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

Association between extended-release buprenorphine adherence and reduced healthcare costs among insured patients with opioid use disorder. (PubMed, Front Public Health) - "To evaluate the relationship between adherence to extended-release buprenorphine (BUP-XR; SUBLOCADE®) and reduced healthcare utilization and medical costs among patients with opioid use disorder (OUD)...The lower adjusted costs observed in Groups 3 and 4 reflected patient disengagement from care, characterized by substantially fewer outpatient services and higher acute care utilization. Sustained BUP-XR adherence reduced costly medical utilization compared to non-adherence to BUP-XR while maintaining adherence to overall MOUD."

HEOR • Journal • Retrospective data • Addiction (Opioid and Alcohol) • Substance Abuse

INDV-6001 Multiple-Dose Pharmacokinetic Study (clinicaltrials.gov) - P2 | N=123 | Completed | Sponsor: Indivior Inc. | Active, not recruiting ➔ Completed

Trial completion • Substance Abuse

COPILOT: Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: University of California, San Francisco

New P4 trial • Substance Abuse

Case Series: Simultaneous Use of Long-Acting Injectable Antipsychotics and Vivitrol or Long-Acting Buprenorphine in Dual Diagnosis Patients with Bipolar Disorder and Substance Use Disorders. (PubMed, Psychopharmacol Bull) - "Medication combinations included paliperidone palmitate with Sublocade (n = 2) and aripiprazole lauroxil with Sublocade (n = 1). This combination approach may be particularly valuable for patients with poor medication adherence. Preliminary findings support the need for controlled research to establish optimal patient selection criteria, medication combinations, and predictors of treatment response."

Journal • Retrospective data • Addiction (Opioid and Alcohol) • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

A systematic approach to develop and characterize a compositionally equivalent buprenorphine in situ forming implant (Sublocade®). (PubMed, J Control Release) - "Sublocade® and reverse-engineered BUP-ISFI had similar in vitro drug release profiles and demonstrated similar pharmacokinetic profile and drug absorption. This study provides valuable insights into PLGA purification, characterization and in vitro/in vivo evaluation of solution-based in situ forming implants, which is essential for the development of generic products."

Journal • Substance Abuse

Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial (clinicaltrials.gov) - P4 | N=12 | Not yet recruiting | Sponsor: Pouya Azar

New P4 trial • Substance Abuse

CHOICE: Combined Injectable Treatment for HIV and OUD (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Rhode Island Hospital | N=40 ➔ 0 | Active, not recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Human Immunodeficiency Virus • Infectious Disease • Substance Abuse

CHOICE: Combined Injectable Treatment for HIV and OUD (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Rhode Island Hospital | Recruiting ➔ Active, not recruiting | Phase classification: P1 ➔ P2 | Trial completion date: Oct 2024 ➔ Feb 2026 | Trial primary completion date: Apr 2024 ➔ Aug 2025

Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Substance Abuse

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