## Protocol Section
### Identification Module
**NCT ID:** NCT06416020

**Brief Title:** Integrating MOUD in African American Community Settings (Better Together)

**Official Title:** Integrating MOUD in African American Community Settings (Better Together)

#### Organization Study ID Info
**ID:** NIDA CTN Protocol 0144
#### Organization
**Class:** OTHER
**Full Name:** Howard University
#### Secondary ID Infos
**ID:** UG1DA013720
**Link:** https://reporter.nih.gov/quickSearch/UG1DA013720
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-11-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-19
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Illinois at Chicago

**Class:** OTHER

**Name:** University of Miami

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

**Class:** INDUSTRY

**Name:** The Emmes Company, LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** Howard University

#### Responsible Party

**Investigator Affiliation:** Howard University

**Investigator Full Name:** Richard Schottenfeld

**Investigator Title:** Professor and Chair, Department of Psychiatry

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Opioid Use Disorder

**Keywords:**

- MOUD

- African American

- OUD

- Buprenorphine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** A multisite hybrid Type 1 effectiveness-implementation randomized clinical trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 330

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: HC-MOUD Only

**Label:** Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: BT-MOUD with Buprenorphine

**Label:** Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)

**Description:** MOUD with buprenorphine provided in a hub buprenorphine clinic

**Name:** HC-MOUD Only

**Other Names:**

- Hub Clinic MOUD with Buprenorphine

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures

**Description:** 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

**Name:** BT-MOUD with Buprenorphine

**Other Names:**

- Better Together MOUD with Buprenorphine

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Duration of continuous participation in the hub clinic provided buprenorphine treatment

**Measure:** Buprenorphine MOUD Treatment Retention

**Time Frame:** 0-168 days

#### Secondary Outcomes

**Description:** 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

**Measure:** Self-reported adherence to MOUD with buprenorphine

**Time Frame:** 0-168 days

**Description:** Number of days self-reported days of nonmedical opioid use, stimulant use, benzodiazepine use during the 168 study period

**Measure:** Self-reported nonmedical opioid use

**Time Frame:** 0-168 days

**Description:** Number of days self-reported other drug use

**Measure:** Self-reported nonmedical other drug use

**Time Frame:** 0-168 days

**Description:** Number of opioid-negative urine toxicology tests, ranging from 0 to 6.

**Measure:** Urine Toxicology

**Time Frame:** Months 1,2 3,4,5,6

**Description:** 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.

**Measure:** Health-related quality of life (HRQOL)

**Time Frame:** Months 1,2 3,4,5,6

**Description:** 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.

**Measure:** Patient Health Questionnaire Depression Scale

**Time Frame:** Months 1,2,3,4,5,6

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** richard.schottenfeld@howard.edu

**Name:** Richard S Schottenfeld, MD

**Phone:** 202-865-6615

**Role:** CONTACT

**Contact 2:**

**Email:** nkarnik@uic.edu

**Name:** Niranjan Karnik, MD, PhD

**Phone:** 312-273-0185

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Washington

**Contacts:**

***Contact 1:***

- **Email:** richard.schottenfeld@howard.edu

- **Name:** Richard S Schottenfeld, MD

- **Phone:** 202-865-6615

- **Role:** CONTACT

***Contact 2:***

- **Email:** d_m_scott@howard.edu

- **Name:** Denise M Scott, PhD

- **Phone:** 202-806-5264

- **Phone Ext:** Scott

- **Role:** CONTACT

***Contact 3:***

- **Name:** Richard S Schottenfeld, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Denise M Scott, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Howard University

**State:** District of Columbia

**Zip:** 20059

**Location 2:**

**City:** Miami

**Contacts:**

***Contact 1:***

- **Email:** jSzapoz@med.miami.edu

- **Name:** Jose Szapocznik, PhD

- **Role:** CONTACT

***Contact 2:***

- **Email:** bxl@med.miami.edu

- **Name:** Bijan Lochart-Rodriquez, MBA

- **Phone:** 636-387-8154

- **Role:** CONTACT

***Contact 3:***

- **Name:** Jose Szapocznik, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Viviana Horigian, MD,MHA

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** University of Florida

**State:** Florida

**Zip:** 33136

**Location 3:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Niranjan Karnik, MD, PhD

- **Phone:** 312-273-0185

- **Role:** CONTACT

***Contact 2:***

- **Email:** jkfoko@uic.edu

- **Name:** Konadu Fokuo, PhD

- **Phone:** 312-413-8357

- **Role:** CONTACT

***Contact 3:***

- **Name:** Niranjan Karnik, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Illinois- Chicago

**State:** Illinois

**Zip:** 60608

#### Overall Officials

**Official 1:**

**Affiliation:** Howard University

**Name:** Richard S Schottenfeld, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Miami

**Name:** Jose Szapocznik, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** University of Illinois- Chicago

**Name:** Niranjan Karnik, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Howard University

**Name:** Denise M. Scott, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**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.

**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/.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**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.

**URL:** https://datashare.nida.nih.gov/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000079524

- Term: Narcotic-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: HIGH

- As Found: Opioid Use Disorder

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009293

- Term: Opioid-Related Disorders

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000009292

- Term: Narcotic Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: NarcAntag

- Name: Narcotic Antagonists

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5317

- Name: Buprenorphine

- Relevance: HIGH

- As Found: Class

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M12243

- Name: Narcotic Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002047

- Term: Buprenorphine

### Misc Info Module

- Version Holder: 2024-05-31
