An interventional study of HC-MOUD Only and BT-MOUD with Buprenorphine in Opioid Use Disorder, sponsored by Howard University. Not yet recruiting at 4 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Howard University · Not applicable, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 400 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Howard University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 in a hub buprenorphine clinic
Also known as: Hub Clinic 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
Also known as: Better Together MOUD with Buprenorphine
Buprenorphine MOUD Treatment Retention
Duration of continuous participation in the hub clinic provided buprenorphine treatment
Time frame: 0-168 days
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
Time frame: 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
Time frame: 0-168 days
Self-reported nonmedical other drug use
Number of days self-reported other drug use
Time frame: 0-168 days
Urine Toxicology
Number of opioid-negative urine toxicology tests, ranging from 0 to 6.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Months 1, 2, 3, 4, 5, 6
Plan to share: Yes — 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/.
Supporting information: Study protocol, Sap, Icf, Csr
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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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