Opioid Use DisorderNCT06569667
Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids
A study testing PRC supported text + AI driven SDH-enhanced text, AI driven SDH-enhanced text only and Treatment as Usual (TAU) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- PRC supported text + AI driven SDH-enhanced text, AI driven SDH-enhanced text only and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Social Determinants Via Artificial Intelligence and Peer Coaching to Address Racial Disparities in Primary Care Among People Who Use Opioids
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.
- Conditions
- Opioid Use Disorder
- Being tested
- PRC supported text + AI driven SDH-enhanced text, AI driven SDH-enhanced text only, Treatment as Usual (TAU)
- Keywords
- Opioid Use Disorder, Peer Recovery Coach, AI-driven text tool, mobile health (mHealth)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRC supported text + AI driven SDH-enhanced textBehavioural
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.
AI driven SDH-enhanced text onlyBehavioural
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.
Treatment as Usual (TAU)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
Number of social services received
Total number of social services received and documented over 52 weeks.
Measured: 1 year
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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start28 Mar 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Why it stopped: Loss of sponsor funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, NYU Langone Health, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Babak Tofighi, MSc, MD, Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569667
- Sponsor's protocol ID
- R18HS029783
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Social Determinants Via Artificial Intelligence and Peer Coaching to Address Racial Disparities in Primary Care Among People Who Use Opioids
- ClinicalTrials.gov ID
- NCT06569667
- Acronym / sponsor ID
- R18HS029783
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Peer Recovery Coach, AI-driven text tool, mobile health (mHealth)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of sponsor funding
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, NYU Langone Health, Weill Medical College of Cornell University
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm-1: PRC supported text+ AI driven SDH-enhanced text | Experimental | Behavioral: PRC supported text + AI driven SDH-enhanced textParticipants 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. |
| Intervention Arm-2: AI driven SDH-enhanced text only | Experimental | Behavioral: AI driven SDH-enhanced text onlyParticipants 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. |
| Control Arm 3- Treatment as Usual | Placebo comparator | Behavioral: Treatment 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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRC supported text + AI driven SDH-enhanced textThis 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. | Behavioural | Intervention Arm-1: PRC supported text+ AI driven SDH-enhanced text |
| AI driven SDH-enhanced text onlyThis 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. | Behavioural | Intervention Arm-2: AI driven SDH-enhanced text only |
| Treatment 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). | Behavioural | Control Arm 3- Treatment as Usual |
Primary outcome
Rate of self-reported linkage to OUD services
Time frame: 1 year
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.
3 secondary outcomes
Number of Office-Based Opioid Treatment with buprenorphine.
Time frame: 1 year
Number of social services received
Time frame: 1 year
Number of interactions and time spent (in minutes) engaged with the intervention
Time frame: 26 weeks
Results and safety
The study was stopped early (reason given: Loss of sponsor funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babak Tofighi, MSc, MD principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRC supported text + AI driven SDH-enhanced text, AI driven SDH-enhanced text only and Treatment as Usual (TAU) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Loss of sponsor funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of self-reported linkage to OUD services (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.