HC-MOUD Only
BehavioralMOUD with buprenorphine provided in a hub buprenorphine clinic
Other names: Hub Clinic MOUD with Buprenorphine
NCT Number: NCT06416020
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.
Trial opening soon.
Get Notified16 year and older
All sexes
Interventional
Not applicable
Howard University, Washington D.C., District of Columbia, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MOUD with buprenorphine provided in a hub buprenorphine clinic
Other names: 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
Other names: Better Together MOUD with Buprenorphine
Time frame: 0-168 days
Duration of continuous participation in the hub clinic provided buprenorphine treatment
Time frame: 0-168 days
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
Number of days self-reported days of nonmedical opioid use, stimulant use, benzodiazepine use during the 168 study period
Time frame: 0-168 days
Number of days self-reported other drug use
Time frame: Months 1,2 3,4,5,6
Number of opioid-negative urine toxicology tests, ranging from 0 to 6.
Time frame: Months 1,2 3,4,5,6
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
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
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.
Contact information is provided by the study sponsor or research team.
Niranjan Karnik, MD, PhD
CONTACT
Richard S Schottenfeld, MD
CONTACT
Howard University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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