A Phase II Study of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
Status:
Not yet recruiting
Trial end date:
2025-07-15
Target enrollment:
Participant gender:
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
a second set of implants after 13-24 weeks.
Phase:
Phase 2
Details
Lead Sponsor:
Go Medical Industries Pty Ltd
Collaborators:
Columbia University National Institute on Drug Abuse (NIDA) New York State Psychiatric Institute The Emmes Company, LLC University at Buffalo