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Monthly shot study tests better doses for opioid addiction

NCT ID NCT04995029

Disease control Sponsor: Indivior Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different doses (100 mg vs 300 mg) of a monthly buprenorphine injection in 785 adults with moderate to severe opioid use disorder. The goal was to see which dose helped people stay in treatment and reduce opioid use. The study also compared a faster versus standard way to start the medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

785 people

The number who actually took part.

Started

Oct 2021

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Has signed the informed consent form (ICF) and is able and willing to comply with the requirements and restrictions listed therein. 2. Is 18 years of age or older at the time of signing the ICF. 3. Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD). 4. Has a history of OUD as defined by documented medical history of OUD for at least 90 days immediately prior to providing informed consent. 5. 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. 6. Is seeking medication for the treatment of OUD. 7. 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. 8. Agrees not to use buprenorphine-containing products other than those administered as part of study treatment for the duration of the treatment period. 9. 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: 1. Has current diagnosis, other than OUD, requiring chronic opioid treatment. 2. Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders. 3. Meets DSM-5 criteria for severe alcohol use disorder. 4. 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. 5. 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. 6. Has abdominal area unsuitable for subcutaneous injections (e.g., nodules, scarring, lesions, excessive pigment). 7. 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. 8. 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. 9. Has any other active medical condition, organ disease or concurrent medication or treatment that may either compromise participant safety or interfere with study endpoints. 10. 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. 11. Has known allergy or hypersensitivity to buprenorphine or any component of the ATRIGEL Delivery System. 12. 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. 13. 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. 14. Is undergoing concurrent treatment with medications contraindicated for use with buprenorphine as per local prescribing information. 15. Has any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures. 16. Is under court order requiring treatment for OUD. 17. 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.

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate to severe opioid use disorder

Contacts and locations

Locations

  • Accel Research Sites- Lakeland Clinical Research Unit

    Lakeland, Florida, 33803, United States

  • Alpine Research Organization

    Clinton, Utah, 84015, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Asclepes Research Centers

    Panorama City, California, 91402, United States

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744, United States

  • Behavioral Clinical Research, Inc

    Miami Lakes, Florida, 33016, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carolina Medical Research, LLC

    Clinton, South Carolina, 29325, United States

  • Carolina Medical Research, LLC

    Greenville, South Carolina, 29607, United States

  • Center For Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H4, Canada

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801, United States

  • Clinical Research Associates of Central PA

    Altoona, Pennsylvania, 16602, United States

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845, United States

  • David Weitzman

    Myrtle Beach, South Carolina, 29577, United States

  • Duke Hospital

    Durham, North Carolina, 27705, United States

  • Hassman Research Institute

    Berlin, New Jersey, 08009, United States

  • ICAHN School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Innovative Clinical Research Inc.

    North Miami, Florida, 33161, United States

  • Insite Clinical Research

    DeSoto, Texas, 75115, United States

  • Midwest Clinical Research

    Dayton, Ohio, 45417, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Pahl Pharmaceutical Professionals LLC

    Oklahoma City, Oklahoma, 73112, United States

  • Prisma Health ITOR Research Pharmacy

    Greenville, South Carolina, 29605, United States

  • Progressive Clinical Research

    Bountiful, Utah, 84010, United States

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112, United States

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607, United States

  • Today Clinical Research

    Oklahoma City, Oklahoma, 73120, United States

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118, United States

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