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

Trial Summary

What is the purpose of this trial?

This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention. The intervention involves an Embodied Conversational Agent (ECA), a virtual, animated computer agent designed to simulate natural face-to-face conversations. ECAs have been shown to help individuals manage their healthcare in other settings, and this study seeks to evaluate their potential in supporting patients on medication for opioid use disorder (MOUD).

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 data supports the effectiveness of the treatment Embodied Conversational Agent (ECA) for opioid use disorder?

Research shows that similar digital therapies, like the relational agent Woebot, have helped reduce substance use in adults. Additionally, ECAs have been found acceptable and useful in helping people quit smoking, suggesting they could be effective for opioid use disorder as well. ^{1 2 3 4 5}

Is the use of conversational agents for opioid use disorder safe?

The research on digital therapeutics, including conversational agents, for opioid use disorder suggests they are generally safe for use in humans, as they have been evaluated in clinical trials without significant safety concerns reported. ^{1 2 3 4 6}

How is the Embodied Conversational Agent (ECA) treatment different from other treatments for opioid use disorder?

The Embodied Conversational Agent (ECA) is unique because it uses a virtual, interactive agent to provide therapy, which can be accessed remotely and at home, unlike traditional face-to-face treatments. This approach can improve accessibility and engagement for individuals who may face barriers to in-person therapy. ^{1 2 3 5 7}

Research Team

Karsten Lunze, MD MPH DrPH

Principal Investigator

Boston Medical Center

Eligibility Criteria

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.

Incarceration anticipated within 12 months of enrollment

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Group 3- ECA, technical support, additional ECA messages, and incentives Experimental Treatment 4 Interventions

Participants randomized into this arm will be engaged in ECA use and additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff with added incentives

Group II: Group 2- ECA, technical support, and additional ECA messages Experimental Treatment 3 Interventions

Participants randomized into this arm will be engaged in ECA use and additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff

Group III: Group 1- ECA and technical support Experimental Treatment 2 Interventions

Participants randomized into this arm will be engaged in ECA use and technical support only

Group IV: 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+

Findings from Research

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]

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]

References

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

Virtual Digital Psychotherapist App-Based Treatment in Patients With Methamphetamine Use Disorder (Echo-APP): Single-Arm Pilot Feasibility and Efficacy Study. [2023]

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

A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Development and validation of a virtual agent to screen tobacco and alcohol use disorders. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Tablet Based Embodied Conversational Agent to Promote Smoking Cessation among Veterans: A Feasibility Study. [2020]

6. Netherlands 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. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Conversational Agents in the Treatment of Mental Health Problems: Mixed-Method Systematic Review. [2020]