CClinicalTrials.gg
TerminatedNCT06569667Updated Sep 8, 2026

Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids

An interventional study of PRC supported text + AI driven SDH-enhanced text and AI driven SDH-enhanced text only in Opioid Use Disorder, sponsored by Friends Research Institute, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Friends Research Institute, Inc. · Not applicable, Interventional, and Health services research

Why this study was terminated
Loss of sponsor funding
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Black and Latinx people who use opioids are disproportionately impacted by opioid overdose deaths. The proposed study assesses the efficacy of an open source, multimodal artificial intelligence-driven texting tool combined with peer recovery coach-supported text contact that delivers social services, stigma reduction, health habitus, and patient navigation content addressing social determinants of health to enhance receipt of buprenorphine in primary care among emergency department-enrolled Black / Latinx people who use opioids.

Read the detailed description

The investigators have validated a theory-driven, artificial intelligence (AI)-driven texting tool using natural language processing to facilitate real-time text responses to patient queries combined with automated texts facilitating receipt of buprenorphine in office-based opioid treatment (OBOT) and social services that address social determinants of health (SDH). This open-source texting tool offers passive reminders, informational content, and interactive two-way response algorithms without personal staff contact. In addition, the investigators have adapted an efficacious cultural and structural humility training for PRCs that goes beyond SDH to also address stigma reduction, discrimination, health habitus, and patient navigation to enhance uptake of primary care and social services for PWUO.

Using a three-arm, comparative effectiveness trial design, the specific aims are to: (1) Assess the efficacy of PRC supported text-based care/services coordination with PWUO + AI-driven SDH-enhanced text messaging (intervention arm-1) vs. AI-driven SDH-enhanced text messaging only (intervention arm-2) vs. Treatment as Usual (TAU) or printed social/medical services referrals (control) to enhance the receipt of buprenorphine in OBOT among community and ED-enrolled Black / Latinx PWUO (N=252); (2) Evaluate the implementation of the multimodal intervention (arm-1) guided by the RE-AIM and CFIR frameworks using in-depth interviews among 3 stakeholder groups: (a) frontline providers (n=10); (b) administrators (n=10); and (c) a subset of the Black and Latinx PWUO from the multimodal intervention arm-1 (n=30); and (3) Identify the resources and estimate the associated cost of implementing and sustaining the multimodal intervention and incorporate this information into a customizable budget-impact tool and conduct a comprehensive economic evaluation to calculate the relative economic value (e.g., cost-per quality-adjusted life years, cost-per OUD treatment days) of each study arm from the healthcare sector, state policymaker, and societal perspectives which will also inform implementation framed by RE-AIM.

02

Conditions studied

  • Opioid Use Disorder

Keywords

  • Opioid Use Disorder
  • Peer Recovery Coach
  • AI-driven text tool
  • mobile health (mHealth)
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 94 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Friends Research Institute, Inc. is the lead sponsor of 44 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ≥18 years of age;
  2. fluent in English and/or Spanish;
  3. self-reported non-prescription opioid use \<30 days prior to consent;
  4. provision of informed consent;
  5. planned stay in NYC ≥12 month;
  6. self-identified Black and/or Latinx race/ethnicity;
  7. positive urine toxicology for opioids per EMR records;
  8. diagnosis of OUD per the Diagnostic and Statistical Manual of Mental Disorders-5
  9. self-reported interest in initiating buprenorphine in primary care
  10. must have a mobile phone data plan.

Exclusion criteria

Exclusion Criteria:

  1. inability to comprehend text content written at a 3rd grade reading level;
  2. physical or visual disability preventing mobile phone use;
  3. self-reported receipt of medications for OUD in past 30 days.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    Intervention Arm-1: PRC supported text+ AI driven SDH-enhanced text

    Participants in this arm will receive a combination of Peer Recovery Coaches (PRCs) supported text-based care/services coordination alongside AI-driven SDH-enhanced text messages to enhance the receipt of buprenorphine in Black/ Latin people who use opioids.

    Behavioral: PRC supported text + AI driven SDH-enhanced text

  • Experimental
    Intervention Arm-2: AI driven SDH-enhanced text only

    Participants in this arm will receive AI-driven SDH-enhanced text messages to enhance the receipt of buprenorphine in Black/ Latin people who use opioids. Unlike Arm-1, this intervention does not include the additional support and coordination provided by Peer Recovery Coaches.

    Behavioral: AI driven SDH-enhanced text only

  • Placebo comparator
    Control Arm 3- Treatment as Usual

    Control Arm-3 will receive treatment as usual (i.e., verbal instructions, NYC Dept of Health pamphlets detailing access to OUD and social services, health system smartphone application EMR patient portal).

    Behavioral: Treatment as Usual (TAU)

Interventions

  • BehavioralPRC supported text + AI driven SDH-enhanced text

    This interventional study evaluates an AI-driven texting tool combined with peer recovery coach support to deliver social services, reduce stigma, and provide patient navigation content. The goal is to enhance the receipt of buprenorphine in primary care among emergency department-enrolled Black and Latinx individuals who use opioids, addressing the disproportionate impact of opioid overdose deaths on these communities.

  • BehavioralAI driven SDH-enhanced text only

    This interventional study evaluates an AI-driven SDH-enhanced texting tool to deliver social services, reduce stigma, and provide patient navigation content. The goal is to enhance the receipt of buprenorphine in primary care among emergency department-enrolled Black and Latinx individuals who use opioids, addressing the disproportionate impact of opioid overdose deaths on these communities.

  • BehavioralTreatment as Usual (TAU)

    Control Arm-3 will receive treatment as usual (i.e., verbal instructions, NYC Dept of Health pamphlets detailing access to OUD and social services, health system smartphone application EMR patient portal).

06

What researchers measure

Primary outcomes

  1. Rate of self-reported linkage to OUD services

    The primary outcome for this efficacy study is self-reported linkage to OUD services (i.e., time to initial buprenorphine prescription that is prescribed in OBOT programs or other OUD treatment providers per the Non-study Medical and Other Services form.

    Time frame: 1 year

Secondary outcomes

  1. Number of Office-Based Opioid Treatment with buprenorphine.

    Durability of treatment effect at 52 weeks. For example, continuous retention in Office-Based Opioid Treatment with buprenorphine.

    Time frame: 1 year

  2. Number of social services received

    Total number of social services received and documented over 52 weeks.

    Time frame: 1 year

  3. Number of interactions and time spent (in minutes) engaged with the intervention

    Total number of interactions and time spent (in minutes) engaged with the intervention over 26 weeks

    Time frame: 26 weeks

07

Study locations

1 site
  • NYC Health + Hospitals
    The Bronx, New York 10451, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 13, 2024

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06569667
Lead sponsor
Friends Research Institute, Inc.
Collaborators
Nathan Kline Institute for Psychiatric Research, NYU Langone Health, Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Aug 26, 2024
Start date
Mar 28, 2025
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025
Last update
Sep 8, 2026

Study contacts

Babak Tofighi, MSc, MD
principal investigator · Friends Research Institute, Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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