Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons

NCT05382091 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: GM00204UH3DA047720-03240359
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment. All participants will be treated in an open label manner. No randomization will occur. The OLANI is a long-acting biodegradable form of naltrexone which is implanted in the abdominal region. It is hypothesized that the OLANI will produce blood levels sufficient to block the effects of opioids for an extended period allowing patients to engage in psychosocial treatment and recovery over the long term. After the initial set of implants, participants will be offered 3 sets of single implants 13 weeks, each with an acceptable window of 12-16 weeks after the previous dose.

Conditions

Opioid Use Disorder

Keywords

naltrexone; opioids; OLANI implant; opioid use disorder; opioid dependence; opioid receptor antagonist

Outcome Measures

Primary Outcomes (9)

• Treatment Emergent Adverse Events (TEAEs)

  Incidence and Severity of TEAEs

  time from from placement of first implant set until end of study at 60 weeks.

• Adverse Events of Special Interest (AESI)

  Incidence of AESIs related to the surgical procedure and local reaction to the implant over time

  time from from placement of first implant set until end of study at 60 weeks.

• Deaths

  Incidence of study deaths

  time from from placement of first implant set until end of study at 60 weeks.

• Serious Adverse Events (SAEs)

  Incidence of SAEs

  time from from placement of first implant set until end of study at 60 weeks.

• Adverse events (AEs) causing study discontinuation

  AEs that lead to study discontinuation

  time from from placement of first implant set until end of study at 60 weeks.

• Opioid overdose events

  Incidence of opioid overdose events

  time from from placement of first implant set until end of study at 60 weeks.

• Laboratory abnormalities

  Incidence and Severity of lab abnormalities

  time from from placement of first implant set until end of study at 60 weeks.

• Suicidality

  incidence of suicidal ideation and suicidal behavior captured with the Columbia-Suicide Severity Rating Scale (C-SSRS)

  time from from placement of first implant set until end of study at 60 weeks.

• Concomitant medications

  Proportion of participants who initiate concomitant medications

  time from from placement of first implant set until end of study at 60 weeks.

Secondary Outcomes (20)

• AUC0-t of naltrexone

  collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days until next implant procedure. PK sampling is reduced to every 28 days after 12 weeks if the next implant procedure is not completed.

• AUC0-t of 6-beta-naltrexol

  collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days until next implant procedure. PK sampling is reduced to every 28 days after 12 weeks if the next implant procedure is not completed.

• AUC0-infinity of naltrexone

  collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days until next implant procedure. PK sampling is reduced to every 28 days after 12 weeks if the next implant procedure is not completed.

• AUC0-infinity of 6-beta-naltrexol

  collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days until next implant procedure. PK sampling is reduced to every 28 days after 12 weeks if the next implant procedure is not completed.

• Cmax of naltrexone

  collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days until next implant procedure. PK sampling is reduced to every 28 days after 12 weeks if the next implant procedure is not completed.

Study Arms (1)

OLANI (naltrexone implant)

EXPERIMENTAL

2 OLANI implants containing 60% naltrexone (3.6 g total NXT) administered at Day 0 with repeat dosing of a single implant at Week 13 (within a window of 12-16 weeks). The repeat single dosing may be repeated 3 times in total.

Drug: naltrexone implant

Interventions

naltrexone implant DRUG

3.6 g per implant set each containing 60% naltrexone

Also known as: OLANI, O'Neil Long Acting Naltrexone Implant

OLANI (naltrexone implant)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All genders between 18 and 65 (inclusive) years old
• Meet criteria for a current (within the previous 12-months) DSM-5 diagnosis of OUD at screening, and voluntarily seeking relapse-prevention treatment with NTX implant
• Completed opioid withdrawal as demonstrated by a negative naloxone challenge test (i.e., has tolerated naloxone 0.8 mg)
• Individuals currently treated with NTX will be eligible to receive the implant at the end of the dosing interval of either Vivitrol or oral NTX
• Have no medical or psychiatric contraindications to treatment either with NTX or with the OLANI, as determined by the site clinician and based on medical history and current health status
• Able to sufficiently speak and understand English and understand study procedures
• Able and willing to provide written informed consent
• Able and willing to provide detailed contact information for both self and for close contact(s) on the locator form
• Able and willing to comply with the requirements and procedures of the protocol, including tolerating a minor surgical procedure with local anesthetic for placement of the implant sets into the subcutaneous tissue of the abdomen
• Have an initial weight between 45.3 and 130 kg (inclusive) or have a BMI of 18.5 to 35.0 (inclusive)
• For female participants of childbearing potential, a willingness to practice an effective method of birth control for the duration of participation in the study. Acceptable methods of birth control are specified on the data collection form and in the Manual of Procedures (MOP), and methods other than those specified are not permitted, except in combination with a study-acceptable method; and willingness to complete urine pregnancy testing to confirm non-pregnant status, as per the study schedule and as requested by the site clinician.

You may not qualify if:

• Has a condition, disease state, previous medical history, or observed abnormality(ies) (including physical examination, electrocardiogram \[ECG\], laboratory evaluation, or urinalysis finding) identified during screening that, in the opinion of the site clinician, would preclude safe participation in the study, would affect the ability of the participant to adhere to the protocol, or would interfere with the study assessments, including, but not limited to the following:
• A significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable using protocol-allowed medication(s) for the 30 days immediately preceding the proposed administration of OLANI
• Has had significant suicidal ideation or behavior within the past year
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value more than three times the upper limit of normal, or a different indicator of clinically significant liver cirrhosis (e.g., bilirubin and albumin will also be assessed)
• Has a condition (e.g., chronic pain) that requires ongoing treatment with opiate based medication
• Has any contraindicated medical condition per the approved labelling for NTX containing products
• Has physiological dependence on alcohol and/or sedative-hypnotics that require medical detoxification
• If female, is currently pregnant or breastfeeding, is planning to conceive during the period of study engagement, has a positive blood pregnancy test, or is unwilling to practice effective contraception during study participation
• Has received a NTX implant in the last 12 months
• Has a known hypersensitivity to NTX
• Is not able to provide blood samples due to extensive vein damage
• Has a known hypersensitivity to polylactic acid based materials, including disposable sutures or implants
• Has a known hypersensitivity to local anesthesia
• Is prone to skin rashes, skin irritation, or has a diagnosed or observed skin condition (e.g., recurrent eczema)
• Is tattooed in the proposed implantation area or demonstrates any abnormal skin tissue in the proposed implantation area

Sponsors & Collaborators

• New York State Psychiatric Institute: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Columbia University: collaborator
• The Emmes Company, LLC: collaborator
• University at Buffalo: collaborator
• Go Medical Industries Pty Ltd: lead

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Adam Bisaga, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share