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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for smoking cessation?

Research shows that using nicotine replacement therapies like patches, gum, lozenges, inhalers, and mouth sprays can help people quit smoking by providing a steady supply of nicotine to reduce cravings and withdrawal symptoms. Combining different forms of these therapies, such as a patch with a faster-acting option like gum or a mouth spray, can be more effective than using just one type alone. ^{1 2 3 4 5}

Is nicotine replacement therapy safe for humans?

Nicotine replacement therapies like patches, gum, and lozenges are generally safe for humans, with major adverse effects being very rare. They produce lower nicotine levels than cigarettes and do not contain harmful substances like tar and carbon monoxide. ^{1 6 7 8 9}

How is the OMSC treatment for vaping cessation different from other treatments?

The OMSC treatment is unique because it combines multiple forms of nicotine replacement therapies, such as gum, patches, lozenges, inhalers, and mouth sprays, to help people quit vaping. This approach offers flexibility in administration routes and can be tailored to individual preferences, potentially increasing the chances of successful cessation compared to using a single form of nicotine replacement. ^{1 8 10 11 12}

Research Team

Hassan Mir, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. [2015]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effects of nicotine mouth spray on urges to smoke, a randomised clinical trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Over-the-counter availability of nicotine replacement therapy and smoking cessation. [2017]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of nicotine lozenge for smokeless tobacco use. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation. [2005]

9. New Zealand pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A physician's guide to smoking cessation. [2005]

12. England pubmed.ncbi.nlm.nih.gov

Real-world efficacy of prescription and over-the-counter nicotine replacement therapy. [2022]