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

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

Evaluating the SUBLOCADE Treatment Exit Strategy (clinicaltrials.gov) - P=N/A | N=25 | Active, not recruiting | Sponsor: Indivior Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Substance Abuse

Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations (clinicaltrials.gov) - P4 | N=132 | Completed | Sponsor: Indivior Inc. | N=88 ➔ 132

Enrollment change • Substance Abuse

Experiences of patients and healthcare professionals within a Sublocade LAI buprenorphine medication assisted treatment program for opioid use disorder A qualitative study (ASHP 2024) - No abstract available

Clinical • Addiction (Opioid and Alcohol) • Substance Abuse

24-Hour Induction of Transdermal Buprenorphine to Buprenorphine Extended-Release. (PubMed, J Psychoactive Drugs) - "Here, we present two inpatients with active unregulated fentanyl use that were successfully initiated on buprenorphine extended-release with a novel 24-h transdermal buprenorphine protocol without precipitating withdrawal. This protocol may represent a substantial improvement in the practical feasibility of initiating buprenorphine for patients and providers, although further study is required to confirm efficacy and tolerability."

Journal • Substance Abuse

A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative Injection Locations in Adult Participants with Opioid Use Disorder. (PubMed, Clin Drug Investig) - P4 | "These pharmacokinetic and safety findings support BUP-XR injection into the upper arm, thigh, and buttocks."

Journal • Addiction (Opioid and Alcohol) • Dermatology • Pain • Substance Abuse

INDV-6001 Multiple-Dose Pharmacokinetic Study (clinicaltrials.gov) - P2 | N=122 | Recruiting | Sponsor: Indivior Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Evaluating the SUBLOCADE Treatment Exit Strategy (clinicaltrials.gov) - P=N/A | N=25 | Recruiting | Sponsor: Indivior Inc. | N=50 ➔ 25 | Trial completion date: Sep 2024 ➔ May 2025 | Trial primary completion date: Sep 2024 ➔ May 2025

Enrollment change • Trial completion date • Trial primary completion date • Substance Abuse

Trends in injectable buprenorphine prescribing in Canada: A descriptive analysis in five Canadian Provinces. (PubMed, Drug Alcohol Depend) - "Uptake of BUP-ER varied geographically since being approved by Health Canada. More rapid uptake in rural areas is reassuring and suggests that this form of OAT may be supporting treatment access to those with barriers to more traditional treatment formulations."

Journal • Substance Abuse

BOPAT: Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Laura Fanucchi | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Aug 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Infectious Disease • Substance Abuse

Assessing Optimal XRB Initiation Points in Jail (clinicaltrials.gov) - P4 | N=200 | Not yet recruiting | Sponsor: NYU Langone Health | Trial completion date: Jun 2026 ➔ Oct 2026 | Trial primary completion date: Feb 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Substance Abuse