Buprenorphine for Opioid Use Disorder

Overseen By Angela Di Paola

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Yale University

Must be taking: Buprenorphine

Disqualifiers: Pregnancy, Suicidal ideation, Hepatic impairment, 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: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a monthly buprenorphine injection for treating opioid use disorder (OUD) at a mobile pharmacy clinic. The goal is to determine if participants find this treatment method convenient and acceptable. It targets individuals with moderate to severe OUD who are willing to try weekly or monthly injections and can stay in the area for the study's duration. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Buprenorphine?

Research has shown that buprenorphine is generally safe when used as prescribed to treat opioid addiction. It helps reduce withdrawal symptoms and cravings. Some individuals have reported dental problems, such as tooth decay and cavities, particularly when buprenorphine is taken in forms that dissolve in the mouth. However, this trial uses injections, which may help avoid those specific issues.

Buprenorphine is a controlled substance, so there is some risk of addiction or misuse. Taking too much can be dangerous, especially when switching from another opioid. Therefore, it is crucial to follow the dosing instructions carefully. Anyone considering this treatment should weigh these factors and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for opioid use disorder, which often involves daily oral medications, buprenorphine in this trial is administered through weekly or monthly injections. This unique delivery method can enhance adherence to the treatment plan by reducing the burden of daily dosing, making it easier for patients to stick with their treatment. Researchers are excited about this approach because it not only simplifies the treatment process but also potentially improves outcomes for patients struggling with opioid addiction by providing consistent medication levels in the body.

What is the effectiveness track record for buprenorphine in treating opioid use disorder?

Research has shown that buprenorphine, which participants in this trial will receive, effectively treats opioid use disorder (OUD). Studies have found that medications like buprenorphine significantly lower the risk of overdose and death in people with OUD. In one study, 86% of patients who received buprenorphine in an emergency room continued their OUD treatment, and 50% remained engaged over time. Buprenorphine also helps people adhere to their treatment long-term, with patients staying on it for over two years on average. Overall, buprenorphine is a proven option for managing OUD, helping to stabilize patients and reduce harm. ^{6 7 8 9 10}

Who Is on the Research Team?

Sandra Springer, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with opioid use disorder who are interested in trying a monthly extended-release buprenorphine injection as treatment. Participants will receive care on a mobile pharmacy clinic and be part of the study for 6 months.

Inclusion Criteria

Current or history of DSM-5 moderate-to-severe OUD per Rapid Opioid Use Disorder Assessment (ROUDA)

Not planning to move out of state or to a new location during study enrollment

I can sign the consent form in English or Spanish.

Exclusion Criteria

Pregnancy

Violent or threatening behavior toward staff and/or others

Allergy, hypersensitivity, or medical contraindication to medication (the BRIXADI needle cap is synthetically derived from natural rubber latex which may cause allergic reactions in persons with latex-sensitivity)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly or weekly extended-release subcutaneous buprenorphine (BRIXADI) injections to treat opioid use disorder

6 months

Monthly or weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine

Trial Overview The trial is testing the acceptability and feasibility of using extended-release subcutaneous buprenorphine (BRIXADI; XR-B) administered monthly or weekly to treat opioid dependence on a mobile pharmacy clinic.

How Is the Trial Designed?

Group I: Buprenorphine Experimental Treatment 1 Intervention

Participants will be offered weekly or monthly Buprenorphine injections

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Braeburn Inc

Collaborator

Citations

1. nih.gov nih.gov/news-events/news-releases/higher-doses-buprenorphine-may-improve-treatment-outcomes-people-opioid-use-disorder

Higher doses of buprenorphine may improve treatment ... These findings suggest that higher buprenorphine doses could be more effective in managing opioid use disorder, which may be particularly relevant for ...

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates Medications for opioid use disorder (OUD), particularly buprenorphine and methadone, substantially reduce overdose-related and overall mortality ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814325

Emergency Department Access to Buprenorphine for ... Findings In this cohort study of 464 patients with OUD, 86% received buprenorphine treatment in the ED and 50% remained engaged in OUD treatment ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037687162400173X

Nine-year substance use treatment outcomes with ... Buprenorphine treatment retention at a FQHC was successful (mean of over 2 years). Mean yearly patient retention was 69% taking into account treatment gaps.

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/6/e095645

Effectiveness of methadone versus buprenorphine in the ... We find that there is no statistically significant difference in ongoing non-prescribed opioid use between patients receiving MMT compared with bup/nal.

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

What is Buprenorphine? Side Effects, Treatment & Use When taken as prescribed, buprenorphine is safe and effective. Buprenorphine has unique pharmacological properties that: Diminish the effects of ...

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder

FDA warns about dental problems with buprenorphine ... FDA is warning that dental problems such as tooth decay, cavities, oral infections, and loss of teeth have been reported with buprenorphine ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6585403/

Buprenorphine Treatment for Opioid Use Disorder We provide a review of the use of buprenorphine for treatment of opioid use disorder and discuss barriers, challenges, risks, and the efficacy of buprenorphine ...

9. labeling.pfizer.com labeling.pfizer.com/ShowLabeling.aspx?id=5413

Buprenorphine Hydrochloride Injection, for intravenous ... Overestimating the buprenorphine hydrochloride dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

10. butrans.com butrans.com/safety-information-indication

Safety Information & Indication BUTRANS contains buprenorphine, a Schedule III controlled substance. As an opioid, BUTRANS exposes users to the risks of addiction, abuse, and misuse. Because ...