Buprenorphine for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Indivior Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD).

Meets at least 1 of the 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 or self-reported use of highly potent synthetic opioids for an average of 5 or more days per week in the last 4 weeks, seeking medication for the treatment of OUD, being an appropriate candidate for opioid partial-agonist medications for OUD, agreeing not to use buprenorphine-containing products other than those administered as part of study treatment for the duration of the treatment period, being a female participant who is not pregnant, not lactating, and, if of childbearing potential, agrees not to become pregnant while on the study and to use medically acceptable means of contraception while on the study.

Has signed the informed consent form (ICF) and is able and willing to comply with the requirements and restrictions listed therein.

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Exclusion Criteria

I have not had thoughts of suicide or attempted suicide in the past 6 months.

I have used specific medications like buprenorphine or methadone recently.

Is undergoing concurrent treatment with another investigational agent, enrollment in another clinical study, treatment with medications contraindicated for use with buprenorphine, or has pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures.

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Treatment Details

Interventions

Extended-release Buprenorphine (Opioid Partial Agonist)
Transmucosal Buprenorphine (Opioid Partial Agonist)

Trial OverviewThe 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.

Participant Groups

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.