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

NCT05382091 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-23

No results posted yet for this study

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

Interventions

DRUG

naltrexone implant

3.6 g per implant set each containing 60% naltrexone

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University at Buffalo

    collaborator OTHER

  • Go Medical Industries Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Adam Bisaga, MD · New York State Psychiatric Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2028-07-15
Completion
2029-07-15
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382091 on ClinicalTrials.gov