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

Sponsor
Go Medical Industries Pty Ltd
Study ID
NCT05382091
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • naltrexone implant — DRUG
    3.6 g per implant set each containing 60% naltrexone

Study Details

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.

Key Dates

First listed
May 19, 2022
Start date
Jul 15, 2026
Status verified
Feb 2026
Primary completion
Jul 15, 2028
Completion
Jul 15, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OLANI (naltrexone implant)
    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.

Primary Outcome Measure

Treatment Emergent Adverse Events (TEAEs) [ Time Frame: time from from placement of first implant set until end of study at 60 weeks. ]

Related Studies