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

Trial Summary

What is the purpose of this trial?

The goal of this feasibility study is to co-create and evaluate a theory informed, evidence-based, patient-centered healthbot aimed at helping people adhere to their varenicline regimen. The main research questions it aims to answer are: 1. What are the challenges to varenicline adherence and strategies to overcome such challenges from the perspective of service users and service providers? 2. What features of a healthbot would help improve adherence to varenicline? 3. Does a healthbot developed to improve varenicline adherence meet the implementation outcomes and increase medication adherence as well as smoking cessation? The study will be conducted using the Discover Design Build and Test framework. * In the Discover phase, a literature review, 20 service user interviews, and 20 healthcare provider interviews will help inform the challenges to varenicline adherence, strategies to overcome them using the Capability, Opportunity, Motivation, and Behavior framework, and the ways in which a healthbot might help improve adherence. * In the Design, Build and Test phase, 40 participants will interact with a preliminary healthbot using the Wizard of Oz method, then provide feedback about their experiences in a follow up interview; and team members, including clinicians and researchers, will beta test and validate a more refined healthbot. In the last phase, a non-randomized single arm feasibility study, 40 participants will interact with the healthbot for 12 weeks and provide feedback about the acceptability, appropriateness, fidelity, adoption, and usability of the healthbot; and researchers will assess participants' medication adherence and smoking status.

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 data supports the effectiveness of the drug varenicline for medication adherence?

Varenicline is a proven and effective medication for helping people quit smoking, and sticking to the medication increases the chances of successfully quitting. Healthbots, like the AI conversational agent ChatV, are designed to help people remember to take their medication and provide support, which can improve adherence to varenicline. ^{1 2 3 4 5}

Is the Healthbot Support for Medication Adherence treatment safe for humans?

Varenicline, used in the Healthbot Support for Medication Adherence, has been associated with some psychiatric side effects like depression and suicidal thoughts, but it generally has an acceptable safety profile for helping people quit smoking. ^{3 4 5 6 7}

How does the Healthbot Support for Medication Adherence treatment differ from other treatments for smoking cessation?

The Healthbot Support for Medication Adherence is unique because it uses an AI conversational agent, ChatV, to help people stick to their varenicline medication schedule. This health bot provides reminders, answers questions, and tracks medication use, which is different from traditional methods that don't typically include interactive, real-time support. ^{1 2 3 4 5}

Research Team

Nadia Minian, PhD

Principal Investigator

CAMH

Eligibility Criteria

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

I am a smoker ready to quit using varenicline for 12 weeks and will set a quit date within 30 days.

Smoke cigarettes daily (10 or more cigarettes a day)

I am 18 years old or older.

Exclusion Criteria

I cannot use varenicline due to health reasons.

Are pregnant/planning to become pregnant/breastfeeding

Participated in the co-design phase

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A pilot clinical trial of varenicline for smoking cessation in black smokers. [2022]

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

Cocreation of a conversational agent to help patients adhere to their varenicline treatment: A study protocol. [2023]

4. New Zealand 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. [2021]

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

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. [2015]

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

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