Opioid Use Disorder
Conditions
Keywords
MOUD, OUD, Buprenorphine
Brief summary
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.
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.
Interventions
BEHAVIORALHC-MOUD Only
MOUD with buprenorphine provided in a hub buprenorphine clinic
BEHAVIORALBT-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
Sponsors
University of Illinois at Chicago
University of Miami
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
University of Maryland
Howard University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A multisite hybrid Type 1 effectiveness-implementation randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Buprenorphine MOUD Treatment Retention | 0-168 days | Duration of continuous participation in the hub clinic provided buprenorphine treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported nonmedical opioid use | 0-168 days | Number of days self-reported days of nonmedical opioid use, stimulant use, benzodiazepine use during the 168 study period |
| Self-reported nonmedical other drug use | 0-168 days | Number of days self-reported other drug use |
| Urine Toxicology | Months 1,2 3,4,5,6 | Number of opioid-negative urine toxicology tests, ranging from 0 to 6. |
| Self-reported adherence to MOUD with buprenorphine | 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 |
| Patient Health Questionnaire Depression Scale | 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. |
| Pharmacy Dispensed Buprenorphine | 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. |
| Health-related quality of life (HRQOL) | 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. |
Countries
United States
Contacts
Primary ContactRichard S Schottenfeld, MD
Backup ContactNiranjan Karnik, MD, PhD
Outcome results
None listed