Quit Card Intervention for Cigarette Addiction

(INITIATE Trial)

Recruiting at 5 trial locations

Overseen By Chantelle Masterson, BPhil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Pregnant, Morbid illness, Acute illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

1208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people quit smoking using a Quit Card Intervention (QCI). It combines behavioral incentives with personalized follow-up support to help smokers quit permanently. The goal is to make quitting easier and more successful, especially for those visiting emergency departments or busy healthcare centers. This trial is ideal for current smokers in Ontario who smoke at least five cigarettes a day and are interested in quitting. Participants must communicate in English or French and have access to a phone or computer for follow-up. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could make quitting smoking more accessible and effective for many.

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 focuses on smoking cessation, so it's best to discuss your medications with the study team or your doctor.

What prior data suggests that the Quit Card Intervention is safe?

A previous study found the Quit Card Intervention (QCI) to be a promising and simple method to assist hospital patients who smoke. The study showed that nicotine replacement therapy (NRT) gift cards, like the Quit Card, were both practical and well-received by patients, indicating ease of use and general satisfaction.

Research indicates that the QCI, which combines support and personalized follow-up, is designed to help people quit smoking more effectively. So far, no major safety concerns have been reported with the Quit Card Intervention, suggesting that participants tolerate the treatment well.

However, detailed information on any unwanted effects specifically linked to the QCI is not available from the sources. While the intervention appears safe, discussing any concerns or questions with the research team or a healthcare provider before joining the trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Quit Card Intervention (QCI) is unique because it offers a behavioral approach to tackling cigarette addiction, unlike traditional methods that often rely on medications like nicotine replacement therapy, bupropion, or varenicline. QCI employs personalized strategies and support to help individuals quit smoking, focusing on changing habits and mindset. Researchers are excited about this method as it could provide a non-pharmacological option that empowers individuals to manage their addiction more effectively, potentially leading to longer-lasting results.

What evidence suggests that the Quit Card Intervention could be effective for cigarette addiction?

Research has shown that personalized programs to help people quit smoking, such as the Quit Card Intervention (QCI) offered in this trial, can succeed, with about 20% of participants quitting. These programs provide customized support and regular check-ins, which are crucial for helping people stop smoking. The QCI combines rewards for good behavior with personalized follow-up, which proved effective in past studies. Offering gift cards for nicotine replacement products also aids by making these treatments more affordable. These methods help overcome obstacles like cost and motivation, increasing the chances of quitting successfully. ^{1 2 3 4 5}

Who Is on the Research Team?

Kerri-Anne Mullen, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for daily smokers aged 18+ in Ontario who smoke at least 5 cigarettes a day, are not critically ill, and can follow up for two years. They must have health insurance, access to phone or computer, understand English or French, and be able to consent.

Inclusion Criteria

Able to provide informed consent

You smoke at least 5 cigarettes every day.

Assigned a CTAS level of 2-5 (emergent to non-urgent)

Exclusion Criteria

I am in critical condition or in a psychiatric emergency.

Has morbid illness which will prevent completion of 26-week follow-up (e.g., receiving palliative care)

Currently participating in this or another smoking cessation study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioural incentive and tailored follow-up support to increase long-term smoking abstinence

26 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for smoking abstinence, health-related quality of life, and healthcare utilization

104 weeks

Follow-up assessments at 4, 26, 52, and 104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quit Card Intervention (QCI)

Trial Overview The INITIATE Study tests a Quit Card Intervention (QCI) designed for emergency department settings. It aims to help smokers quit by combining behavioral incentives with tailored support over time while considering the fast-paced nature of EDs.

How Is the Trial Designed?

Group I: Quit Card Intervention (QCI) Experimental Treatment 1 Intervention

Study intervention group.

Group II: Usual Care (UC) Active Control 1 Intervention

Study control group.

Quit Card Intervention (QCI) is already approved in Canada for the following indications:

Approved in Canada as Not applicable (behavioral intervention) for:

• Smoking cessation support

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The Refer2Quit (R2Q) online training program significantly increased fax referral rates to tobacco quitlines among healthcare providers, with an odds ratio of 2.86, indicating a strong improvement in referral practices after training.

Providers who completed the R2Q training reported enhanced self-efficacy and more positive attitudes towards delivering tobacco cessation interventions, although barriers like lack of reimbursement and patient reluctance still hindered referral rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refer2Quit: impact of Web-based skills training on tobacco interventions and quitline referrals. Carpenter, KM., Carlini, BH., Painter, I., et al.[2012]

In a study of 778 low-income smokers, those who used quitline (QL) services showed higher smoking cessation rates, with 15.3% abstinence in high QL users compared to only 7.2% in non-users.

The findings suggest a positive relationship between the frequency of QL service use and tobacco abstinence, indicating that greater engagement with these services may enhance quit rates among low-income smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Utilization of Quitline Services and Probability of Tobacco Abstinence in Low-Income Smokers. Bernstein, SL., Weiss, JM., Toll, B., et al.[2022]

The Project CLIQ program, which connects low- to moderate-income smokers with cessation resources, was found to be cost-effective, costing about $33 per smoker and $4137 per additional quit over a 20-month period with 707 participants from a pool of 8544 smokers.

The cost-effectiveness of CLIQ improves significantly with higher participation rates and larger populations of smokers, making it a promising strategy for health systems aiming to reduce smoking rates among low-income communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of a Health System-Based Smoking Cessation Program. Levy, DE., Klinger, EV., Linder, JA., et al.[2022]

Varenicline and bupropion are effective smoking cessation aids for patients with cardiovascular disease, showing significantly higher abstinence rates compared to placebo in a meta-analysis of 7 pharmacotherapy trials involving 2809 participants.

Behavioral interventions, particularly individual counseling and telephone therapy, also demonstrate efficacy in promoting smoking cessation among CVD patients, outperforming usual care in a review of 17 trials with 4666 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Smoking Cessation Interventions in Patients With Cardiovascular Disease: A Network Meta-Analysis of Randomized Controlled Trials. Suissa, K., Larivière, J., Eisenberg, MJ., et al.[2018]

A survey of 14 tobacco quitline service providers across all 50 US states revealed that while all recommended setting a new quit date for smokers who missed their target quit date, only 6% used motivational interviewing techniques to encourage this.

The majority of quitlines (90%) focused on interventions aimed at reducing smoking rates rather than directly promoting complete cessation, indicating a need for further research to assess the effectiveness of these reduction strategies in improving overall smoking abstinence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of smoking reduction strategies among U.S. tobacco quitlines. Asfar, T., Ebbert, JO., Klesges, RC., et al.[2018]

Clinicians can significantly reduce cardiovascular risks by actively helping patients quit smoking, which includes documenting smoking status and providing strong advice to quit at every visit.

Effective pharmacotherapies like nicotine replacement, bupropion, and varenicline can double the chances of quitting, but comprehensive support such as behavioral counseling and follow-up is often lacking, highlighting the need for referrals to specialized quitlines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing smoking cessation in clinical practice: pharmacologic and behavioral interventions. Nides, M., Leischow, S., Sarna, L., et al.[2023]

Quitting smoking significantly lowers the risk of cardiovascular events, and most patients with cardiovascular disease (CVD) want to stop smoking, making effective interventions crucial.

Combining behavioral counseling with pharmacologic treatments, like nicotine patches and bupropion, can greatly enhance long-term cessation rates in CVD patients, and creating supportive clinical environments can further improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Smoking in Patients with Cardiovascular Disease. Joseph, AM., An, LC.[2022]

The University of Ottawa Heart Institute implemented a comprehensive program that successfully identified and treated nearly 1300 smokers during their hospitalization for coronary artery disease, with 91% receiving cessation interventions.

Six months after hospitalization, 44% of participants were smoke-free, demonstrating that hospital stays can be a critical time to encourage smoking cessation when patients are most motivated to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting smoking cessation during hospitalization for coronary artery disease. Reid, RD., Pipe, AL., Quinlan, B.[2022]

An empathic and personalized smoking cessation intervention program, with extended assistance and follow-up, is the most effective way to prevent serious health issues like heart disease and cancer in tobacco users, aiming for complete cessation rather than just reduction.

Current guidelines for smoking cessation, based on the Transtheoretical Model and the 'Five A's' (Ask, Advise, Assess, Assist, Arrange), provide a structured approach for clinicians, but these interventions are often underutilized due to a lack of training and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. Anczak, JD., Nogler, RA.[2022]

In a study involving 8144 participants, varenicline and bupropion were associated with specific adverse events (AEs) like nausea and insomnia compared to the nicotine patch, but overall, these treatments were well tolerated with less than 1.5% of participants experiencing severe AEs.

Most reported AEs were manageable and not clinically significant, allowing healthcare providers to reassure patients about the safety of these smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Ebbert, J., Jimenez-Ruiz, C., Dutro, MP., et al.[2021]

The TIME-TQ intervention, developed for smokers in substance use disorder treatment, received positive feedback and significantly increased participants' readiness to quit smoking and their perceived importance of quitting.

Despite the initial motivation to quit, the standard referral method to quitline services was ineffective, as only three participants received counseling and none achieved sustained abstinence, highlighting the need for improved referral strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary pilot evaluation of a brief tablet computer intervention to motivate tobacco quitline use among smokers in substance use treatment. Brown, RA., Hecht, J., Bloom, EL., et al.[2018]

An intensive smoking cessation intervention for cardiac patients, involving bedside counseling and follow-up calls, resulted in a 62% abstinence rate at 12 months, compared to 46% in a minimal intervention group, indicating that more comprehensive support significantly improves quitting success.

Patients who underwent coronary artery bypass grafting (CABG) had higher rates of continuous abstinence (57%) compared to those admitted for acute myocardial infarction (39%), suggesting that the type of cardiac event may influence the effectiveness of smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation initiated during hospital stay for patients with coronary artery disease: a randomized controlled trial. Smith, PM., Burgess, E.[2022]

The study found that an intensive intervention (II) combining brief advice, motivational interviews, and nicotine replacement therapy (NRT) led to a higher self-reported quit rate of 19.5% compared to 11.4% for the brief intervention (BI) alone, indicating that more comprehensive support can improve smoking cessation outcomes.

Despite the effectiveness of the II, there were significant challenges in its implementation, particularly in delivering motivational interviews and prescribing NRT, highlighting the need for practical strategies to enhance smoking cessation programs in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation interventions in the pre-admission clinic: assessing two approaches. Sachs, R., Wild, TC., Thomas, L., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8541807/

The INITIATE trial protocol: a randomized controlled ... An equal number of quit kits will be prepared for each CTAS level. The primary outcome will be bio-chemically verified smoking abstinence at 26 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34688291/

The INITIATE trial protocol: a randomized controlled ... It is hypothesized that the QCI group will have higher a abstinence rate, improved health outcomes, and decreased healthcare utilization.

3. withpower.com withpower.com/trial/quit-card-intervention-for-cigarette-addiction-1a524

Quit Card Intervention for Cigarette Addiction (INITIATE Trial) Research shows that personalized smoking cessation programs with extended support and follow-up can be effective, with quit rates approaching 20%. Additionally, ...

4. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/32/5/546

Nicotine replacement therapy 'gift cards' for hospital inpatients ... Conclusions The NRT gift card appears to be a feasible and effective smoking cessation tool that removes a primary barrier to the use of evidence-based smoking ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837640

Just-in-Time Adaptive Intervention for Smoking Cessation ... Meaning These findings suggest that personalized, real-time digital interventions may improve smoking cessation among low-income populations, ...