Injectable Buprenorphine for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how two types of monthly injectable medications, Sublocade and Brixadi, assist individuals with opioid use disorder (OUD) in maintaining treatment after leaving prison. Researchers seek to identify which treatment proves more effective and whether allowing participants to choose their medication enhances their commitment to treatment. The trial seeks individuals who are currently incarcerated, diagnosed with OUD, part of a specific treatment program, and interested in trying these injections. Researchers will monitor participants for six months post-release to assess treatment success and any side effects. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand how they 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 healthcare provider.
What is the safety track record for these treatments?
Studies have shown that both Sublocade and Brixadi are treatments for opioid use disorder (OUD) that most people tolerate well. In a study on Brixadi, about 4.7% of patients discontinued the treatment early due to side effects. However, it maintained a high treatment retention rate of 73.6%, indicating that many patients continued with the treatment over time. Brixadi has also proven effective and safe for long-term use, with patients showing ongoing improvement in staying off opioids.
Similarly, Sublocade has demonstrated good safety and effectiveness. Research indicates that after 12 months of treatment, many patients were free from illegal opioid use. Some patients experienced withdrawal symptoms, reported by 31.4% and 25.1% of patients in different study groups, suggesting that Sublocade is generally well-tolerated.
Both Sublocade and Brixadi have FDA approval for treating OUD, supporting their safety. This trial will explore how these treatments work for people leaving prison and whether having a choice between them affects treatment success.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about injectable buprenorphine treatments like Brixadi and Sublocade for opioid use disorder because they offer new delivery methods and potential benefits over traditional oral medications. Unlike daily oral buprenorphine, these injectable forms provide sustained release, ensuring consistent medication levels in the body, which can improve compliance and reduce the risk of relapse. Additionally, these treatments simplify the dosing schedule to monthly injections, which can enhance convenience and help prevent misuse associated with daily dosing. These innovations could make a significant difference in how effectively opioid use disorder is managed.
What evidence suggests that this trial's treatments could be effective for opioid use disorder?
This trial will compare the effectiveness of two injectable forms of buprenorphine: Sublocade and Brixadi. Research has shown that both are effective in treating opioid use disorder (OUD). Specifically, studies found that Sublocade significantly reduces the use of illegal opioids over several weeks compared to a placebo. In contrast, Brixadi demonstrated that about 73.6% of patients continue their treatment, indicating a high retention rate. Both treatments help manage withdrawal symptoms and cravings, making them strong options for reducing opioid use. Experts agree that these injectable forms of buprenorphine effectively manage OUD, providing a solid basis for their use in treatment.25678
Are You a Good Fit for This Trial?
This trial is for adults in prison who have opioid use disorder, are already in a medication program for it, expect to be released within about 4 months, are interested in monthly injectable buprenorphine (Sublocade or Brixadi), and can speak English.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive monthly injections of either Sublocade or Brixadi before and after release from prison
Follow-up
Participants are monitored for treatment retention, opioid use, and adverse events post-release
Open-label extension (optional)
Participants may continue treatment based on preference and clinical assessment
What Are the Treatments Tested in This Trial?
Interventions
- Brixadi
- Sublocade
Trial Overview
The study compares two monthly injectable forms of buprenorphine—Sublocade and Brixadi—to see which helps people stay in treatment after leaving prison. Participants either choose their preferred injection or are randomly assigned if they have no preference.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants receive Sublocade-branded injectable buprenorphine.
Participants receive Brixadi-branded injectable buprenorphine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lifespan
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Buvidal/Brixadi - a long-acting injectable buprenorphine ...
Buprenorphine reduces opioid withdrawal symptoms, cravings, and the effects of additional opioid use. Buvidal has similar side effects and ...
Phase 3 Pivotal Study | BRIXADI® (buprenorphine) ...
Patient response to treatment with BRIXADI was noninferior to treatment with SL BPN/NX · At least 8 of 10 (80%) negative opioid assessments from weeks 9 to 24 ...
Publication of Ph 3 Study Showing Long-term Safety & ...
Individualized treatment with BRIXADI weekly and monthly was well-tolerated and effective, with a high (73.6%) treatment retention of patients throughout the ...
The Effectiveness and Value of Extended-Release Opioid ...
We compared the cost-effectiveness of Probuphine, Brixadi, and Vivitrol with sublingual buprenorphine/naloxone using a Markov model. Due to a ...
Extended-Release 7-Day Injectable Buprenorphine for ...
Buprenorphine treatment of opioid use disorder (OUD) is effective in engaging patients in addiction treatment and reducing illicit opioid use ...
Clinical Safety | BRIXADI® (buprenorphine) extended- ...
Adverse reactions led to premature discontinuation in 10 (4.7%) patients in the group receiving BRIXADI compared with 5 (2.3%) patients in the SL BPN/NX group ...
Effectiveness and safety of therapies for patients with opioid ...
The analysis included 98 studies. Monthly injectable buprenorphine (BUP-XR) showed the highest likelihood of helping people stay on treatment ...
210136Orig1s000 - accessdata.fda.gov
BRIXADI (buprenorphine) is an extended-release subcutaneous depot injection intended for the treatment of moderate to severe opioid use disorder (OUD) in ...
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