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Opioid Agonist
extended-release buprenorphine (XR-B) for Opioid Use Disorder
Phase 3
Waitlist Available
Research Sponsored by Friends Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
Study Summary
This trial will compare two forms of buprenorphine treatment for adults with opioid use disorder who are about to be released from a large city jail. Participants will be randomly assigned to receive either extended
Who is the study for?
This trial is for adults in a large metropolitan jail with moderate-to-severe opioid use disorder (OUD) who are soon to be released. Participants will continue treatment after release and attend follow-up visits up to 12 months.Check my eligibility
What is being tested?
The study compares two forms of buprenorphine: extended-release (XR-B) versus sublingual (SL-B). It's an open-label trial, meaning everyone knows which treatment they're getting, with participants randomly assigned to either group.See study design
What are the potential side effects?
Buprenorphine can cause side effects like nausea, drowsiness, constipation, headache, or sweating. Since it's used for OUD treatment, the focus is on managing withdrawal symptoms and reducing cravings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
days of opioid use
time to opioid relapse
urine toxicology
Secondary outcome measures
HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score
HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score
PROMIS Patient-Reported Outcomes Measurement Information System - mental health
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: extended-release buprenorphine (XR-B)Experimental Treatment1 Intervention
Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.
Group II: sublingual buprenorphine (SL-B)Active Control1 Intervention
Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone.
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Who is running the clinical trial?
Friends Research Institute, Inc.Lead Sponsor
52 Previous Clinical Trials
20,368 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for patients to participate in this clinical trial?
"The ongoing trial, as documented on clinicaltrials.gov, is not seeking new participants at this moment. Originally shared on June 1st, 2024, with the most recent update made on March 5th, 2024. While recruitment for this specific study is paused currently, it's worth noting that there are presently active enrollment opportunities in 282 other research investigations."
Answered by AI
What is the safety profile of extended-release buprenorphine (XR-B) in individuals?
"The safety rating for extended-release buprenorphine (XR-B) has been graded as a 3 by our team at Power, aligning with the Phase 3 trial status. This indicates existing evidence supporting both effectiveness and multiple reassurances regarding safety profile."
Answered by AI
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