Extended Release Buprenorphine for Opioid Use Disorder

This trial explores a new method to assist individuals with opioid use disorder in transitioning from jail back to the community. It employs BRIXADI, an extended-release version of buprenorphine, to manage cravings and withdrawal symptoms. The trial aims to evaluate the effectiveness of starting this treatment in jail and continuing it after release. It is suitable for jailed individuals eligible for release within 120 days who have a history of moderate or severe opioid use disorder. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are on medications that may cause heart rhythm issues or if you are currently receiving methadone or naltrexone in jail.

Research has shown that BRIXADI, a long-acting form of buprenorphine, is generally well-tolerated by people with opioid use disorder. One study found that 73.6% of patients continued using BRIXADI over time, indicating that most could handle the treatment without stopping early.

Another study compared BRIXADI to a daily oral medication called buprenorphine-naloxone and found similar safety levels between the two. The side effects did not differ significantly, with only about 4.7% of people discontinuing BRIXADI early due to side effects.

BRIXADI is unique because it offers an extended-release formulation of buprenorphine for treating opioid use disorder. Unlike standard treatments like daily oral buprenorphine or methadone, BRIXADI is administered as a once-weekly or once-monthly injection, which can improve adherence by reducing the need for daily medication. Additionally, this extended-release form helps maintain stable medication levels in the body, potentially reducing cravings and withdrawal symptoms more effectively. Researchers are excited about BRIXADI because it could simplify treatment regimens and enhance the quality of life for individuals struggling with opioid dependence.

Research has shown that Brixadi, a long-lasting form of buprenorphine, effectively treats opioid use disorder (OUD). In one study, 35.1% of urine tests from patients using Brixadi were opioid-free, compared to 28.4% in those using another form of buprenorphine. Another study found that 80% of patients had no opioids in their system from weeks 9 to 24. Brixadi was well-tolerated, with 73.6% of patients continuing their treatment. This treatment helps reduce cravings and withdrawal symptoms, which are crucial for managing opioid addiction. Participants in this trial will receive extended-release buprenorphine, known as Brixadi, to further evaluate its effectiveness and tolerability.²⁴⁵⁶⁷