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.
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
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
Single group
naltrexone implant
Drug3.6 g per implant set each containing 60% naltrexone
Treatment Emergent Adverse Events (TEAEs)
Incidence and Severity of TEAEs
Adverse Events of Special Interest (AESI)
Incidence of AESIs related to the surgical procedure and local reaction to the implant over time
Deaths
Incidence of study deaths
Serious Adverse Events (SAEs)
Incidence of SAEs
AUC0-t of naltrexone
area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
AUC0-t of 6-beta-naltrexol
area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
AUC0-infinity of naltrexone
area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
AUC0-infinity of 6-beta-naltrexol
area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
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Go Medical Industries Pty Ltd
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
New York State Psychiatric Institute
Collaborator
Columbia University
Collaborator
The Emmes Company, LLC
Collaborator
University at Buffalo
Collaborator
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