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

BIOPIN 101b: iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers (clinicaltrials.gov) - P1 | N=33 | Active, not recruiting | Sponsor: Akyso Therapeutics, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Substance Abuse

BIOPIN 101b: iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Akyso Therapeutics, LLC | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2029 ➔ Dec 2029 | Trial primary completion date: Jun 2027 ➔ Oct 2029

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

Extended-release naltrexone (Vivitrol) augmentation for compulsive sexual behavior disorder: a case report. (PubMed, Ir J Psychol Med) - "This case suggests extended-release naltrexone may be an effective augmentation strategy for CSBD unresponsive to antidepressant pharmacotherapy and psychotherapy. Controlled trials are needed to establish efficacy."

Journal • Behavior Disorders • CNS Disorders • Mental Retardation • Psychiatry • Substance Abuse

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

Enrollment closed

Contingency management for adherence to injectable medication for substance use disorders. (PubMed, J Subst Use Addict Treat) - "CM approaches are a key strategy for improving adherence to life-saving medications for substance use disorders. In this retrospective cohort study, CM implementation was associated with significantly higher rates of medication adherence compared to a cohort who received treatment prior to CM being available. The CM adaptations implemented by the clinic for this naturalistic study may hold promise for future efforts to reduce administrative burdens of CM without sacrificing effectiveness."

Journal • Addiction (Opioid and Alcohol)

Long-Acting Naltrexone Restores Network Connectivity in Subjects With Comorbid Cannabis and Opioid Use Disorder. (PubMed, Addict Biol) - "All participants underwent imaging prior to receiving a therapeutic dose of long-acting intramuscular NTX (Vivitrol), an approved treatment for OUD and AUD but not for CocUD, and again 2 weeks postadministration. A similar FC response to NTX was observed in the comorbid AUD group, whereas little change in FC was observed in comorbid CocUD. These findings, combined with prior evidence that NTX reduces cannabis use by dampening reward, suggest NTX may hold promise as a treatment for CanUD."

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

Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: BioCorRx Pharmaceuticals Inc | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase 1, Open-label, Exploratory, Fixed-sequence, Pharmacokinetic Single Ascending Dose Study of IVL3004 Versus VIVITROL® (Naltrexone) Long-acting Injectable (LAI) in Healthy Subjects (AAN 2026) - "Controlled initial release minimized early burst, reflecting advanced formulation technology. Together with shorter injection-site reaction duration versus Vivitrol®, these PK features support IVL3004 as a safer, more effective long-acting naltrexone option with potential to improve patient adherence and quality of life."

Clinical • P1 data • PK/PD data

Severe Early-Onset Withdrawal Following Intentional Use of Mitragynine Pseudoindoxyl: A Case Report and Emerging Clinical Considerations. (PubMed, Cureus) - "Supportive management with clonidine, hydroxyzine, gabapentin, loperamide, and antiemetics over 72-96 hours led to symptom resolution. Naltrexone, including a Vivitrol injection, was initiated without precipitating withdrawal, and the patient remained abstinent at one-month follow-up, despite a brief noneuphoric lapse. This case highlights MP as an emerging high-potency kratom derivative that poses unique diagnostic and management challenges. Clinicians should recognize its severe withdrawal profile, the limitations of standard toxicology, and the potential role of naltrexone in relapse prevention once an opioid-free interval is established."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Gastrointestinal Disorder • Mood Disorders • Movement Disorders • Pain • Psychiatry • Suicidal Ideation

AMOHI-1: Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 (clinicaltrials.gov) - P2 | N=78 | Terminated | Sponsor: University of Pennsylvania | N=225 ➔ 78 | Recruiting ➔ Terminated; Funding not renewed

Enrollment change • IO biomarker • Trial termination • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Substance Abuse • CD4

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

BIOPIN 101b: iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Akyso Therapeutics, LLC | Trial completion date: Jul 2027 ➔ Mar 2029

Trial completion date • Substance Abuse

Naltrexone in AUD Reward Drinkers (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Dec 2027 ➔ Jul 2028 | Trial primary completion date: Jul 2026 ➔ Jul 2027

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

Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: BioCorRx Pharmaceuticals Inc

New P1 trial

Self-Reported Cognitive Impairments in Office-Based Treatment for Opioid Use Disorder with Buprenorphine or Extended-Release Naltrexone. (PubMed, Subst Use) - "All scales were associated with a range of demographic and clinical variables. Most adults receiving office-based MAT for OUD reported self-perceived cognitive impairment, but neurological comorbidities may also play a role in these perceptions."

Journal • Addiction (Opioid and Alcohol) • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Epilepsy • Psychiatry • Substance Abuse

Lived Experiences of Medication for Opioid Use Disorder: Clients' Perspectives on Formulation and Treatment. (PubMed, Subst Use) - "This study aimed to explore clients' perceptions and experiences of using oral Suboxone and injectable Vivitrol for OUD treatment. Our study provides valuable insights drawn from clients' experiences using oral and injectable MOUD in substance use treatment facilities. The findings will be useful for healthcare providers and policymakers to consider the pros and cons of these medications in substance use treatment settings."

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

Letter: Safety and Tolerability of Injectable Extended-Release Naltrexone for the Management of Alcohol Use Disorder in Advanced Alcohol-Associated Liver Disease-Authors' Reply. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Fibrosis • Hepatology • Immunology • Psychiatry

Influenza A-Induced Acute Liver Injury: A Rare Adverse Effect (ACG 2025) - "The patient's home medications include atorvastatin, carbamazepine, cyclobenzaprine, famotidine, fluoxetine, gabapentin, hydroxyzine, metformin, multivitamin, propranolol, senna, Seroquel, vitamin B1, Vivitrol. Additionally, labs from a month ago showed liver enzymes to be at baseline. These findings along with the IVA infection point towards IAV-induced ALF.Given the potential for ALI, especially in severely ill patients, routine liver enzyme testing is recommended in the management of IAV infection."

Adverse events • Autoimmune Hepatitis • Chronic Kidney Disease • Hepatology • Immunology • Infectious Disease • Inflammation • Influenza • Liver Failure • Metabolic Disorders • Respiratory Diseases

NALTREXONE-ASSOCIATED EOSINOPHILIC PNEUMONIA: WHEN THE CURE BECOMES A PULMONARY CHALLENGE (CHEST 2025) - "A modest troponin rise (0.01 to 0.05 ng/mL) suggested demand ischemia, but normal BNP, absence of edema, and a normal echocardiogram ruled out heart failure.Empiric treatment with azithromycin and ceftriaxone was initiated for presumed pneumonia, and diuretics were administered for pulmonary edema...Extensive infectious and autoimmune testing was negative, supporting a diagnosis of acute eosinophilic pneumonia likely secondary to Vivitrol.The patient received systemic corticosteroids—six days of prednisone followed by two days of IV solumedrol (60 mg TID then BID)—then transitioned to oral prednisone 50 mg with a taper... This case underscores a rare adverse reaction to Vivitrol resulting in acute eosinophilic pneumonia. Although corticosteroid treatment provided initial respiratory improvement, long-term outcomes were compromised by recurrent alcohol use disorder and social instability. Clinicians should remain vigilant for drug-induced hypersensitivity in patients with..."

Addiction (Opioid and Alcohol) • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Congestive Heart Failure • Eosinophilia • Epilepsy • Heart Failure • Immunology • Infectious Disease • Pneumonia • Pulmonary Embolism • Respiratory Diseases

Long-acting naltrexone restores network connectivity in subjects with co-morbid cannabis and opioid use disorder. (PubMed, bioRxiv) - "All participants underwent imaging prior to receiving a therapeutic dose of long-acting intramuscular NTX (Vivitrol ® ), an approved treatment for OUD and AUD but not for CocUD, and again two weeks post-administration. In contrast, little change in FC was observed in co-morbid CocUD. These findings, combined with prior evidence that NTX reduces cannabis use by dampening the experience of reward, suggest NTX may hold promise as a treatment for CanUD."

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

HSC-MS-24-0024: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: The University of Texas Health Science Center, Houston | N=20 ➔ 2 | Trial completion date: Jan 2026 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Dec 2024; Unable to recruit eligible participants and expiration of study medication.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Psychiatry • Schizophrenia • Tobacco Cessation

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. | Trial completion date: May 2025 ➔ Dec 2025 | Trial primary completion date: May 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Multiple Sclerosis

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2 | N=1516 | Active, not recruiting | Sponsor: NYU Langone Health | N=2190 ➔ 1516

Enrollment change • Substance Abuse

BIOPIN 101b: A Phase 1b Study Comparing the Pharmacokinetics and Safety of Low- and High-Dose BIOPIN Naltrexone Implants With Monthly Vivitrol Injections in Healthy Volunteers Over 12 Months (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Drug Delivery Company, LLC DBA Akyso Pharmaceuticals

New P1 trial • Substance Abuse

Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder (clinicaltrials.gov) - P2 | N=3 | Terminated | Sponsor: University of Pennsylvania | N=200 ➔ 3 | Trial completion date: Jan 2027 ➔ Aug 2024 | Not yet recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Aug 2024; Primary funding source has ended.

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