Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users

NCT04995029 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: INDV-6000-401TRANSFORM
• Study Type: interventional
• Target: 785
• Locations: 2 countries
• Sites: 29

Brief 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.

Conditions

Moderate to Severe Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 (17)

• Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38

  Weeks 10 to 38

• Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38

  Weeks 10 to 38

• Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38

  Weeks 10 to 38

• Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38

  Week 30 to 38

• Maintenance Phase: Percentage of Responders for Daily Opioid Use

  Week 30 to 38

Study Arms (4)

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).

Drug: Extended-release Buprenorphine

Interventions

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)

Induction Phase: Rapid Induction; Induction Phase: Standard of Care Induction

Extended-release Buprenorphine DRUG

Administered by subcutaneous injection

Also known as: RBP-6000, SUBLOCADE

Induction Phase: Rapid Induction; Induction Phase: Standard of Care Induction; Maintenance Phase: Extended-release Buprenorphine 100 mg; Maintenance Phase: Extended-release Buprenorphine 300 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (29)

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Asclepes Research Centers

Panorama City, California, 91402, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Accel Research Sites- Lakeland Clinical Research Unit

Lakeland, Florida, 33803, United States

Location

Behavioral Clinical Research, Inc

Miami Lakes, Florida, 33016, United States

Location

Innovative Clinical Research Inc.

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Center For Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

ICAHN School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Duke Hospital

Durham, North Carolina, 27705, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Midwest Clinical Research

Dayton, Ohio, 45417, United States

Location

Pahl Pharmaceutical Professionals LLC

Oklahoma City, Oklahoma, 73112, United States

Location

SP Research, PLLC

Oklahoma City, Oklahoma, 73112, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Today Clinical Research

Oklahoma City, Oklahoma, 73120, United States

Location

Clinical Research Associates of Central PA

Altoona, Pennsylvania, 16602, United States

Location

Carolina Medical Research, LLC

Clinton, South Carolina, 29325, United States

Location

Prisma Health ITOR Research Pharmacy

Greenville, South Carolina, 29605, United States

Location

Carolina Medical Research, LLC

Greenville, South Carolina, 29607, United States

Location

David Weitzman

Myrtle Beach, South Carolina, 29577, United States

Location

Insite Clinical Research

DeSoto, Texas, 75115, United States

Location

Progressive Clinical Research

Bountiful, Utah, 84010, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (2)

• 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.

  PMID: 41405885 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.

  PMID: 41085986 RESULT

MeSH Terms

Interventions

Sublocade

Results Point of Contact

• Title: Global Director Clinical Development
• Organization: Indivior Inc.

trialdisclosure@indivior.com

(804) 594-4488

Study Officials

• Global Director Clinical Development

  Indivior Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The induction phase of the study will be open label. The maintenance phase of the study will be conducted in a double-blind manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: October 26, 2021
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: February 6, 2026
• Results First Posted: September 25, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (28)