Moderate to Severe Opioid-use DisorderPhase 4NCT04995029
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
A Phase 4 study testing Transmucosal Buprenorphine and Extended-release Buprenorphine in people with Moderate to Severe Opioid-use Disorder, run by Indivior Inc. at 29 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Opioid-use Disorder
- What is being tested?
- Transmucosal Buprenorphine and Extended-release Buprenorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 785 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 26 Oct 2021to 26 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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).
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
Clinical Research Associates of Central PA
Altoona, Pennsylvania, 16602
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Hassman Research Institute
Berlin, New Jersey, 08009
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Progressive Clinical Research
Bountiful, Utah, 84010
Center For Emotional Fitness
Cherry Hill, New Jersey, 08002
Carolina Medical Research, LLC
Clinton, South Carolina, 29325
Alpine Research Organization
Clinton, Utah, 84015
Midwest Clinical Research
Dayton, Ohio, 45417
Insite Clinical Research
DeSoto, Texas, 75115
Duke Hospital
Durham, North Carolina, 27705
Sarkis Clinical Trials
Gainesville, Florida, 32607
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845
Prisma Health ITOR Research Pharmacy
Greenville, South Carolina, 29605
Carolina Medical Research, LLC
Greenville, South Carolina, 29607
Accel Research Sites- Lakeland Clinical Research Unit
Lakeland, Florida, 33803
Behavioral Clinical Research, Inc
Miami Lakes, Florida, 33016
Monroe Biomedical Research
Monroe, North Carolina, 28112
David Weitzman
Myrtle Beach, South Carolina, 29577
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029
Innovative Clinical Research Inc.
North Miami, Florida, 33161
Pahl Pharmaceutical Professionals LLC
Oklahoma City, Oklahoma, 73112
SP Research, PLLC
Oklahoma City, Oklahoma, 73112
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Today Clinical Research
Oklahoma City, Oklahoma, 73120
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
Asclepes Research Centers
Panorama City, California, 91402
Artemis Institute for Clinical Research
San Diego, California, 92103
About this study
Official title: A Randomised, Double-Blind Study Comparing 2 Maintenance Dosing Regimens of Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in Treatment-Seeking Adult Participants With Opioid Use Disorder and High-risk Opioid Use
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.
Read the detailed description
This study consists of an open-label induction phase followed by a double-blind maintenance phase. Each phase is designed to test separate objectives and endpoints.
In the induction phase participants who use opioids via an injection route and/or use high doses of opioids who are in withdrawal will be randomly assigned in a 2:1 ratio to extended-release buprenorphine rapid induction or SoC induction. The rapid induction arm is designed to initiate extended-release buprenorphine treatment following a single dose of transmucosal (TM) buprenorphine, while the SoC induction arm inducts the participant onto extended-release buprenorphine using a TM buprenorphine-containing product for a minimum of 7 days. All participants will receive the first injection of extended-release buprenorphine on Day 1 and the second injection on Day 8.
Participants eligible to continue treatment in the maintenance phase will be randomized at Week 6 prior to Injection 3 in a 1:1 ratio to receive maintenance doses of either 300 mg or 100 mg extended-release buprenorphine every 4 weeks for a total of up to 8 maintenance injections.
- Conditions
- Moderate to Severe Opioid-use Disorder
- Being tested
- Transmucosal Buprenorphine, Extended-release Buprenorphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmucosal BuprenorphineDrug
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 BuprenorphineDrug
Also called RBP-6000, SUBLOCADE
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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). Receives: Drug: Extended-release Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: Week 2
Secondary outcomes (17)
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.
Measured: Weeks 10 to 38
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 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 10 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. Opioid use will be assessed at 15 visits between Weeks 10 and 38.
Measured: Weeks 10 to 38
Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38
Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids.
The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Measured: Weeks 10 to 38
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 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% for the last 5 visits planned for urine drug screen (UDS) and TimeLine Follow Back (TLFB) over Weeks 30 to 38 (inclusive).
Opioid abstinence is defined as a negative UDS result and negative responses to the 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.
Measured: Week 30 to 38
Maintenance Phase: Percentage of Responders for Daily Opioid Use
A responder for daily opioid use is defined as a participant with 20% or less days of opioid use, based on the TimeLine Follow Backs (TLFBs) collected at the last 5 observed visits post randomization. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Measured: Week 30 to 38
Maintenance Phase: Percentage of Visits With Opioid Abstinence Overall
Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids at all assessments between Weeks 2 and 38. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Measured: Week 2 to 38
Maintenance Phase: Percentage of Days Opioids Were Used Overall
For each participant, the percentage of days opioids were used out of days assessed over Weeks 2 to 38 (inclusive), based on the TimeLine Follow Back (TLFB) for the prior week of each visit.
Measured: Week 2 to 38
Maintenance Phase: Percentage of Days Opioids Were Used Via the Injection Route
For participants who use opioids via the injection route for an average of 5 or more days per week in the last 4 weeks prior to Screening, the percentage of days opioids were used via the injection route out of days assessed based on the Timeline Follow Back (TLFB) interview for the prior week of each visit.
Measured: Weeks 10 to 38
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
The average number of times opioids were used per week for a given visit based on the TimeLine Follow Back (TLFB) for the prior week collected at that visit.
Measured: Baseline to Week 38
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
The change in participants' number of times opioids were used per week from randomization baseline to each visit based on the 7 daily TimeLine Follow Back (TLFB) for the prior week collected at that visit.
Measured: Baseline to Week 38
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids.
Measured: Baseline to Week 38
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
The average number of days opioids were used per week out of days assessed, based on the TimeLine Follow Back (TLFB) for the prior week of each visit.
Measured: Baseline to Week 38
Maintenance Phase: Time From DB Randomization to Last Observed Study Visit (Treatment Retention)
Treatment retention is defined as the number of days that participants remained in the treatment from randomization in the Maintenance Phase of the study until the date of the last observed study visit.
The treatment retention since DB randomization is estimated using Kaplan-Meier method. The event is prematurely discontinuing the study prior to Week 38/EOT Visit.
Measured: Up to 288 days after randomization (accounting for out-of-window visits)
Maintenance Phase: Percentage of Participants Who Complete the Last Scheduled Injection
The proportion of randomized participants who completed the last scheduled injection of RBP-6000 at Week 34 were summarized using observed data. Missing data were not applicable for this endpoint.
Measured: Week 34
Induction Phase: Percentage of Participants Retained at 5 Weeks
Percentage of participants retained at 5 weeks after the first dose of TM buprenorphine was estimated using the Kaplan-Meier product limit method.
Measured: 35 days
Induction Phase: Number of Participants With Adverse Events up to Injection 2
These endpoints encompassed all induction attempts and therefore utilized the first dose of transmucosal buprenorphine (TM BUP) for derivations. A treatment-emergent adverse event (TEAE) was defined as an AE having an onset date/time after administration of the first TM BUP dose and before the date/time of Injection 3. TEAEs up to RBP-6000 Injection 2 were TEAEs with a start date/time on or after the first dose of TM BUP and before the date/time of Injection 2.
Measured: Up to approximately 2 weeks
Induction Phase: Number of Participants With Adverse Events Between Injections 2 and 3
These endpoints encompassed all induction attempts and therefore utilized the first dose of transmucosal buprenorphine (TM BUP) for derivations. A treatment-emergent adverse event (TEAE) was defined as an AE having an onset date/time after administration of the first TM BUP dose and before the date/time of Injection 3. TEAEs between RBP-6000 Injections 2 and 3 were TEAEs with a start date/time on or after Injection 2 and before the date/time of Injection 3.
Measured: Approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start26 Oct 2021
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 785 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Director Clinical Development, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995029
- Sponsor's protocol ID
- INDV-6000-401
- Other IDs
- TRANSFORM
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2021
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41405885Shiwach 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.
PubMed 41085986
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind Study Comparing 2 Maintenance Dosing Regimens of Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in Treatment-Seeking Adult Participants With Opioid Use Disorder and High-risk Opioid Use
- ClinicalTrials.gov ID
- NCT04995029
- Acronym / sponsor ID
- INDV-6000-401
- Conditions
- Moderate to Severe Opioid-use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 785 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Posted 25 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of an open-label induction phase followed by a double-blind maintenance phase. Each phase is designed to test separate objectives and endpoints.
In the induction phase participants who use opioids via an injection route and/or use high doses of opioids who are in withdrawal will be randomly assigned in a 2:1 ratio to extended-release buprenorphine rapid induction or SoC induction. The rapid induction arm is designed to initiate extended-release buprenorphine treatment following a single dose of transmucosal (TM) buprenorphine, while the SoC induction arm inducts the participant onto extended-release buprenorphine using a TM buprenorphine-containing product for a minimum of 7 days. All participants will receive the first injection of extended-release buprenorphine on Day 1 and the second injection on Day 8.
Participants eligible to continue treatment in the maintenance phase will be randomized at Week 6 prior to Injection 3 in a 1:1 ratio to receive maintenance doses of either 300 mg or 100 mg extended-release buprenorphine every 4 weeks for a total of up to 8 maintenance injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Induction Phase: Rapid Induction | Experimental | Drug: Transmucosal Buprenorphine, Drug: Extended-release BuprenorphineParticipants 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. |
| Induction Phase: Standard of Care Induction | Experimental | Drug: Transmucosal Buprenorphine, Drug: Extended-release BuprenorphineParticipants 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. |
| Maintenance Phase: Extended-release Buprenorphine 100 mg | Experimental | Drug: Extended-release BuprenorphineParticipants 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). |
| Maintenance Phase: Extended-release Buprenorphine 300 mg | Experimental | Drug: Extended-release BuprenorphineParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transmucosal BuprenorphineTransmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal) | Drug | Induction Phase: Rapid Induction, Induction Phase: Standard of Care Induction |
| Extended-release BuprenorphineAlso: RBP-6000, SUBLOCADEAdministered by subcutaneous injection | Drug | Induction Phase: Rapid Induction, Induction Phase: Standard of Care Induction, Maintenance Phase: Extended-release Buprenorphine 100 mg, Maintenance Phase: Extended-release Buprenorphine 300 mg |
Primary outcome
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38
Time frame: 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.
Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit
Time frame: Week 2
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".
17 secondary outcomes
Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38
Time frame: Weeks 10 to 38
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38
Time frame: Weeks 10 to 38
Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38
Time frame: Weeks 10 to 38
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38
Time frame: Week 30 to 38
Maintenance Phase: Percentage of Responders for Daily Opioid Use
Time frame: Week 30 to 38
Maintenance Phase: Percentage of Visits With Opioid Abstinence Overall
Time frame: Week 2 to 38
Maintenance Phase: Percentage of Days Opioids Were Used Overall
Time frame: Week 2 to 38
Maintenance Phase: Percentage of Days Opioids Were Used Via the Injection Route
Time frame: Weeks 10 to 38
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Time frame: Baseline to Week 38
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Time frame: Baseline to Week 38
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Time frame: Baseline to Week 38
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Time frame: Baseline to Week 38
Maintenance Phase: Time From DB Randomization to Last Observed Study Visit (Treatment Retention)
Time frame: Up to 288 days after randomization (accounting for out-of-window visits)
Maintenance Phase: Percentage of Participants Who Complete the Last Scheduled Injection
Time frame: Week 34
Induction Phase: Percentage of Participants Retained at 5 Weeks
Time frame: 35 days
Induction Phase: Number of Participants With Adverse Events up to Injection 2
Time frame: Up to approximately 2 weeks
Induction Phase: Number of Participants With Adverse Events Between Injections 2 and 3
Time frame: Approximately 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41405885Shiwach 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.
- Results publication: PubMed 41085986Shiwach 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.
- Individual participant dataSharing planned: No
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TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization
Opioid Use Disorder, Opioid Use Disorder, Moderate
RecruitingPhase 2
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Opioid Use Disorder, Opioid Use Disorder, Moderate
Not yet recruiting
Family-Focused Study to Support Medication for Opioid Use Disorder
Opioid Use Disorder, Opioid Use Disorder, Moderate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Director Clinical Development study director
Indivior Inc.
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transmucosal Buprenorphine and Extended-release Buprenorphine in people with Moderate to Severe Opioid-use Disorder, run by Indivior Inc. at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38 (time frame: Weeks 20 to 38). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04995029, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.