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Opioid Partial Agonist
Buprenorphine for Opioid Use Disorder
Phase 4
Waitlist Available
Research Sponsored by Indivior Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is 18 years of age or older at the time of signing the ICF.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 30 to 38 and week 20 to 38
Awards & highlights
Study Summary
This trial will compare two methods of induction onto buprenorphine and two doses of buprenorphine for maintenance in order to find the best way to treat opioid addiction.
Who is the study for?
Adults over 18 with moderate to severe opioid use disorder, who have been using opioids for at least 90 days. They must not be pregnant or breastfeeding and agree to contraception if applicable. High-risk users include those injecting opioids frequently or using high doses of synthetic opioids like fentanyl.Check my eligibility
What is being tested?
The trial is testing extended-release Buprenorphine injections (RBP-6000) against standard treatments for opioid addiction. It looks at how well patients stick with rapid vs. standard induction onto the drug, and compares two different maintenance doses given every four weeks.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site, nausea, headache, sweating, constipation, insomnia and signs of withdrawal if transitioning from other opioids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 30 to 38 and week 20 to 38
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 30 to 38 and week 20 to 38
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit
Maintenance Phase: Percentage of Days Opioids were Used over Weeks 10 to 38
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38
Secondary outcome measures
Induction Phase: Number of Participants with Adverse Events up to Injection 2, and Between Injections 2 and 3
Induction Phase: Time to Treatment Discontinuation
Maintenance Phase: Average Dumber of Days Opioids were Used per Week by Visit
+11 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Maintenance Phase: Extended-release Buprenorphine 300 mgExperimental Treatment1 Intervention
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34).
Group II: Maintenance Phase: Extended-release Buprenorphine 100 mgExperimental Treatment1 Intervention
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34).
Group III: Induction Phase: Standard of Care InductionExperimental Treatment2 Interventions
Participants will receive transmucosal buprenorphine for a minimum of 7 days per applicable product labelling information. Participants meeting eligibility requirements will receive 300 mg extended-release buprenorphine by subcutaneous injection on Day 1 and a second dose on Day 8.
Group IV: Induction Phase: Rapid InductionExperimental Treatment2 Interventions
Participants will receive 4 mg transmucosal buprenorphine on Day 1. Participants meeting eligibility requirements will then receive 300 mg extended-release buprenorphine by subcutaneous injection at least 1 hour later and a second dose on Day 8.
Find a Location
Who is running the clinical trial?
Indivior Inc.Lead Sponsor
53 Previous Clinical Trials
10,174 Total Patients Enrolled
Global Director Clinical DevelopmentStudy DirectorIndivior Inc.
4 Previous Clinical Trials
1,078 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had thoughts of suicide or attempted suicide in the past 6 months.You are looking for medication to help with opioid use disorder (OUD).You have at least one of these signs of using opioids in a risky way at the initial screening visit:I have been using injectable opioids regularly for the past month.I have used specific medications like buprenorphine or methadone recently.I need ongoing opioid treatment for a condition other than opioid use disorder.I have not had major surgery or a serious injury in the last 30 days.I am 18 years old or older.I cannot receive injections in my stomach area.I have a history of long QT syndrome or risk factors for Torsades de Pointes.I do not have any health conditions or treatments that could affect my safety in the study.The doctor thinks it is safe for you to take medication to help with addiction to opioids.I have been using a high dose of heroin or strong synthetic opioids regularly for the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Induction Phase: Rapid Induction
- Group 2: Induction Phase: Standard of Care Induction
- Group 3: Maintenance Phase: Extended-release Buprenorphine 100 mg
- Group 4: Maintenance Phase: Extended-release Buprenorphine 300 mg
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04995029 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for volunteers in this research project?
"According to information found on clinicaltrials.gov, this research initiative is presently recruiting patients. It was first made available on October 26th 2021, and the latest revision occurred November 7th 2022."
Answered by AI
How many subjects are participating in this exploration?
"This clinical trial needs 489 patients matching the criteria for inclusion. Individuals can join this study at Prisma Health ITOR Research Pharmacy in Greenville, Oklahoma and Unity Clinical Research in Oklahoma City, North carolina among other locations."
Answered by AI
How many centers are conducting this research?
"Patients can participate in this medical study at Prisma Health ITOR Research Pharmacy located in Greenville, Oklahoma, Unity Clinical Research situated in Oklahoma City, North carolina and Monroe Biomedical Research which is based out of Monroe, California as well as an additional 24 sites."
Answered by AI
What potential risks could be associated with Extended-release Buprenorphine usage?
"The safety of extended-release buprenorphine has been established through its Phase 4 trial, and is thus assigned a score of 3."
Answered by AI
Could you provide details regarding any prior experiments involving Extended-release Buprenorphine?
"First considered for clinical application in 2012 at the Shalvata Medical Health Center, extended-release buprenorphine has since been subject to 197 trials. Of these 40 are still ongoing and Greenville, Oklahoma is a major hub of research activity."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Hassman Research Institute
Clinical Neuroscience Solutions, Inc
Collaborative Neuroscience Network, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I want to not die on the streets.
PatientReceived 1 prior treatment
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