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Extended Release Buprenorphine for Opioid Use Disorder

Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Friends Research Institute, Inc.
Must be taking: Buprenorphine
Must not be taking: Methadone, Naltrexone, Antidepressants, Antipsychotics
Disqualifiers: Unstable diabetes, Heart disease, Others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is an open label pilot study of 30 incarcerated men and women receiving sublingual buprenorphine (SL-B) in jail who will voluntarily switch to extended-release buprenorphine (BRIXADI) using telemedicine prior to release. Individuals will receive weekly XR-B and at least one monthly XR-B injection prior to release. Individuals will be linked to a community treatment provider where they will continue their treatment (buprenorphine) post-release. Participants will be assessed at 1,2-, and 3-months post release

Are You a Good Fit for This Trial?

Inclusion Criteria

I am an adult inmate eligible for release from this jail within 120 days.
I have a history of moderate or severe opioid use disorder or was in opioid treatment before jail.
3. Suitability for XR-B treatment as determined by medical evaluation;
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly XR-B injections and at least one monthly XR-B injection prior to release using telemedicine

Duration until release (variable)
Weekly visits (telemedicine)

Post-release Treatment

Participants continue buprenorphine treatment with a community provider post-release

3 months
Monthly visits (in-person)

Follow-up

Participants are monitored for medication adherence, illicit opioid use, and overdose incidents

3 months post-release
Assessments at 1, 2, and 3 months post-release

What Are the Treatments Tested in This Trial?

Interventions

  • BRIXADI

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: XR-BExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials
60
Recruited
22,500+

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