Vivitrol (naltrexone extended-release injectable suspension) / Alkermes - LARVOL DELTA

Naltrexone in AUD Reward Drinkers (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Nov 2026 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Jul 2026

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

Open Label Comparison of Injectable Buprenorphine ( Brixadi®) and Naltrexone (Vivitrol®) for Opioid Use Disorder (clinicaltrials.gov) - P2 | N=3 | Terminated | Sponsor: University of Pennsylvania | N=60 ➔ 3 | Trial completion date: Jul 2028 ➔ Aug 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2028 ➔ Aug 2024; Primary funding source has ended.

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

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025 (PRNewswire) - "'This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia...LYBALVI: Revenues for the fourth quarter were $77.0 million. Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023...ARISTADA: Revenues for the fourth quarter were $96.6 million. Fourth quarter revenues grew 16% compared to the fourth quarter of 2023...VIVITROL: Revenues for the fourth quarter were $134.1 million. Fourth quarter revenues grew 31% compared to the fourth quarter of 2023."

Commercial • New P2 trial • P2 data • Bipolar Disorder • CNS Disorders • Narcolepsy • Schizophrenia • Sleep Disorder

Vivitrol Treatment for Cannabis Use Disorder (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Centre for Addiction and Mental Health | N=10 ➔ 1 | Unknown status ➔ Terminated; Funder contract terminated

Enrollment change • Trial termination • Substance Abuse

Social Network Barriers to Extended-Release Naltrexone Within Rural Appalachia: Perspectives from Justice-Involved Clients and Clinicians. (PubMed, Subst Use Misuse) - "Extended-release naltrexone (XR-NTX, Vivitrol®) is an effective, but underutilized, evidence-based treatment for people with opioid use disorder (POUD) who are incarcerated...In concordance with clinicians, POUDs received high levels of emotional support, but lacked instrumental, financial, and treatment support from networks. The network characteristics of Appalachian POUDs recently released from prison create challenges associated with recovery, which may be addressed through network and educational interventions."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

GASTROINTESTINAL AND LIVER ADVERSE EFFECTS OF MEDICAL TREATMENTS OF ALCOHOL USE DISORDER: A PHARMACOVIGILANCE ANALYSIS OF THE FDA ADVERSE EVENT REPORTING SYSTEM (FAERS) DATABASE (AASLD 2024) - "The drugs identified were disulfiram, acamprosate, oral naltrexone, and intramuscular naltrexone (Vivitrol). Naltrexone had overall better gastrointestinal and liver safety profile compared to disulfiram and acamprosate, with intramuscular naltrexone showing lower side effects than oral naltrexone. Disulfiram has the highest risk of liver toxicity followed by acamprosate."

Adverse events • Addiction (Opioid and Alcohol) • Gastrointestinal Disorder • Hepatology • Liver Failure • Pain

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects. (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Inventage Lab., Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol)

Treatment Journey and Healthcare Resource Use Among Patients With Alcohol Use Disorder Who Initiated Extended-Release Naltrexone: An Analysis of Veterans Affairs Data. (PubMed, Subst Use) - "Of those who received other subsequent medications for AUD, 38.6% (acamprosate) to 47.8% (disulfiram) re-initiated XR-NTX...This finding demonstrates a possible transition from acute, inpatient treatment to long-term, outpatient care that may reflect a reduction in disease severity. Additional research is warranted."

Journal • Addiction (Opioid and Alcohol)

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects. (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Inventage Lab., Inc. | N=30 ➔ 40 | Trial completion date: Mar 2024 ➔ May 2025 | Trial primary completion date: Nov 2023 ➔ May 2025

Enrollment change • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: National Institute on Drug Abuse (NIDA) | Not yet recruiting ➔ Recruiting

Enrollment open

AMOHI-1: Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Substance Abuse • CD4

HSC-MS-24-0024: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: The University of Texas Health Science Center, Houston | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia • Tobacco Cessation

A case of naltrexone-induced acute eosinophilic pneumonia. (PubMed, BMJ Case Rep) - "He presented with 4 days of shortness of breath that started hours after taking injectable naltrexone (Vivitrol). A 3-week post-discharge follow-up chest radiograph confirmed the full resolution of pulmonary infiltrates.Naltrexone-induced AEP is rare, with only six other cases reported in the literature. Careful history taking and prompt evaluation for AEP are important given the potential for rapid progression to acute hypoxic respiratory failure and the excellent response to steroid treatment."

Journal • Addiction (Opioid and Alcohol) • Cough • Critical care • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: The University of Texas Health Science Center, Houston

New P1 trial • CNS Disorders • Psychiatry • Schizophrenia • Tobacco Cessation

Blood pressure response to extended-release naltrexone in heroin and prescription opioid users and its implications for cardiovascular morbidity. (PubMed, J Addict Dis) - "Distinguishing between heroin and prescription opioid users could shed light on the unique clinical and pharmacological profiles of opioid drugs, particularly regarding their cardiovascular safety. This information can be useful in developing personalized therapeutic strategies based on the route of opioid administration."

Journal • Cardiovascular • CNS Disorders • Hypertension • Metabolic Disorders • Psychiatry • Substance Abuse

Attitudes toward extended-release naltrexone treatment for opioid use disorder among African Americans. (PubMed, Drug Alcohol Depend) - "Study findings suggest that African Americans who use opioids may have more favorable attitudes toward XR-NTX than other medications for OUD (e.g., methadone), which tend to be highly stigmatized. These data uniquely contribute to the literature by capturing the voices of African Americans who use opioids, a group with high rates of opioid-related deaths."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep (clinicaltrials.gov) - P3 | N=8 | Completed | Sponsor: Baylor College of Medicine | Enrolling by invitation ➔ Completed | N=14 ➔ 8 | Trial completion date: Aug 2025 ➔ Jan 2024 | Trial primary completion date: Aug 2025 ➔ Jan 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults (clinicaltrials.gov) - P4 | N=796 | Recruiting | Sponsor: NYU Langone Health | N=301 ➔ 796 | Trial completion date: Apr 2025 ➔ Dec 2024 | Trial primary completion date: Oct 2024 ➔ Jun 2024

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

Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: National Institute on Drug Abuse (NIDA)

New P3 trial

Naltrexone in AUD Reward Drinkers (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Nov 2024 ➔ Nov 2025

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

Perioperative Management in a Patient Receiving Extended-Release Naltrexone (ASA 2023) - "Extended-release intramuscular naltrexone (Vivitrol®) is an opioid receptor antagonist used for treating opioid use disorder and alcohol use disorder (AUD). Our analgesic strategy included an opioid-free, multimodal analgesic regimen including preemptive analgesia, ketamine, thoracic epidural, and non-opioid analgesics. The postoperative course was uncomplicated, illustrating the viability of this analgesic regimen and the value of perioperative pain programs."

Clinical • Addiction (Opioid and Alcohol) • Oncology • Pain • Substance Abuse

The first nonclinical pharmacokinetic and safety report of IVL3004, a novel long-acting injectable naltrexone formulation (ECNP 2023) - "Based on this, naltrexone-loaded LAI was developed already (Vivitrol®), however, more precisely controlled drug-release profile is still needed because of its notorious initial burst. IVL3004 formulation was decided to be developed for the human clinical study based on these nonclinical data. Phase I IND was approved in early 2023 and planned to start within this year."

Clinical • PK/PD data • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry

Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV (clinicaltrials.gov) - P=N/A | N=190 | Completed | Sponsor: MetroHealth Medical Center | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Substance Abuse • CD14

Comparing outcomes of extended-release naltrexone in adolescents and young adults with opioid use disorder. (PubMed, J Subst Use Addict Treat) - "Results indicate that adolescents respond favorably to XR-NTX relative to TAU for treatment of OUD, demonstrating similar outcomes to young adults."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

Drugs for opioid use disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

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