buprenorphine sublingual tablets / Generic mfg. - 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

Is There a Difference between those who Require Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS) and Those Who Do Not? (AAP-NCE 2025) - "Out aim was to compare the characteristics of neonates with NOWS who required pharmacological treatment versus those who did not. This is a sub-set analysis of patients who were enrolled in an IRB approved, prospective, non-inferiority, double-blinded, randomized clinical trial (RCT) of clonidine versus morphine sulphate as a primary treatment for NOWS, after parental consent...An equal number of neonates exposed to Methadone required treatment (51% vs 49%)... There were no demographic differences between patients who required pharmacological treatment versus those who did not. Patients exposed to Subutex in-utero, not exposed to poly-substance, and those who received some breast milk feeds were less likely to require pharmacological treatment."

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

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

DEA Telemedicine Rules Further Delayed Until (Nearly) 2026 (National Law Review) - "Those waiting anxiously for the rules expanding the prescribing of buprenorphine via telemedicine and the controlled substance prescribing for patients at the Department of Veterans Affairs to officially go into effect will now have to wait until New Year’s Eve—December 31, 2025....The Buprenorphine and VA Telemedicine Prescribing Rules amended previous regulations to expand the circumstances under which: practitioners registered by DEA are authorized to prescribe schedule III-V controlled substances approved by the FDA for treatment of opioid use disorder via a telemedicine encounter; and; VA practitioners acting within the scope of their VA employment are authorized to prescribe schedule II-IV controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation, if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to conditions."

Commercial • Addiction (Opioid and Alcohol)

MOMs: Medication Treatment for Opioid Use Disorder in Expectant Mothers (clinicaltrials.gov) - P3 | N=140 | Completed | Sponsor: T. John Winhusen, PhD | Active, not recruiting ➔ Completed

Trial completion • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

MOMs-CMA: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (clinicaltrials.gov) - P3 | N=97 | Completed | Sponsor: T. John Winhusen, PhD | Active, not recruiting ➔ Completed

Trial completion • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

MOMs-INO: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study (clinicaltrials.gov) - P3 | N=71 | Completed | Sponsor: T. John Winhusen, PhD | Recruiting ➔ Completed | N=200 ➔ 71

Enrollment change • Trial completion • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Mother/BabyOUD: Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Senthil Sadhasivam | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • Substance Abuse

Mother/BabyOUD: Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Senthil Sadhasivam | N=300 ➔ 600

Enrollment change • Addiction (Opioid and Alcohol) • 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

Identifying facilitators and barriers to the uptake of medication for opioid use disorder in Washington, DC: A community-engaged concept mapping approach. (PubMed, PLoS One) - "This study distinguishes itself from other research on MOUD delivery and barriers by centering on community members and their lived experiences. Findings emphasize the need to expand access to treatment, dismantle stigma associated with substance use and MOUD, and address underlying circumstances that contribute to the profound sense of hopelessness and fear among persons with OUD-all of which will require collective action from consumers, providers, and the public."

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

Idea Exchange: Buprenorphine Formulations: New, Old, and Everything In Between (Presented by Substance Use Disorders Strategies (SUDS) Community) (AAPP 2024) - "The Buprenex injectable buprenorphine was approved in 1985 but it wasn't really until after the approval of Suboxone and Subutex in 2002 that buprenorphine really to become a gold standard treatment option for opioid use disorder. There are a multitude of different buprenorphine formulations that exist, creating a necessary pharmacist role in appropriate use of buprenorphine. This idea exchange will explore various buprenorphine products, highlight similarities and differences, and discuss methods to switch between buprenorphine products."

Substance Abuse

Racial Disparities in Substance Use Treatment and Perinatal Outcomes for Pregnant Women (ASAM 2024) - "There was no significant difference in the rate of Methadone use prior to conception...Specifically, Black women experienced restricted access to key MATs like Subutex and Suboxone, which offer substantial accessibility benefits especially during pregnancy [3]... Of the 485 patients in the study cohort, 125 (26%) self-identified as Black and 360 (74%) as White race. 81% (n=393) of the cohort overall had opioid use disorder (OUD). Rates of all SUDs were similar across groups except for cocaine (p <.01) and amphetamine use disorder (p <.01)."

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

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Adult Cancer Pain, Version 1.2024. (NCCN)

NCCN guideline • Oncology • Pain

Diversion of medications to treat opioid use disorder: Qualitative findings from formerly incarcerated adults in Massachusetts. (PubMed, Int J Drug Policy) - "Formerly incarcerated patients perceived MOUD diversion within jail medication programs as occurring less often than expected and that it can be reduced with appropriate protocols. To help limit medication diversion, patients recommended provision of MOUD upon intake to all individuals with opioid use disorder who need it. Findings have implications for MOUD program adaptation, successful routinization, and diffusion in carceral settings."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

Mother/BabyOUD: Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Senthil Sadhasivam | Trial completion date: Sep 2023 ➔ Dec 2025 | Trial primary completion date: Sep 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • Substance Abuse

MOMs-CMA: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (clinicaltrials.gov) - P3 | N=97 | Active, not recruiting | Sponsor: T. John Winhusen, PhD | Recruiting ➔ Active, not recruiting | N=200 ➔ 97

Enrollment change • Enrollment closed • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

SUBLOCADE Long-term Outcomes (clinicaltrials.gov) - P=N/A | N=1200 | Recruiting | Sponsor: Indivior Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol) • Substance Abuse

Mother/BabyOUD: Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Senthil Sadhasivam | Trial completion date: Jun 2023 ➔ Sep 2023 | Trial primary completion date: Jun 2023 ➔ Sep 2023

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • Substance Abuse

Chordae Tendineae Vegetation in the Setting of Strep Mitis: A Case Report (ATS 2023) - "A 29-year-old female with a PMH of uncontrolled type I DM, chronic hep C, and polysubstance abuse on subutex presented with SOB, fevers, chills, cough, malaise, vomiting, and LE edema...BC positive for Streptococcus Mitis and was initiated on cefazolin with ID consultation for long term antibiotics...PICC removed and completed course of Unasyn and Micafungin...A 29-year-old female with a PMH of uncontrolled type I DM, chronic hep C, and polysubstance abuse on subutex presented with SOB, fevers, chills, cough, malaise, vomiting, and LE edema...BC positive for Streptococcus Mitis and was initiated on cefazolin with ID consultation for long term antibiotics...PICC removed and completed course of Unasyn and Micafungin...Corda tendinea are often secondarily affected by mitral valve prolapse casing tears but have not often been reported to have vegetations directly attached. Though extremely rear, vegetations of the corda tendineae may be present as exemplified by the..."

Clinical • Cardiovascular • Cough • Hepatitis C • Infectious Disease • Inflammation • Pulmonary Embolism • Respiratory Diseases

The switching process from buprenorphine sublingual tablets to the monthly buprenorphine subcutaneous depot injection in opioid dependent patients. (PubMed, Addict Biol) - "In the first weeks after the medication switch, patients experience potentially distressing symptoms, which, however, seem to diminish over time. Close supervision and comprehensive patient education on possible burdens of the medication switch to the BUP-XR might prevent unfavourable treatment courses and premature therapy dropouts."

Journal • Addiction (Opioid and Alcohol)

Opioid Use Disorder Treatment in the Pregnant Patient (APA 2023) - "This patient was receiving Subutex (buprenorphine) to treat her opioid use disorder, however after learning she was pregnant, her obstetrician recommended she switch to suboxone (buprenorphine and naloxone). This revelation initiates a new treatment option for pregnant patients to consider. For this patient, she communicated that she felt empowered to be able to participate in her treatment plan and continue her Subutex treatment."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Obstetrics • Psychiatry • Substance Abuse

SUBLOCADE Long-term Outcomes (clinicaltrials.gov) - P=N/A | N=1200 | Not yet recruiting | Sponsor: Indivior Inc.

New trial • Addiction (Opioid and Alcohol) • Substance Abuse

MOMs: Medication Treatment for Opioid Use Disorder in Expectant Mothers (clinicaltrials.gov) - P3 | N=140 | Active, not recruiting | Sponsor: T. John Winhusen, PhD | Recruiting ➔ Active, not recruiting | N=200 ➔ 140

Enrollment change • Enrollment closed • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse