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 trial tests a new method to initiate treatment for individuals with Opioid Use Disorder (OUD) using extended-release buprenorphine, a medication that helps manage withdrawal symptoms. Researchers aim to understand the safety and pharmacokinetics of this treatment. Participants will receive varying doses and undergo close monitoring to assess their body's reactions. The trial seeks individuals who have frequently used illicit opioids in the past month and have a positive urine test for fentanyl. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you've taken certain medications like buprenorphine, methadone, or specific drugs affecting liver enzymes in the past 30 days.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that extended-release buprenorphine (XR-BUP) is generally safe for people with opioid use disorder. One study found it effective for patients with mild withdrawal symptoms. Another study confirmed its safety for adults.

Although limited safety information exists for teenagers, the treatment is approved for adults. Patients should not mix it with other medications or alcohol without consulting a doctor. Overall, evidence suggests that XR-BUP is a safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Extended-release Buprenorphine is unique because it offers a once-monthly injection option for treating opioid use disorder, unlike standard treatments such as daily oral Buprenorphine. This extended-release formulation can improve adherence by reducing the need for daily dosing, which can be a significant barrier for some patients. Researchers are excited about this treatment because it maintains steady medication levels in the body, potentially reducing cravings and withdrawal symptoms more consistently than daily treatments. With dose options of 16mg, 24mg, and 32mg, it caters to individual patient needs, offering flexibility in managing the disorder effectively.

What evidence suggests that extended-release buprenorphine might be an effective treatment for opioid use disorder?

Research shows that extended-release buprenorphine (XR-BUP) effectively treats opioid use disorder (OUD). Studies have found that XR-BUP reduces drug use and keeps people in treatment longer than other treatments. For instance, one study found fewer positive urine tests for opioids among XR-BUP users. Another study showed that participants remained in treatment for six months and that XR-BUP was generally safe. Additionally, only a small number of patients experienced withdrawal symptoms when switching to XR-BUP. These findings suggest XR-BUP is a promising option for managing OUD. ^{1 6 7 8 9}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38940929/

Feasibility and effectiveness of extended-release ... Compared to other MOUD, XR-BUP significantly reduced drug use, resulted in similar or higher treatment retention rates, fewer re-incarcerations, ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840042

Rapid vs Standard Induction to Injectable Extended ... This randomized clinical trial compares the safety and effectiveness of rapid induction and standard induction onto extended-release ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0376871625002510

Extended-release injectable buprenorphine for the ... The primary outcome was 6-month retention in XR-BUP treatment. Secondary outcomes included use of illicit opioids and safety. Results. Participants were mostly ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40459195/

Transition to Extended-release Buprenorphine Injectable ... For Bup-XR-S studies, 75 patients transitioned to Bup-XR-S within 24 hours. Of patients, 4% experienced withdrawal symptoms requiring additional ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06023459

Extended-release Buprenorphine Compared to Sublingual ... The measure for the main comparative effectiveness outcome is number of urine drug screen (UDS) results negative for opioids at scheduled assessments during ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820859

Extended-Release 7-Day Injectable Buprenorphine for ... 7-day extended-release buprenorphine may be feasible in patients with opioid use disorder presenting with minimal to mild Clinical Opiate Withdrawal Scale ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39543001/

A Single-Dose Study to Evaluate the Relative ... Serial blood samples were taken to measure buprenorphine plasma concentrations over 28 days and assess buprenorphine relative bioavailability.

8. samhsa.gov samhsa.gov/substance-use/treatment/options/buprenorphine

What is Buprenorphine? Side Effects, Treatment & Use Buprenorphine Safety Precautions · Do not take other medications without first consulting your doctor. · Do not use illegal drugs, drink alcohol, ...

9. innovationdistrict.childrensnational.org innovationdistrict.childrensnational.org/extended-release-buprenorphine-for-treatment-of-adolescent-opioid-use-disorder/

Extended-release buprenorphine for treatment of adolescent ... Extended-release buprenorphine has been shown to be a safe and effective medication in adults but not offered to adolescents due to lack of safety data.