Extended-release Buprenorphine for Opioid Use Disorder

Overseen By Joji Suzuki

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must not be taking: Benzodiazepines, Methadone, Alcohol, others

Disqualifiers: Psychotic disorder, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who have used illicit opioids on most days in the past month, tested positive for fentanyl, and are diagnosed with Opioid Use Disorder. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I have been diagnosed with opioid addiction.

I have used illegal opioids on most days in the last month.

I am 18 or older and speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Inpatient Admission

Participants are admitted to an inpatient unit for 3 days to receive fentanyl and XR-BUP

3 days

1 visit (inpatient)

Treatment

Participants receive a single injection of XR-BUP and are monitored for withdrawal symptoms

2 days

Continuous monitoring during inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extended-release Buprenorphine

Trial Overview The study tests a new way to use extended-release Buprenorphine (XR-BUP) as a low-dose treatment to help people with opioid addiction. Participants will stay inpatient for three days, receive fentanyl to manage withdrawal symptoms, followed by XR-BUP injection.

How Is the Trial Designed?

Group I: 32mg Buprenorphine Experimental Treatment 1 Intervention

After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion.

Group II: 24mg Buprenorphine Experimental Treatment 1 Intervention

After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion.

Group III: 16mg Extended-Release Buprenorphine Experimental Treatment 1 Intervention

The first 10 participants will receive XR-BUP 16mg in single-blind fashion.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+