NCT06569667

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Mar 2025Aug 2026

First Submitted

Initial submission to the registry

August 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

March 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

August 12, 2025

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

August 12, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

Opioid Use DisorderPeer Recovery CoachAI-driven text toolmobile health (mHealth)

Outcome Measures

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.

    1 year

Secondary Outcomes (3)

  • Number of Office-Based Opioid Treatment with buprenorphine.

    1 year

  • Number of social services received

    1 year

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

    26 weeks

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Control Arm 3- Treatment as Usual

PLACEBO COMPARATOR

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

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.

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

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.

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

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).

Control Arm 3- Treatment as Usual

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYC Health + Hospitals

The Bronx, New York, 10451, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Babak Tofighi, MSc, MD

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Babak Tofighi, MSc, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 26, 2024

Study Start

March 28, 2025

Primary Completion

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

August 12, 2025

Record last verified: 2024-09

Locations