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

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

Prescribing of extended release buprenorphine injection for Medicaid beneficiaries, 2018-2022. (PubMed, Addiction) - "The number of extended release buprenorphine injection prescriptions among US Medicaid beneficiaries treated for opioid use disorder increased from over 4000 prescriptions in 2018 to over 185 000 in 2022 but uptake is much less than observed in other countries over shorter time periods."

Journal • Medicaid • Reimbursement • US reimbursement • Substance Abuse

Dissemination of health content through social networks: YouTube and opioid use disorders. (PubMed, J Subst Use Addict Treat) - "The overall quality, accuracy, and reliability of MOUD and harm reduction related content posted on YouTube is poor. The lack of evidence-based content posted on YouTube reinforces the need for public health expert involvement in disseminating guideline-based content on social media."

Journal • Review • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

INDV-6000-401: Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users (clinicaltrials.gov) - P4 | N=785 | Completed | Sponsor: Indivior Inc. | N=489 ➔ 785 | Active, not recruiting ➔ Completed

Enrollment change • Trial completion • Substance Abuse

Assessing Optimal XRB Initiation Points in Jail (clinicaltrials.gov) - P4 | N=200 | Not yet recruiting | Sponsor: NYU Langone Health | Trial completion date: Jan 2026 ➔ Jun 2026 | Initiation date: Mar 2024 ➔ Jul 2024 | Trial primary completion date: Oct 2025 ➔ Feb 2026

Trial completion date • Trial initiation date • Trial primary completion date • Substance Abuse

Rapid induction of transdermal buprenorphine to subcutaneous extended-release buprenorphine for the treatment of opioid use disorder. (PubMed, Addict Sci Clin Pract) - "This provides preliminary evidence for a rapid induction strategy that may improve tolerability, caregiver burden, and treatment retention as compared to previous induction strategies."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

Surgical removal of extended-release buprenorphine depot due to adverse reactions. (PubMed, Am J Emerg Med) - "Although buprenorphine is a partial agonist with seemingly less precipitated withdrawal and easier initiation than full opioid agonists used for OUD, its use is not benign and understanding of the different extended-release formulations is necessary. We report a case of a patient that received a long-acting buprenorphine formulation (Sublocade®) administered subcutaneously that presented to the emergency department with tachycardia, hyperglycemia, elevated anion gap, and sustained nausea and vomiting refractory to pharmacotherapy requiring surgical removal of the buprenorphine depot for resolution of nausea and vomiting symptoms."

Clinical • Journal • Observational data • Retrospective data • Review • Cardiovascular • Diabetes • Substance Abuse

Epidemiology and Public Health Research Methods (CPDD 2024) - "Exciting results, but what is the ground truth?" He will present about ground truth and the analysis of Reddit data, 3) Maria Parker, Indiana University - "Digital Epidemiology of Prescription Drug References Among Twitter Users." She will present on harnessing multiple natural language processing analyses to explore street and brand name drug-related tweets, 4) Michael Gilbert, Booz Allen Hamilton – "Process and Performance of Machine-Assisted Social Media Research." This project involves using Reddit to understand patients’ experiences tapering off Sublocade, and 5) Meredith Meacham, University of California, San Francisco – "Unsupervised machine learning to identify cannabis reduction strategies in an online community." She uses topic modeling to understand cannabis moderation subreddits. All five presenters will discuss pertinent socially and clinically relevant public health implications about substance use on social media."

Clinical

Recent Trends in the Utilization of Long-Acting Injectable Buprenorphine in Kentucky (CPDD 2024) - "LAI-bup utilization has increased since the product became available. The trend of increasing LAI-bup dispensing intensified starting around January 2021, the same week that a single PDL, explicitly including Sublocade®, was implemented statewide. Given that LAI-bup utilization has increased in general, additional work is needed to understand if the implementation of the PDL had a causal effect on LAI-bup uptake."

Novel Coronavirus Disease

Utilization of long-acting injectable monthly depot buprenorphine for opioid use disorder (OUD) in Kentucky, before and after COVID-19 related buprenorphine access policy changes. (PubMed, J Subst Use Addict Treat) - "LAI-bup access, utilization, and retention increased after several policy changes."

Journal • Addiction (Opioid and Alcohol) • Infectious Disease • Novel Coronavirus Disease • Substance Abuse