Conversational Agents for Opioid Use Disorder

(SARA RCT Trial)

Overseen By Samantha Blakemore, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Buprenorphine

Disqualifiers: Incarceration, Comprehension issues, ECA app use

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual assistant, known as an Embodied Conversational Agent (ECA), to help individuals adhere to their buprenorphine treatment for opioid use disorder. The ECA functions like a chatty app on a smartphone, aiming to support recovery by engaging users in conversation. Suitable candidates for this trial have been diagnosed with opioid use disorder, are currently taking buprenorphine, and own a smartphone. Participants will either use the ECA app with additional support or continue their usual treatment routine. As an unphased trial, this study provides a unique opportunity to explore innovative support tools for recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on supporting patients already on buprenorphine treatment for opioid use disorder.

What prior data suggests that this Embodied Conversational Agent is safe for opioid use disorder treatment?

A previous study showed that Embodied Conversational Agents (ECAs) encourage healthier behaviors. ECAs are virtual helpers that interact like a person. They have been used in various healthcare settings without reports of serious safety concerns. Although detailed safety data for ECAs in opioid use disorder treatment is not yet available, their use in other areas suggests general safety. The current trial employs an ECA to assist individuals in continuing their buprenorphine treatment for opioid use disorder. While specific safety outcomes are not yet available, the use of ECAs in similar settings has not raised significant safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Embodied Conversational Agents (ECA) for opioid use disorder because this approach leverages technology to provide continuous, personalized support. Unlike traditional treatments, which often rely on in-person therapy and medication, ECAs offer a digital interaction that can be accessed anytime, helping to bridge gaps in care. The ECA not only delivers reminders and encouragement but also engages users in a dynamic way, potentially increasing adherence to treatment plans through interactive and tailored communication. This innovative use of technology could significantly enhance accessibility and patient engagement, offering a promising new tool in the fight against opioid use disorder.

What evidence suggests that the Embodied Conversational Agent is effective for opioid use disorder?

Research shows that virtual helpers, known as Embodied Conversational Agents (ECAs), can be useful in healthcare. Studies have found these virtual agents easy to use and generally liked by people. They have been linked to positive changes in attitudes and behaviors related to substance use. Evidence indicates that ECAs can boost confidence and reduce cravings for those dealing with substance issues. In this trial, participants in the intervention arm will engage with ECAs, receive technical support, additional ECA messages, and incentives. These early findings suggest that ECAs might help people stay committed to their treatment for opioid use disorder. ^{1 2 4 5 6}

Who Is on the Research Team?

Karsten Lunze, MD MPH DrPH

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals receiving buprenorphine treatment for opioid use disorder. Participants should be comfortable using a smartphone and engaging with a virtual agent designed to support their recovery process.

Inclusion Criteria

Possession of a smartphone that has minimum requirements

English-speaking

Willing to release electronic health record (EHR) data

Exclusion Criteria

I haven't taken sublingual buprenorphine in the last 30 days or had a long-acting injectable form in the last 56 days, except for short-term use.

I understand the study details after being explained up to three times.

Incarceration anticipated within 12 months of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive buprenorphine treatment with the support of an Embodied Conversational Agent (ECA) intervention or treatment as usual

12 months

Regular virtual interactions with the ECA app

Follow-up

Participants are monitored for treatment retention and changes in opioid use, stigma, recovery capital, and user satisfaction

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Embodied Conversational Agent (ECA)

Trial Overview The study tests if an Embodied Conversational Agent (ECA) on smartphones helps people stay in buprenorphine treatment longer. It compares the effectiveness of additional ECA messages and incentives versus standard technical support.

How Is the Trial Designed?

Group I: ECA, technical support, additional ECA messages, and incentives Experimental Treatment 4 Interventions

Participants randomized into the intervention arm will be engaged in ECA use, technical support, additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff, and monetary incentives.

Group II: Treatment as usual group Active Control 1 Intervention

Participants randomized into this arm will receive treatment as usual

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The study assessed the feasibility and acceptability of an Embodied Conversational Agent (ECA) designed to support smoking cessation among veterans, with 6 participants using the program over 14 days.

All participants found the ECA-Q program satisfactory, and half of them set a quit date by the end of the study, indicating that this virtual coaching approach could be a helpful tool for motivating smokers to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Tablet Based Embodied Conversational Agent to Promote Smoking Cessation among Veterans: A Feasibility Study. Abdullah, AS., Gaehde, S., Bickmore, T.[2020]

Citations

1. withpower.com withpower.com/trial/phase-opioid-related-disorders-2025-fe40c

Conversational Agents for Opioid Use Disorder ... This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10746972/

Embodied Conversational Agents Providing Motivational ... Overall, the studies reported positive results regarding acceptability, usability, and user experience and showed promising outcomes in changes in attitudes, ...

3. researchgate.net researchgate.net/publication/348926318_Outcomes_of_an_Automated_Conversational_Agent_for_Reducing_Problematic_Substance_Use_Development_Usability_Study_Preprint

Development & Usability Study (Preprint) | Request PDF Conclusions W-SUDs was feasible to deliver, engaging, and acceptable and was associated with significant improvements in substance use, confidence, cravings, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748923000597

Feasibility and effectiveness of artificial intelligence-driven ... Our review findings indicated that conversational agent-based interventions were feasible, acceptable, and had positive effects on physical functioning, healthy ...

5. bu.trialstoday.org bu.trialstoday.org/trial/NCT06732596

Boston University - Clinical & Translational Science Institute This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone- ...

6. meddatax.com meddatax.com/clinical-trials/NCT06732596

Sustaining Recovery for People on Opioid Agonist Treatment ... The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates. Basic ...