Health TrialsbyHealthPanel

Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents

ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Opioid Use Disorder (OUD)

Within 30 days of intake at recruitment site (BMC OBAT)

Possession of a smartphone that has minimum requirements

English-speaking and reading

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Embodied conversational agent (ECA)

    Other intervention

    The app with the ECA will be provided.

  • Technical support

    Other intervention

    Technical support will include assistance downloading and setting up the app on the participant's phone, walking them through a brief demonstration, and answering any questions the participant has about how to use the app.

  • Additional ECA messages

    Other intervention

    Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff.

  • Additional incentives

    Other intervention

    Additional incentives will be provided after logging into the app for 20 days followed by monthly lotteries for those who log in 15 days per month

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ECA, technical support, additional ECA messages, and incentivesExperimental treatment 4 interventions
Group B: Treatment as usual groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants that stay engaged in buprenorphine treatment

Engaged in buprenorphine treatment or treatment retention is defined as a participant's treatment period of at least 365 days, including those with multiple disengagement and reengagement periods, as long as any gap in active prescriptions or receipt of injections is less than 60 days.

Time frame
12 months

Secondary outcomes

1

Treatment retention at 6 months

Treatment retention is defined as a participant's treatment period of at least 365 days, including those with multiple disengagement and reengagement periods, as long as any gap in active prescriptions or receipt of injections is less than 60 days.

Time frame
6 months
2

Treatment duration

Treatment duration is defined as length of continuous buprenorphine treatment in days until first discontinuation and will be measured via electronic health record (EHR) prescription and injection data and supplemented with self-report. Discontinued buprenorphine treatment occurs once the EHR indicates that they haven't filled a buprenorphine prescription or haven't received a buprenorphine injection in the previous 60 days. The treatment discontinuation date will be the last day of an active prescription or injection received.

Time frame
6 months. 12 months
3

Opioid use

Opioid use will be measured by self-report via the modified Addiction Severity Index (ASI). The modified ASI is administered by the study staff for a list of 20 drugs/substances. For each the number of days of use and the route of administration of that drug/substance \[0=N/A, 1=oral, 2=nasal, 3=smoking, 4=non-intravenous (IV), injection 5=IV, or 8=refused\] is documented.

Time frame
6 months
4

Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)

The SU-SMS is a self reported, 18-item instrument. Each item has a 5 Likert frequency responses from 1=Never to 5=Very often. Total scores can range from 1 to 90 or from 1-30 for each of the three types of stigma \[anticipated, enacted, and internalized\]. Lower scores are correlated with less stigma.

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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