is approved for quitting smoking and might help reduce nicotine withdrawal for e-cigarette users. Overall, OMSC has shown promise in aiding nicotine cessation. ^{1 2 6 7 8}

Who Is on the Research Team?

Hassan Mir, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can speak English or French.

You live in Ontario.

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Counselling

Participants complete an initial counselling session to discuss vaping cessation and receive tips to help achieve cessation. They track their smoking/vaping behaviour for 7 days.

1 week

1 visit (in-person)

Randomization and Treatment

Participants are randomly assigned to either the intervention group (counselling and NRT) or the control group (counselling only). Follow-up calls are conducted to support medication titration for the intervention group.

6 months

Follow-up calls at day 3, 7, 14, 21, 30, 60, 90, and 180

Follow-up

Participants are monitored for vaping cessation and continuous abstinence at 1, 3, 6, and 12 months.

12 months

Assessments at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• OMSC

Trial Overview 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.

How Is the Trial Designed?

Group I: Ottawa Model for Smoking Cessation Experimental Treatment 1 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 Care Active Control 1 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.

OMSC is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Nicotine Replacement Therapy for:

• Smoking cessation

Approved in United States as Nicotine Replacement Therapy for:

• Smoking cessation

Approved in Canada as Nicotine Replacement Therapy for:

• Smoking cessation

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

A comprehensive analysis of 8,867,135 reports from the FDA Adverse Event Reporting System revealed that nicotine replacement therapies (NRTs) are associated with several adverse events, including nausea, dizziness, and application site reactions, indicating the need for careful monitoring of their use.

Electronic cigarettes also reported adverse events such as dizziness and increased heart rate, suggesting that while they may be used for smoking cessation, they are not without risks and should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004-2016. Motooka, Y., Matsui, T., Slaton, RM., et al.[2022]

In a study involving 270 participants, the 4-mg nicotine lozenge did not significantly increase biochemically confirmed tobacco abstinence rates compared to placebo (36% vs. 27.6%), but it did show a significant increase in self-reported abstinence rates (44.1% vs. 29.1%).

The nicotine lozenge was effective in reducing nicotine withdrawal symptoms and tobacco cravings over time, indicating its potential as a supportive treatment for smokeless tobacco users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of nicotine lozenge for smokeless tobacco use. Ebbert, JO., Severson, HH., Croghan, IT., et al.[2023]

Combining different nicotine replacement therapies (NRT), such as a transdermal patch for slow nicotine delivery and gum for on-demand relief, may enhance the effectiveness of smoking cessation efforts, potentially providing better withdrawal relief than using a single therapy alone.

While some studies suggest that combination NRT can be more effective than monotherapy for certain individuals, the evidence is not yet strong enough to draw definitive conclusions, indicating a need for further research to fully understand its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability. Sweeney, CT., Fant, RV., Fagerstrom, KO., et al.[2018]

Nicotine replacement therapy, particularly through nicotine patches, significantly increases the chances of quitting smoking, roughly doubling the quit rate compared to placebo, especially when combined with behavioral interventions.

Various nonpharmacologic methods exist to aid smoking cessation, but their effectiveness varies widely, highlighting the importance of tailored approaches based on the individual's stage of smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence. Haxby, DG.[2019]

Most smoking cessation products and programs have not been proven effective, with the exception of nicotine gum and patches used in combination with comprehensive behavioral support.

Multicomponent, behavioral-based group programs are the most successful for helping individuals quit smoking, and physicians should recommend programs that adhere to scientifically accepted standards for measuring success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A physician's guide to smoking cessation. Miller, GH., Golish, JA., Cox, CE.[2005]

Medicinal nicotine has significantly improved smoking cessation rates over the past 20 years, with various products like patches, gum, and inhalers available to help smokers quit.

Innovative nicotine delivery methods, such as high-dose patches and new forms like drinks and lollipops, are being developed to enhance cessation success and manage withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. Shiffman, S., Fant, RV., Buchhalter, AR., et al.[2015]

Nicotine replacement therapies, such as nicotine polacrilex and transdermal patches, are generally safe with very rare major adverse effects, making them a viable option for smoking cessation.

These therapies can double long-term abstinence rates, particularly benefiting highly dependent smokers, and produce lower nicotine levels than cigarettes without harmful tar and carbon monoxide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-benefit assessment of nicotine preparations in smoking cessation. Hughes, JR.[2020]

In a study involving over 6,000 smokers, nicotine replacement therapies (gum and patch) showed higher smoking cessation rates in over-the-counter (OTC) settings compared to prescription (Rx) settings, particularly at 6 weeks.

At 6 weeks, 16.1% of OTC gum users and 19.0% of OTC patch users achieved abstinence, compared to only 7.7% and 16.0% for Rx users, respectively, indicating that self-selection of doses in OTC settings may enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world efficacy of prescription and over-the-counter nicotine replacement therapy. Shiffman, S., Rolf, CN., Hellebusch, SJ., et al.[2022]

In a study of 479 smokers, the nicotine mouth spray demonstrated significantly higher continuous abstinence rates from smoking compared to placebo at weeks 6 (26.1% vs. 16.1%), 24 (15.7% vs. 6.8%), and 52 (13.8% vs. 5.6%), indicating its efficacy in smoking cessation.

While most adverse events were mild to moderate, 9.1% of participants using the active spray withdrew due to side effects, compared to 7.5% in the placebo group, suggesting that while effective, the nicotine mouth spray may have a higher incidence of treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Tønnesen, P., Lauri, H., Perfekt, R., et al.[2021]

Nicotine replacement therapy, such as nicotine polacrilex gum, is most effective when combined with behavioral counseling, although it has shown minimal impact on smoking cessation in general medical practice.

Pharmacotherapeutic options for nicotine dependence include nicotine replacements, antagonists like mecamylamine for difficult cases, and clonidine for reducing withdrawal symptoms, but no single drug is completely effective, highlighting the need for a comprehensive approach that addresses both psychological and physiological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation. Nunn-Thompson, CL., Simon, PA.[2005]

The nicotine mouth spray significantly reduces cravings for cigarettes faster than nicotine lozenges, with users experiencing a 50% reduction in craving within approximately 3.4 minutes, compared to 9.2 and 9.9 minutes for the 2 mg and 4 mg lozenges, respectively.

While both treatments had mostly mild side effects, the mouth spray was associated with more frequent occurrences of hiccups, local irritation, nausea, and dyspepsia compared to the lozenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nicotine mouth spray on urges to smoke, a randomised clinical trial. Hansson, A., Hajek, P., Perfekt, R., et al.[2021]

After the FDA approved over-the-counter (OTC) sales of nicotine replacement therapy (NRT) in 1996, the use of NRT increased by about 60%, indicating greater accessibility for smokers.

However, the effectiveness of the nicotine patch for quitting smoking slightly decreased post-OTC reclassification, with quit rates dropping from 22.5% to 18.5%, while the quit rate for nicotine gum remained stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-counter availability of nicotine replacement therapy and smoking cessation. Hyland, A., Rezaishiraz, H., Giovino, G., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4868562/

Evaluation of the Ottawa Model for Smoking Cessation Implementation of the OMSC was associated with increased rates of smoking cessation treatment delivery. High quality implementation of the OMSC program was ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06164678

Vaping Cessation Using the Ottawa Model for Smoking ... The study hypothesizes that the OMSC approach, which includes the use of nicotine replacement therapy, will result in higher rates of vaping cessation compared ...

3. ottawaheart.ca ottawaheart.ca/patients-visitors/centres-and-programs/ottawa-model-smoking-cessation

Ottawa Model for Smoking Cessation QUALITY: OMSC embodies an efficient, comprehensive, and evidence-based approach to clinical smoking cessation practice and evaluation.

4. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/26/3/293

Effectiveness of a hospital-initiated smoking cessation ... Methods A 2-group effectiveness study was completed comparing patients who received the 'Ottawa Model' for Smoking Cessation intervention (n=726) to usual ...

5. diabetesjournals.org diabetesjournals.org/care/article/41/3/406/36674/Prospective-Cluster-Randomized-Trial-to-Implement

Prospective, Cluster-Randomized Trial to Implement the ... For smokers willing to quit within the next 30 days (n = 135), the quit rate in the OMSC group was 18.2% versus 4.3% in the WLC group (P = 0.023); ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9872945/

Nicotine replacement therapy for vaping cessation among ... This study seeks to 1) to evaluate reasons for quitting e-cigarettes in treatment-seeking adults, and 2) to assess the feasibility and acceptability of nicotine ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/11/2/e044222

Smoking cessation in individuals who use vaping as ... In 2016, a meta-analysis of 20 studies found that people using ENDS had a 28% reduction in the odds of stopping cigarette smoking as compared with those not ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X25000091

Canadian Cardiovascular Society Clinical Practice Update ... The OMSC is a simple, systematic approach for clinicians to: (1) identify the smoking status of all patients; (2) provide brief, practical cessation advice; (3) ...