Sublocade (buprenorphine once-monthly depot)
/ Indivior
- LARVOL DELTA
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October 17, 2025
SUBLOCADE Long-term Outcomes
(clinicaltrials.gov)
- P=N/A | N=480 | Completed | Sponsor: Indivior Inc. | Active, not recruiting ➔ Completed | N=1200 ➔ 480
Enrollment change • Trial completion • Addiction (Opioid and Alcohol) • Substance Abuse
August 20, 2025
Sublocade(Buprenorphine)DepotContributingtoAcuteHypoxicRespiratoryFailure
(ASA 2025)
- "A 32 year old male with a past medical history significant for opiate and methamphetamine use presented with acute hypoxic respiratory failure following administration of 300mg of sublocade he subsequently developed nausea, vomiting, difficulty urinating and shortness of breath. The sublocade depot was removed surgically with immediate improvement in urinary retention and hypoxic repiratory failure. This case demonstrates the risks of sublocade injections in patient with concomitant respiratory disease."
Cardiovascular • Infectious Disease • Pneumonia • Respiratory Diseases • Ventricular Tachycardia
September 19, 2025
INDV-6001 Multiple-Dose Pharmacokinetic Study
(clinicaltrials.gov)
- P2 | N=122 | Active, not recruiting | Sponsor: Indivior Inc. | Recruiting ➔ Active, not recruiting
Enrollment closed • Substance Abuse
September 11, 2025
Monitoring and management of injection site reactions in patients receiving subcutaneous buprenorphine (Sublocade): two case reports and literature review.
(PubMed, J Addict Dis)
- "The first case was managed conservatively with cold compresses, topical hydrocortisone, and ibuprofen, resulting in symptom resolution. While ISRs associated with Sublocade are common, most are manageable with conservative interventions. Emphasizing patient education, proper injection techniques, and site rotation is essential to prevent ISRs, minimize their severity, and enhance treatment outcomes in patients with OUD."
Journal • Dermatology • Pain • Substance Abuse
September 11, 2025
Assessing Optimal XRB Initiation Points in Jail
(clinicaltrials.gov)
- P4 | N=200 | Recruiting | Sponsor: NYU Langone Health | Not yet recruiting ➔ Recruiting
Enrollment open • Substance Abuse
July 29, 2025
Extended-release injectable buprenorphine for the treatment of opioid use disorder among individuals at high risk of overdose: The FASTER-BUP udy.
(PubMed, Drug Alcohol Depend)
- "While XR-BUP was well tolerated in this sample of people with OUD at high risk of overdose, six-month retention rates were low and most continued to use illicit opioids while on treatment."
Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse
July 12, 2025
Injectable buprenorphine during transition out of prison: A pilot partially randomized preference trial protocol.
(PubMed, Contemp Clin Trials)
- "This study explores differences in XR-B formulations during the high-risk time of transition out of prison. It combines a hybrid implementation science and preference trial design-two methodologies that can help address the specific challenges of research in carceral environments. By understanding implementation of XR-B in a prison setting, findings can provide valuable insights to guide other facilities in adopting this life-saving treatment."
Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse
July 08, 2025
Buprenorphine Extended-Release Injection for Subcutaneous Use (Sublocade®): An Overview for Psychiatric Advanced Practice Nurses.
(PubMed, J Psychosoc Nurs Ment Health Serv)
- "The current article provides a brief overview for psychiatric advanced practice nurses of buprenorphine extended-release injection for subcutaneous use (Sublocade®) for the treatment of moderate to severe opioid use disorder. [Journal of Psychosocial Nursing and Mental Health Services, 63(7), 7-11.]."
Journal • Review • Psychiatry • Substance Abuse
July 07, 2025
SUBLOCADE Long-term Outcomes
(clinicaltrials.gov)
- P=N/A | N=1200 | Active, not recruiting | Sponsor: Indivior Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2027 ➔ Aug 2025 | Trial primary completion date: Aug 2027 ➔ Aug 2025
Enrollment closed • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • Substance Abuse
June 20, 2025
Extended-release buprenorphine treatment for opioid use disorder: A mixed-methods study of response and experience.
(PubMed, Addiction)
- "There appears to be variation in response and experience of extended-release buprenorphine during the first six months of treatment, depending on substance use and physical health. This highlights the need for tailored treatment plans based on differing individual needs."
Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Mood Disorders • Psychiatry • Substance Abuse
June 09, 2025
Digital Biomarker Detection of Craving Among Individuals in Treatment for Opioid Use Disorder with Sublocade (BUP-XR)
(CPDD 2025)
- "A digital detection tool showed distinct craving trajectory patterns in individuals receiving BUP-XR treatment. Future research should assess relationship to clinical outcomes in 1 larger samples."
Biomarker • Clinical • Addiction (Opioid and Alcohol) • Substance Abuse
June 09, 2025
Clinical Outcomes in Adults with Opioid Use Disorder: Long-Term Treatment with Long-Acting Injectable Buprenorphine Under Real-World Conditions
(CPDD 2025)
- "Financial Support : Indivior Aims: BUP-XR is an extended-release, long-acting injectable buprenorphine formulation indicated for the treatment of moderate/severe opioid use disorder (OUD) (United States/Canada: SUBLOCADE®) and opioid dependence (Australia/European Union: SUBLOCADE/SUBUTEX®). This study incorporates clinical and patient-reported outcome data and will provide additional insight into the real-world trajectories and treatment resposnses observed in patients treated with BUP-XR."
Clinical • Clinical data • Real-world • Real-world evidence • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Substance Abuse
June 04, 2025
Evaluating the SUBLOCADE Treatment Exit Strategy
(clinicaltrials.gov)
- P=N/A | N=12 | Completed | Sponsor: Indivior Inc. | Active, not recruiting ➔ Completed | N=25 ➔ 12
Enrollment change • Trial completion • Substance Abuse
June 03, 2025
Transition to Extended-release Buprenorphine Injectable Within Seven Days for Opioid Use Disorder Treatment: A Scoping Narrative.
(PubMed, J Addict Med)
- "Limited descriptive studies suggest transitioning to Bup-XR-S within 7 days appears feasible, well-tolerated, and supports treatment adherence. Following labelled dosing, Bup-LA-B transitions within 24 hours were effective and well-tolerated. While these approaches may help initiate opioid agonist therapy in high-risk populations and mitigate overdose risks, further research is needed to confirm effectiveness and impact on retention."
Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain • Psychiatry • Substance Abuse
May 26, 2025
The Impact of Social Determinants of Health on Opioid Use Disorder and Overdose: An Umbrella Review of Meta-Analyses and Reviews
(APA 2025)
- "There were a total of 2386 publications published before June 28th, 2024 that used opioid-related terms (e.g., opioid, opiate, heroin, OUD, substance use, Methadone, Naloxone, Buprenorphine, Naltrexone, Sublocade, overdose, near miss) and also indicated the synthesis of previous literature (meta-analysis, systematic review, scoping review) within the title. The current umbrella review reveals the need to continue efforts to conduct and synthesize original research on the impact of SDoH on OUD and overdose."
Review • Addiction (Opioid and Alcohol) • Infectious Disease • Novel Coronavirus Disease • Substance Abuse
May 14, 2025
BOPAT: Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
(clinicaltrials.gov)
- P2 | N=71 | Completed | Sponsor: Laura Fanucchi | Trial completion date: Aug 2025 ➔ Mar 2025 | Recruiting ➔ Completed
Trial completion • Trial completion date • Infectious Disease • Substance Abuse
May 07, 2025
Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
(clinicaltrials.gov)
- P4 | N=675 | Completed | Sponsor: NYU Langone Health | Recruiting ➔ Completed
Trial completion • Substance Abuse
April 29, 2025
Monthly buprenorphine depot injection (SUBLOCADE®) for opioid use disorder during pregnancy.
(PubMed, Am J Addict)
- "This study addresses a lack of knowledge of treatment of pregnant individuals with OUD and draws on relevant experience from prescribers treating patients with monthly BUP-XR during pregnancy and postpartum. These data support consideration of implementing BUP-XR as part of evidence-based practice that prioritizes OUD treatment access, patient stability, and patient choice during the perinatal period. Three sources of data illustrate that the use of monthly BUP-XR during pregnancy has demonstrated no increased risk and is consistent with the established buprenorphine safety profile."
Journal • Addiction (Opioid and Alcohol) • Obstetrics • Substance Abuse
April 27, 2025
Social Listening for Patient Experiences With Stopping Extended-Release Buprenorphine: Content Analysis of Reddit Messages.
(PubMed, J Med Internet Res)
- "There was nuanced discussion of treatment cessation using BUP-XR on Reddit, with individuals describing detailed courses of treatment and treatment experiences. Few records mentioned opioid withdrawal, and when discussed, withdrawal experiences during cessation of BUP-XR were generally described as less intense than withdrawal experiences with other drugs. These results suggest that social media, such as Reddit, can be leveraged to explore perspectives on treatment and recovery among individuals with opioid use disorder. Overall, this study provides insights into real-world patient experiences with cessation of BUP-XR and is consistent with prior case series; however, more research is needed to understand the course of opioid use disorder following cessation of BUP-XR as well as other MOUD."
Journal • Substance Abuse
April 22, 2025
Assessing Optimal XRB Initiation Points in Jail
(clinicaltrials.gov)
- P4 | N=200 | Not yet recruiting | Sponsor: NYU Langone Health | Trial completion date: Oct 2026 ➔ Mar 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026
Trial completion date • Trial primary completion date • Substance Abuse
April 21, 2025
In brief: New labeling for once-monthly subcutaneous buprenorphine (Sublocade).
(PubMed, Med Lett Drugs Ther)
- No abstract available
Journal • Substance Abuse
March 18, 2025
Injectable Buprenorphine in Prison: a Preference Trial
(clinicaltrials.gov)
- P4 | N=60 | Not yet recruiting | Sponsor: Lifespan
New P4 trial • Substance Abuse
February 24, 2025
Indivior Announces FDA Approval of Label Changes for SUBLOCADE (buprenorphine extended-release) Injection
(PRNewswire)
- "Indivior PLC...today announced that the U.S. Food and Drug Administration (FDA) has approved label changes for SUBLOCADE including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder...Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability; SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration."
FDA approval • CNS Disorders
February 16, 2025
Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder
(clinicaltrials.gov)
- P2 | N=40 | Suspended | Sponsor: Frances R Levin | Trial completion date: Jan 2025 ➔ Jun 2025 | Trial primary completion date: Jan 2025 ➔ Jun 2025
Trial completion date • Trial primary completion date • Substance Abuse
January 31, 2025
A Naturalistic Study of Individuals Involved in the Justice System Who Experienced Both Formulations of Extended-release Buprenorphine.
(PubMed, J Addict Med)
- "Patients may prefer Brixadi to Sublocade because of injection site pain/discomfort. This could be mitigated with topical or subcutaneous anesthetics. Findings are mixed with respect to the effect of the medications on cravings, withdrawal symptoms, and the medication wearing off too soon. To address feelings of the medication wearing off too soon, patients could be given additional weekly doses of Brixadi (for patients on monthly doses of Brixadi) or supplemental sublingual buprenorphine (for patients on either Brixadi or Sublocade)."
Journal • Anesthesia • Pain
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