Health TrialsbyHealthPanel

Integrating MOUD in Nonmedical Community Settings (Better Together)

ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHoward University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be 16 years of age or older

Has been newly prescribed MOUD with buprenorphine by a hub clinic provider no more than 90 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.]

Is willing and able to provide written informed consent

Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments

Disqualifiers

In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has been covered by MOUD (oral, sublingual, injection) as an outpatient for more than 10 consecutive days. [Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.]

Plans to move out of the area or anticipate not being able to remain in the study for 6 months

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

Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD

Trial design

Design model

Parallel

Treatments tested in this trial

  • HC-MOUD Only

    Behavioral

    MOUD with buprenorphine provided in a hub buprenorphine clinic

  • BT-MOUD with Buprenorphine

    Behavioral

    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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)Active comparator 1 intervention
Group B: Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) proceduresExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Buprenorphine MOUD Treatment Retention

Duration of continuous participation in the hub clinic provided buprenorphine treatment

Time frame
0-168 days

Secondary outcomes

1

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
2

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
3

Self-reported nonmedical other drug use

Number of days self-reported other drug use

Time frame
0-168 days
4

Urine Toxicology

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

Time frame
Months 1,2 3,4,5,6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Howard University

Lead sponsor

University of Illinois at Chicago

Collaborator

University of Miami

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

The Emmes Company, LLC

Collaborator

University of Maryland

Collaborator

Source ClinicalTrials.gov
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