Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
United States785 participantsStarted 2021-10-26
Plain-language summary
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine.
The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Has signed the informed consent form (ICF) and is able and willing to comply with the requirements and restrictions listed therein.
✓. Is 18 years of age or older at the time of signing the ICF.
✓. Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD).
✓. Has a history of OUD as defined by documented medical history of OUD for at least 90 days immediately prior to providing informed consent.
✓. Meets at least 1 of these criteria for high-risk opioid use at the Screening visit:
✓. using opioids via the injection route for an average of 5 or more days per week in the last 4 weeks.
✓. using at least 500 mg IV heroin equivalent (e.g., 1250 mg intravenous (IV) morphine) or self-reported use of any dose of highly potent synthetic opioids (fentanyl and analogues excluding transdermal patches) for an average of 5 or more days per week in the last 4 weeks by any route.
✓. Is seeking medication for the treatment of OUD.
Exclusion criteria
✕. Has current diagnosis, other than OUD, requiring chronic opioid treatment.
✕. Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
✕
What they're measuring
1
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38
Timeframe: Weeks 20 to 38
2
Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit
. Meets DSM-5 criteria for severe alcohol use disorder.
✕. Has had significant traumatic injury or major surgical procedure (as defined by the Investigator) within 30 days prior to the first dose of RBP-6000 or still recovering from prior such injury or surgery.
✕. Has congenital long QT syndrome, history of prolonged QT in the 3 months prior to Screening, or history of medications or other factors that are at risk for Torsades de Pointes.
✕. Has abdominal area unsuitable for subcutaneous injections (e.g., nodules, scarring, lesions, excessive pigment).
✕. Has history of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent.
✕. Has uncontrolled intercurrent illness including, but not limited to, a medical or psychiatric illness/social situation that would limit compliance with study requirements or compromise the ability of the participant to provide written informed consent.