Healthbot Support for Medication Adherence

Recruiting in Palo Alto (17 mi)

Overseen by Nadia Minian, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre for Addiction and Mental Health

Must be taking: Varenicline

Disqualifiers: Pregnancy, Breastfeeding, Varenicline contraindications, others

No Placebo Group

Approved in 3 Jurisdictions

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre for Addiction and Mental Health Toronto, Canada

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health Lead Sponsor

Canadian Institutes of Health Research (CIHR) Collaborator

Canadian Cancer Society (CCS) Collaborator

References

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

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study. [2023] Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called "ChatV," based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider-informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes.

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

A pilot clinical trial of varenicline for smoking cessation in black smokers. [2022] Varenicline, a first-line non-nicotine medication, has not been evaluated in Black smokers, and limited attention has been paid to pharmacotherapy adherence in smoking cessation trials. This pilot study estimated quit rates for Black smokers treated with varenicline and tested a behavioral intervention to aid varenicline adherence.

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] Varenicline is the most efficacious approved smoking cessation medication, making it one of the most cost-effective clinical interventions for reducing tobacco-related morbidity and mortality. Adhering to varenicline is strongly associated with smoking cessation. Healthbots have the potential to help people adhere to their medications by scaling up evidence-based behavioral interventions. In this protocol, we outline how we will follow the UK's Medical Research Council's guidance to codesign a theory-informed, evidence-based, and patient-centered healthbot to help people adhere to varenicline.

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] Varenicline tartrate (Champix), a new smoking cessation medicine, was launched in the UK in December 2006. Varenicline is a highly selective partial agonist of the alpha(4)beta(2) nicotinic acetylcholine receptor (alpha(4)beta(2) receptor). The partial agonistic binding leads to alleviation of symptoms of craving and withdrawal, and simultaneously prevents nicotine from binding to the alpha(4)beta(2) receptor thereby causing reduction in the rewarding and reinforcing effects of smoking. Regulatory concerns have arisen about psychiatric events associated with varenicline, including depression, suicidal ideation and changes in behaviour/emotion.

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

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021] Varenicline (Champix(®)), launched in the UK in December 2006, is indicated for the treatment of smoking cessation in adults (≥18 years of age). In 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK issued a warning suggesting that varenicline was associated with disparate neuropsychiatric symptoms, including depression, suicidal thoughts and behaviour. In response to this regulatory warning, the Drug Safety Research Unit conducted a modified prescription-event monitoring (M-PEM) study to monitor the safety of varenicline.

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

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. [2015] Varenicline tartrate, a selective partial agonist of the α4β2 nicotinic receptor, has been shown to be an effective smoking cessation aid with an acceptable safety profile in a number of randomized, controlled trials. The aim of the CHOICES (Champix Observational Investigation in the Cessation of Smoking) study was to investigate the effectiveness and safety of varenicline in real-world clinical practice.

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

The FDA approves new drug for smoking cessation. [2015] In May 2006, the Food and Drug Administration approved Chantix (varenicline tartrate) tablets to help cigarette smokers ages 18 and older stop smoking.