Healthbot Support for Medication Adherence

Overseen By Nadia Minian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: Varenicline

Disqualifiers: Pregnancy, Breastfeeding, Varenicline contraindications, 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: 6

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a healthbot designed to help people adhere to their varenicline medication, used for quitting smoking. The researchers aim to identify challenges people face when taking varenicline and how a healthbot can help overcome these. Participants will interact with the healthbot, which provides reminders, advice on side effects, and answers to medication questions. The trial seeks daily smokers in Ontario who want to quit and are willing to take varenicline for 12 weeks. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially enhance smoking cessation support for others.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be willing to start taking varenicline for 12 weeks.

What prior data suggests that this healthbot is safe for improving medication adherence?

Research has shown that varenicline, a medication to help people quit smoking, is usually well-tolerated. Most study participants do not experience serious side effects. However, some report nausea or trouble sleeping. The FDA has noted rare issues such as seizures or problems when mixed with alcohol. While uncommon, these are important to know. If varenicline is recommended, a doctor can help manage any side effects. This trial tests a healthbot designed to remind people to take their varenicline, potentially making it easier to adhere to the schedule and reduce these issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for medication adherence, which often rely solely on patient self-management or periodic check-ins, the varenicline healthbot offers a more integrated approach. This healthbot provides real-time reminders for varenicline dosing, offers strategies for managing side effects, and answers common questions about medication use. Researchers are particularly excited about the healthbot's ability to boost motivation and maintain engagement during quit attempts, potentially leading to higher adherence rates and better outcomes for those trying to quit smoking.

What evidence suggests that this healthbot is effective for improving varenicline adherence?

Research shows that varenicline helps people quit smoking. Studies indicate that when taken correctly, varenicline can lead many to stop smoking. In this trial, participants will use a healthbot designed to send reminders and support, making it easier to take varenicline as directed. Previous patients demonstrated that adhering to the medication schedule can improve quitting rates. Additionally, addressing side effects and boosting motivation through the healthbot may enhance varenicline's effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Nadia Minian, PhD

Principal Investigator

CAMH

Are You a Good Fit for This Trial?

This trial is for treatment-seeking smokers over 18 in Ontario who smoke 10+ cigarettes daily, are ready to start and stick with varenicline for 12 weeks, set a quit date soon, speak English, have a smartphone with data, and commit to follow-ups. It's not for those with varenicline contraindications or pregnant/breastfeeding women.

Inclusion Criteria

Smoke cigarettes daily (10 or more cigarettes a day)

Speak/read English

Have a smartphone with data plan

Exclusion Criteria

I cannot use varenicline due to health reasons.

Are pregnant/planning to become pregnant/breastfeeding

Participated in the co-design phase

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Discover Phase

Literature review and interviews with service users and healthcare providers to identify challenges and strategies for varenicline adherence

4 weeks

Design, Build and Test Phase

Participants interact with a preliminary healthbot using the Wizard of Oz method and provide feedback

4 weeks

1 visit (virtual)

Feasibility Study

Participants interact with the healthbot for 12 weeks to assess usability, appropriateness, adoption, acceptability, and fidelity

12 weeks

4 visits (virtual or in-person) at 1, 4, 8, and 12 weeks

Follow-up

Participants are monitored for smoking cessation and medication adherence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Varenicline healthbot

Trial Overview The study tests a healthbot designed to help people stick to their varenicline regimen. Participants will use the healthbot over 12 weeks while researchers measure its effectiveness on medication adherence and smoking cessation using interviews and feedback.

How Is the Trial Designed?

Group I: Varenicline healthbot Experimental Treatment 1 Intervention

While the exact healthbot features will be based on results from the rapid review, interviews and Wizard of OZ testing, the investigators know from the existing literature on medication adherence, and behaviour change interventions, that the healthbot will provide: 1) reminders for varenicline dosing and schedule; 2) information and suggestions on managing known side effects (the most frequently cited reason for varenicline non-adherence is experiencing side effects); 3) answers to questions about medication use (e.g., what to do if a dose is missed); and 4) support to increase participants' motivation to continue their quit attempts. During the next 12 weeks, participants will be reminded by the healthbot to take their varenicline at the appropriate times, and will be able to interact with the healthbot when they want.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Published Research Related to This Trial

In a study of 2,682 patients using varenicline for smoking cessation, nausea and vomiting were the most common reasons for discontinuation and the most frequently reported adverse drug reactions, highlighting the need for patient monitoring regarding gastrointestinal side effects.

While some psychiatric events were reported, including anxiety and depression, all cases of suicidal behavior involved patients with prior psychiatric conditions, suggesting that clinicians should closely monitor individuals with such histories when prescribing varenicline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Kasliwal, R., Wilton, LV., Shakir, SA.[2021]

The study aims to test 'ChatV', an AI health bot designed to improve adherence to varenicline, a medication for smoking cessation, by providing reminders and support to users during a 12-week treatment period with 40 participants.

The feasibility study will assess how well participants use ChatV and its impact on medication adherence and smoking cessation, with results guiding the decision to proceed to a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study. Minian, N., Mehra, K., Earle, M., et al.[2023]

Varenicline is recognized as the most effective medication for smoking cessation, and adherence to this medication is crucial for successful quitting, highlighting its importance in reducing tobacco-related health issues.

The study aims to develop a patient-centered healthbot to improve adherence to varenicline by utilizing a structured approach that includes patient and healthcare provider input, ensuring the healthbot is informed by behavioral science and real-world needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cocreation of a conversational agent to help patients adhere to their varenicline treatment: A study protocol. Minian, N., Mehra, K., Rose, J., et al.[2023]

Chantix (varenicline tartrate) was approved by the FDA in May 2006 as a smoking cessation aid for adults aged 18 and older.

The approval indicates that Chantix is considered a safe and effective option to help smokers quit, although the abstract does not provide specific efficacy data or study details.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The FDA approves new drug for smoking cessation. [2015]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

In a real-world study involving 566 participants across four European countries, varenicline was found to be an effective smoking cessation aid, with a 64.6% quit rate by the end of the 12-week treatment period.

The safety profile of varenicline was acceptable, with the most common side effects being mild to moderate nausea (8.9%) and insomnia (2.9%), and only 3.4% of participants discontinued due to treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. Boudrez, H., Gratziou, C., Messig, M., et al.[2015]

In a pilot study of 72 Black smokers, varenicline showed adequate adherence rates (86.1%) and led to a significant reduction in smoking (12.2 cigarettes per day), but only 23.6% achieved confirmed quit status at 3 months.

Higher adherence to varenicline was associated with successful quitting, suggesting that improving adherence to smoking cessation medications could enhance abstinence rates among Black smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot clinical trial of varenicline for smoking cessation in black smokers. Nollen, NL., Cox, LS., Nazir, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4824380/

Varenicline for smoking cessation: a narrative review of ... The effectiveness of varenicline can be improved by taking it in combination with other medications, enhancing patient adherence and extending the duration of ...

2. pfizer.com pfizer.com/news/press-release/press-release-detail/chantix_champix_varenicline_demonstrates_smoking_cessation_efficacy_in_smokers_unwilling_or_unable_to_quit_abruptly

CHANTIX®/CHAMPIX® (varenicline) Demonstrates Smoking A new smoking-cessation clinical study assessing the efficacy and safety of varenicline (CHANTIX®/CHAMPIX®) met its primary and secondary endpoints.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05997901

Helping People Adhere to Their Varenicline Treatment by ... Does a healthbot developed to improve varenicline adherence meet the implementation outcomes and increase medication adherence as well as smoking cessation? The ...

4. researchprotocols.org researchprotocols.org/2023/1/e53556/

AI Conversational Agent to Improve Varenicline Adherence ChatV is an evidence-based, patient- and health care provider–informed health bot to improve adherence to varenicline.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3082504/

Adherence to Varenicline in the COMPASS Smoking ... Abstinence rates in this real-world effectiveness study were high (31%–34%) and similar to rates seen in varenicline clinical trials when the medication was ...

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-updates-label-stop-smoking-drug-chantix-varenicline-include

FDA updates label for stop smoking drug Chantix FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/varenicline-oral-route/description/drg-20068324

Varenicline (oral route) - Side effects & dosage Varenicline is used together with a support program to help you stop smoking. The program will include counseling and educational materials.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534846/

Varenicline - StatPearls - NCBI Bookshelf - NIH Varenicline is a medication prescribed to help patients stop smoking, targeting one of the most modifiable risk factors for preventing human disease.

9. webmd.com webmd.com/drugs/2/drug-144470/chantix-oral/details

Varenicline (Chantix) - Uses, Side Effects, and More Varenicline is commonly used to help people quit smoking. Varenicline may also be used for other conditions as determined by your healthcare provider.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2962400/

Varenicline for smoking cessation: efficacy, safety, and ... Varenicline is efficacious and cost-effective. Smoking relapse and adverse treatment-related side effects may decrease medication adherence and patient ...