Buprenorphine Extended-Release Subcutaneous Injection (RB... | NCT04995029

ID	Type	Description	Link
TRANSFORM	Other Identifier	Indivior

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Induction Phase: Rapid Induction	Experimental	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.	Drug: Transmucosal Buprenorphine Drug: Extended-release Buprenorphine
Induction Phase: Standard of Care Induction	Experimental	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.	Drug: Transmucosal Buprenorphine Drug: Extended-release Buprenorphine
Maintenance Phase: Extended-release Buprenorphine 100 mg	Experimental	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).	Drug: Extended-release Buprenorphine
Maintenance Phase: Extended-release Buprenorphine 300 mg	Experimental	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).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transmucosal Buprenorphine	Drug	Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38	A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 20 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.	Weeks 20 to 38
Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit	Treatment retention at Injection 2 was defined as the proportion of participants receiving Injection 2 at the Week 2 Visit among those in the Evaluable Population for Treatment Retention/Discontinuation. Participants who received Injection 2 at Week 2 (nominal) Visit and those who missed Injection 2 at Week 2 (nominal) Visit but received Injection 3 at the Week 6 Day 36 Visit were counted as "Yes" for treatment retention at Injection 2; otherwise, participants were counted as "No".	Week 2

Secondary Outcomes

Measure	Description	Time Frame
Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38	Participants' percentage of days opioids were used out of days assessed over Weeks 10 to 38 (inclusive), based on the TLFB for the prior week.	Weeks 10 to 38
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38

Eligibility Module

Eligibility Criteria

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:
1. using opioids via the injection route for an average of 5 or more days per week in the last 4 weeks.
2. 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.
Is an appropriate candidate for opioid partial-agonist medications for opioid use disorder (MOUD) in the opinion of the Investigator or medically qualified sub-Investigator.
Agrees not to use buprenorphine-containing products other than those administered as part of study treatment for the duration of the treatment period.
A female participant is eligible to participate if she 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).

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.
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.
Has any other active medical condition, organ disease or concurrent medication or treatment that may either compromise participant safety or interfere with study endpoints.
Has total bilirubin ≥ 1.5 × upper limit of normal (ULN) (with direct bilirubin > 1.3 mg/dL), alanine aminotransferase (ALT) ≥ 3 × ULN, aspartate aminotransferase (AST) ≥ 3 × ULN, serum creatinine > 2 × ULN, or international normalized ratio (INR) > 1.5 × ULN at Screening.
Has known allergy or hypersensitivity to buprenorphine or any component of the ATRIGEL Delivery System.
Is undergoing concurrent or has had prior treatment with any long-acting form of buprenorphine-containing product in the past 2 years, or if > 2 years has a positive UDS for buprenorphine at screening; treatment with oral buprenorphine, oral naltrexone or methadone products within 14 days prior to consent; or treatment with depot naltrexone within the 3 months prior to consent.
Is undergoing concurrent treatment with another investigational agent or enrollment in another clinical study (except for an observational study) or treatment with another investigational agent within 30 days prior to Screening.
Is undergoing concurrent treatment with medications contraindicated for use with buprenorphine as per local prescribing information.
Has any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures.
Is under court order requiring treatment for OUD.
Is a member of site staff and/or has a financial interest in Indivior, or is an immediate family member of either the site staff and/or Indivior employee, directly involved in the study.

Name	Affiliation	Role
Global Director Clinical Development	Indivior Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Collaborative Neuroscience Network, LLC		Garden Grove	California	92845	United States
Asclepes Research Centers

PubMed Identifier	Type	Citation	Retractions
41405885	Result	Shiwach R, Le Foll B, Alho H, Dunn KE, Strafford S, Zhao Y, Dobbins RL. Comparison of Extended-Release Buprenorphine Doses for Treating High-Risk Opioid Use: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548043. doi: 10.1001/jamanetworkopen.2025.48043.
41085986	Result	Shiwach R, Le Foll B, Alho H, Dunn KE, Strafford S, Zhao Y, Dobbins RL. Rapid vs Standard Induction to Injectable Extended-Release Buprenorphine: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537319. doi: 10.1001/jamanetworkopen.2025.37319.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Induction Phase: Rapid Induction	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. Participants are followed until Injection 3 (Week 6). Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal) Extended-release Buprenorphine: Administered by subcutaneous injection

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 7, 2022	Jun 23, 2025

Arm/Group Information

ID	Title	Description
BG000	Induction Phase: Rapid Induction	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. Participants are followed until Injection 3 (Week 6). Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal) Extended-release Buprenorphine: Administered by subcutaneous injection
BG001	Induction Phase: Standard of Care Induction	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. Participants are followed until Injection 3 (Week 6). Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal) Extended-release Buprenorphine: Administered by subcutaneous injection
BG002	Maintenance Phase: Extended-release Buprenorphine 100 mg	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). Participants are followed until Week 38. Extended-release Buprenorphine: Administered by subcutaneous injection
BG003	Maintenance Phase: Extended-release Buprenorphine 300 mg	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). Participants are followed until Week 38. Extended-release Buprenorphine: Administered by subcutaneous injection
BG004	Total	Total of all reporting groups

Baseline Measures

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Calculate Percentage

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Age, Categorical