Integrating MOUD in Nonmedical Community Settings (Better Together)

A multisite effectiveness-implementation study will be conducted in four sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment persons with Opioid Use Disorder (OUD) in urban neighborhoods with high overdose rates. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: HC-MOUD Only; Behavioral: BT-MOUD with Buprenorphine

Detailed Description

This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, Miami-Dade County and Baltimore will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilitators. In the BT-MOUD intervention, community sites serve as "spokes" for telemedicine provision of MOUD by buprenorphine providers based in a "hub" buprenorphine clinic. A trained and supervised Recovery Guide with roots or connections with the community provides manual-guided Recovery Guiding on-site in the community site. Recovery Guiding includes psychoeducation (about OUD and effective buprenorphine MOUD) and behavioral counseling to promote engagement in MOUD with buprenorphine, retention in care, medication adherence, and behavioral change supportive of recovery. In HC-MOUD Only, participants will receive MOUD with buprenorphine and other available services in the hub buprenorphine clinic only. A Peer Outreach Specialist (POS) will assist with outreach and recruitment of all participants across conditions and with maintaining high rates of follow-up in research assessments. This study will test the hypothesis that BT-MOUD is more effective than HC-MOUD Only in retaining persons with OUD in MOUD with buprenorphine through six months post-randomization.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard S Schottenfeld, MD; Phone Number: 202-865-6615; Email: richard.schottenfeld@howard.edu
• Study Contact Backup: Name: Niranjan Karnik, MD, PhD; Phone Number: 312-273-0185; Email: nkarnik@uic.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20059
      • Howard University
      • Contact: Richard S Schottenfeld, MD; Phone Number: 202-865-6615; Email: richard.schottenfeld@howard.edu
      • Contact: Denise M Scott, PhD; Phone Number: Scott 202-806-5264; Email: d_m_scott@howard.edu
      • Principal Investigator: Richard S Schottenfeld, MD
      • Sub-Investigator: Denise M Scott, PhD
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Contact: Bijan Lochart-Rodriquez, MBA; Phone Number: 636-387-8154; Email: bxl@med.miami.edu
      • Contact: Viviana Horigian, MD, MHA; Email: vhorigian@med.miami.edu
      • Principal Investigator: Viviana Horigian, MD, MHA
      • Sub-Investigator: Jose Szapocznik, PhD
  • Illinois
    • Chicago, Illinois, United States, 60608
      • University of Illinois- Chicago
      • Principal Investigator: Niranjan Karnik, MD, PhD
      • Contact: Niranjan Karnik, MD, PhD; Phone Number: 312-273-0185
      • Contact: Konadu Fokuo, PhD; Phone Number: 312-413-8357; Email: jkfoko@uic.edu
  • Maryland
    • Baltimore, Maryland, United States, 21223
      • University of Maryland
      • Principal Investigator: Eric Weintraub, MD
      • Contact: Eric Weintraub, MD; Phone Number: 410-328-7919; Email: eweintra@som.umaryland.edu
      • Contact: Heather Fitzsimons, MPH; Phone Number: 443-462-3400; Email: hfitzsimons@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Be 16 years of age or older
2. Has been newly prescribed MOUD with buprenorphine by a hub clinic provider no more than 10 days before the day of randomization or on the day of randomization [Note that the "start" of a "current, new treatment episode" of MOUD with buprenorphine is defined as the date MOUD with buprenorphine was prescribed by a hub clinic provider.]
3. Is willing and able to provide written informed consent
4. Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments
5. Speaks English well enough to be able to comprehend the study procedures and complete the assessments

Exclusion Criteria:

1. In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has either taken prescribed MOUD as an outpatient for more than 10 consecutive days OR received injectable MOUD that covers more than 10 consecutive days [Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.]
2. Plans to move out of the area or anticipate not being able to remain in the study for 6 months
3. Is currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
4. Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hub Clinic MOUD with buprenorphine only (HC-MOUD Only); Participants will receive MOUD with buprenorphine prescribed by providers based at participating hub clinics. MOUD treatment with buprenorphine will follow standard guidelines for induction and maintenance using a sublingual buprenorphine formulation. Hub clinic buprenorphine providers and participants may shift to long acting injection buprenorphine formulations after initial induction with sublingual buprenorphine. If telemedicine prescribing of MOUD with buprenorphine is part of the usual standard of care at the clinic, participants assigned to HC-MOUD Only may be prescribed buprenorphine via telemedicine, following the clinic's usual guidelines. Participants may not receive telemedicine services at the community spokes or Recovery Guiding, which are available only to participants assigned to BTMOUD. All study participants, however, may have access to any services that are routinely provided as part of the MOUD with buprenorphine treatment-as-usual care in the hub clinic.	Behavioral: HC-MOUD Only; MOUD with buprenorphine provided in a hub buprenorphine clinic; Other Names: Hub Clinic MOUD with Buprenorphine
Experimental: Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures; Better Together Medications for Opioid Use Disorder (BT-MOUD) includes HC-MOUD plus access to telemedicine provision of MOUD with buprenorphine at a nonmedical community organization spoke, plus manual-guided Recovery Guiding provided onsite at the spoke, and plus any other services available at the community organization spoke. Recovery Guiding is a manualized, highly structured, stepwise intervention that uses educational and behavioral tools to provide pragmatic guidance for patients beginning buprenorphine treatment and to address the key recovery misconceptions and dysfunctional behaviors that frequently interfere with recovery efforts of patients initiating medication for opioid use disorder (MOUD) treatment.	Behavioral: BT-MOUD with Buprenorphine; MOUD with buprenorphine provided by a hub buprenorphine provider either in the hub clinic or via telemedicine at a community hub; Recovery Guiding provided to participants; Other Names: Better Together MOUD with Buprenorphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buprenorphine MOUD Treatment Retention	Duration of continuous participation in the hub clinic provided buprenorphine treatment	0-168 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported adherence to MOUD with buprenorphine	Number of days self-reported adherence to MOUD with buprenorphine assessed using timeline follow back (TLFB) Adherence to buprenorphine during the 168-day study period	0-168 days
Self-reported nonmedical opioid use	Number of days self-reported days of nonmedical opioid use, stimulant use, benzodiazepine use during the 168 study period	0-168 days
Self-reported nonmedical other drug use	Number of days self-reported other drug use	0-168 days
Urine Toxicology	Number of opioid-negative urine toxicology tests, ranging from 0 to 6.	Months 1,2 3,4,5,6
Health-related quality of life (HRQOL)	Assess quality of life using the Health-related Quality of Life Health Related Quality of Life -4: Scores range from 1-5 for Q1, assessing overall health-related quality of life, and from 0-30 for Q2, Q3, and Q4 assessing physical health (Q2), mental health (Q3), and interference from health or mental health problems (Q4); higher scores indicate worse outcomes.	Months 1,2 3,4,5,6
Patient Health Questionnaire Depression Scale	Assess depressive symptoms using Patient Health Questionnaire Depression Scale-8 (PHQ-8). Scores range from 0 to 24. Higher scores are indicators of greater depression severity.	Months 1,2,3,4,5,6
Pharmacy Dispensed Buprenorphine	Data regarding HUB clinic prescribed buprenorphine that is dispensed to the participant by a pharmacy will be obtained as part of the abstraction of data from electronic medical and pharmacy records.	Months 1, 2, 3, 4, 5, 6

Collaborators and Investigators

• Sponsor: Howard University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Miami; University of Maryland; University of Illinois at Chicago; The Emmes Company, LLC
• Investigators: Principal Investigator: Richard S Schottenfeld, MD, Howard University; Study Director: Denise M. Scott, PhD, Howard University; Principal Investigator: Viviana Horigian, MD, MHA, University of Miami; Principal Investigator: Niranjan Karnik, MD, PhD, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Buprenorphine; OUD; MOUD
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Buprenorphine
• Other Study ID Numbers: NIDA CTN Protocol 0144; UG1DA013720 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will comply with the NIH Policy for Data Management and Sharing (Notice Number: NOT-OD-21-013) (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and for Helping to End Addiction Long-Term (HEAL) funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal initiative/research/heal public-access-data-sharing-policy)]. For more details on data sharing please visit https://datashare.nida.nih.gov/.
• IPD Sharing Time Frame: Datasets for Clinical Trials Network Protocol -144 (CTN-0144) will be available when either (1) the primary outcome paper has been accepted for publication, (2) the data has been locked for more than 18 months, or (3) the grant concludes; whichever comes first. The datasets will remain accessible via NIDA Data Share contingent on NIDA's continued support of the archive. To date, NIDA Data Share has not deleted any deposited data.
• IPD Sharing Access Criteria: Access to the scientific data generated from CTN-0144 will be controlled via a registration agreement for data use on the NIDA Data Share Website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No