Clinical trial NCT06732596: Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents
Official title: Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Embodied conversational agent (ECA)
Buprenorphine treatment
Medication for opioid use disorder (MOUD)
Office Based Addiction Treatment
Supportive Application for Recovery Assistance (SARA)
Smartphone delivered intervention
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups: 75 will receive the ECA intervention in addition to usual care, while 25 will receive only usual care. The ECA group will be further divided into three subgroups based on different engagement strategies.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: One hundred participants will be enrolled in the study from the Office-Based Addiction Treatment (OBAT) clinic at Boston Medical Center (BMC). The participants will be randomly assigned to one of two groups: 75 will receive the ECA intervention in addition to usual care, while 25 will receive treatment as usual. The ECA group will be further divided into three subgroups based on different engagement strategies: 1) technical support only, 2) technical support with additional messages from the ECA on behalf of OBAT clinic staff, and 3) the same as group 2, but with incentives if they log into the app for 15 days that month. The primary outcome is retention in buprenorphine treatment over 12 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Opioid Use Disorder (OUD)
* Within 14 days of intake at recruitment site (BMC OBAT) and 30 days of current buprenorphine treatment episode
* Possession of a smartphone that has minimum requirements
* English-speaking
* Willing to release electronic health record (EHR) data
* Able to provide at least two alternate contacts who usually know how to get in touch with them
* Able to provide informed consent and participate in this study

Exclusion Criteria:

* Treatment with sublingual buprenorphine in the 30 days prior to current treatment episode (56 days for long acting injectable buprenorphine), excluding bridge prescriptions of less than three days
* Incarceration anticipated within 12 months of enrollment
* Inability to comprehend the study protocol, defined as failing three times to answer correctly a set of questions during the consent process
* Inability to use the ECA app (i.e., due to markedly limited visual or auditory acuity or motor function required to interact with the ECA)

Primary outcomes:
measure: Number of participants that stay engaged in buprenorphine treatment
timeFrame: 12 months
Secondary outcomes:
measure: Treatment retention at 6 months
timeFrame: 6 months
measure: Treatment duration
timeFrame: 6 months. 12 months
measure: Opioid use
timeFrame: 6 months
measure: Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)
timeFrame: Baseline, 6 months
measure: Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)
timeFrame: Baseline, 6 months
measure: Changes in recovery capital
timeFrame: Baseline, 6 months
measure: Frequency of interaction with the ECA app
timeFrame: 6 months, 12 months
measure: User attitude and satisfaction toward the ECA
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Office-Based Addiction Treatment (OBAT) Clinic, BMC
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Karsten Lunze, MD MPH DrPH
role: PRINCIPAL_INVESTIGATOR
References: