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Behavioral Intervention

Buprenorphine Treatment for Opioid Use Disorder

N/A

Waitlist Available

Led By Richard S Schottenfeld, MD

Research Sponsored by Howard University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 16 years of age or older, as documented by self-report and verified by staff at the hub buprenorphine clinic

Must not have

Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent/assent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 1,2,3,4,5,6

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two ways of providing buprenorphine treatment for Black individuals with opioid use disorder (OUD). One group will receive standard treatment at a clinic, while the other group will

Who is the study for?

This trial is for African American individuals struggling with opioid use disorder (OUD). Participants should be interested in receiving treatment involving medication-assisted therapy with buprenorphine. Details on specific inclusion and exclusion criteria are not provided, but typically these would relate to health status, age, and other factors relevant to the study.

What is being tested?

The study compares two approaches: standard care using buprenorphine at a clinic (HC-MOUD Only) versus a community-based model offering telemedicine and coaching support (BT-MOUD). The goal is to see which method keeps patients in treatment longer over a period of 24 weeks after they start.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with buprenorphine can include nausea, drowsiness, constipation, headache, or sweating. Side effects from the interventions themselves may vary based on individual experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and give consent due to cognitive or developmental issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 1,2 3,4,5,6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 1,2 3,4,5,6

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1,2 3,4,5,6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Buprenorphine MOUD Treatment Retention

Secondary study objectives

Health-related quality of life (HRQOL)

Patient Health Questionnaire Depression Scale

Self-reported adherence to MOUD with buprenorphine

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) proceduresExperimental Treatment1 Intervention

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.

Group II: Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)Active Control1 Intervention

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.

0 / 2Eligibility criteria met