Integrating MOUD in African American Community Settings (Better Together)

Opioid Use Disorder Clinical Trial

Official title:

Integrating MOUD in African American Community Settings (Better Together)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416020
• Other study ID #: NIDA CTN Protocol 0144
• Secondary ID: UG1DA013720
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: November 1, 2027

Study information

• Verified date: May 2024
• Source: Howard University
• Contact: Richard S Schottenfeld, MD
• Phone: 202-865-6615
• Email: richard.schottenfeld[@]howard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multisite effectiveness-implementation study will be conducted in three sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment of Black persons with OUD. 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.

Description:

This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, and Miami-Dade County 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 Black persons with OUD in MOUD with buprenorphine through six months post-randomization.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: November 1, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Be 16 years of age or older, as documented by self-report and verified by staff at the hub buprenorphine clinic.

2. Self-identify race as Black (or African American, African, or Afro-Caribbean) (self report)

3. Meets the Diagnostic Statistical Manual (DSM) -5 diagnostic criteria for current moderate or severe OUD, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record.

4. Be seeking, interested in receiving, and suitable for MOUD with buprenorphine, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record.

5. Have not received MOUD in the 30 days prior to enrolling in MOUD in the hub buprenorphine clinic (based on Prescription Drug Monitoring Program [PDMP] and self-report)

6. Willing and able to provide informed consent, and when applicable, signed assent (consent process)

7. Speak English well enough to be able to comprehend the study procedures and complete the assessments.

Exclusion Criteria:

1. Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent/assent.

2. Have a psychiatric, cognitive, or medical condition which would make participation inappropriate or contraindicated, as assessed by the hub buprenorphine clinic provider.

3. Plan to move out of the area or do not anticipate being able to remain in the study for 6 months.

4. Are unable or unwilling to provide reliable locator information.

5. Are 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.

6. They have previously enrolled in Clinical Trials Network (CTN) Protocol-0144 or are currently enrolled in another clinical trial for treatment of OUD.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• HC-MOUD Only
MOUD with buprenorphine provided in a hub buprenorphine clinic
• 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

Locations

Country	Name	City	State
United States	University of Illinois- Chicago	Chicago	Illinois
United States	University of Florida	Miami	Florida
United States	Howard University	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Howard University	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, University of Illinois at Chicago, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Buprenorphine MOUD Treatment Retention	Duration of continuous participation in the hub clinic provided buprenorphine treatment	0-168 days
Secondary	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
Secondary	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
Secondary	Self-reported nonmedical other drug use	Number of days self-reported other drug use	0-168 days
Secondary	Urine Toxicology	Number of opioid-negative urine toxicology tests, ranging from 0 to 6.	Months 1,2 3,4,5,6
Secondary	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
Secondary	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