Sublocade (buprenorphine once-monthly depot) / Indivior - LARVOL DELTA

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In brief: New labeling for once-monthly subcutaneous buprenorphine (Sublocade). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Substance Abuse

Injectable Buprenorphine in Prison: a Preference Trial (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Lifespan

New P4 trial • Substance Abuse

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

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

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