A Phase 2 interventional study of naltrexone implant in Opioid Use Disorder, sponsored by Go Medical Industries Pty Ltd. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Go Medical Industries Pty Ltd · Phase 2, Interventional, and Treatment
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.
This is a Phase II, multi-center, open-label study designed to evaluate the safety profile and the efficacy of the OLANI when used in participants who meet the diagnosis of opioid use disorder (OUD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and who will be voluntarily seeking relapse-prevention treatment using the naltrexone (NTX) implant.
Participants eligible for the study have diagnosed OUD, have completed withdrawal from opioids, and are no longer physically dependent at the time of study enrollment. After completing the informed consent process for the study, all participants will receive their initial OLANI set (two implants) implanted subcutaneously by a study surgeon and will be followed by a medical and surgical research team, receiving medical management intervention and blood draws to measure levels of NTX and its metabolite, 6-beta-naltrexol (6BN).
For interested participants, a standard dose of OLANI (standard dose contains 1 x OLANI, for a total of 1.8 g NTX) will be offered 13 weeks (91 days), within an acceptable dosing window of 12-16 weeks (84-112 days) after the initial loading dose, with a preference for participants to receive the dose between 84-91 days. Participants will continue to be offered a repeat standard dose of OLANI every 13 weeks (91 days), within an acceptable dosing window of 12-16 weeks (84-112 days) after their previous dose for a further two repeats. This will result in a maximum of 4 procedures within 36 to 48-weeks. All participants will be followed up until 60 weeks post their initial IP procedure, irrespective of the number of procedures that they have. This will result in a total study duration of 60 weeks for all participants.
Exclusion Criteria:
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:
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
3.6 g per implant set each containing 60% naltrexone
Also known as: OLANI, O'Neil Long Acting Naltrexone Implant
Treatment Emergent Adverse Events (TEAEs)
Incidence and Severity of TEAEs
Time frame: 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 frame: time from from placement of first implant set until end of study at 60 weeks.
Deaths
Incidence of study deaths
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Serious Adverse Events (SAEs)
Incidence of SAEs
Time frame: 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 frame: time from from placement of first implant set until end of study at 60 weeks.
Opioid overdose events
Incidence of opioid overdose events
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Laboratory abnormalities
Incidence and Severity of lab abnormalities
Time frame: 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 frame: 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 frame: time from from placement of first implant set until end of study at 60 weeks.
AUC0-t of naltrexone
area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
Time frame: 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
area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
Time frame: 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
area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
Time frame: 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
area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
Time frame: 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
Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1
Time frame: 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 6-beta-naltrexol
Single-dose PK measurement of the plasma 6-beta-naltrexol concentration (Cmax) after dosing on Day 1
Time frame: 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.
Tmax of naltrexone
Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1
Time frame: 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.
Tmax of 6-beta-naltrexol
Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1
Time frame: 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.
Proportion of participants that maintain a minimum plasma concentration
Proportion of participants who maintain NTX blood levels of ≥2 ng/mL
Time frame: up to Week 60
Proportion of participants that maintain a minimum plasma concentration
Proportion of participants who maintain NTX blood levels of ≥1.16 ng/mL
Time frame: up to Week 60
Abstinence from drugs of abuse by UDS
Proportion of participants who maintain abstinence from opioids, benzodiazepines; barbiturates; cocaine; amphetamine; methamphetamine; phencyclidine (PCP); ecstasy (MDMA); and marijuana (THC) as measured through a urine drug screen (UDS)
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Abstinence from drugs of abuse by Timeline Followback (TLFB)
Proportion of participants who maintain abstinence from opioids, benzodiazepines; barbiturates; cocaine; amphetamine; methamphetamine; phencyclidine (PCP); ecstasy (MDMA); and marijuana (THC) as measured through a urine drug screen (UDS)
Time frame: At every study visit through Week 60 except for days of implant procedures.
Abstinence from alcohol
Proportion of participants who maintain abstinence from alcohol as measured using and alcohol breathalyzer
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Opioid craving (VAS)
The craving for opioids will be measured using a horizontal visual analog scale (VAS), which ranges from 0 (no craving) to 10 (most intense craving possible).
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Opioid withdrawal (SOWS)
The SOWS is a 16-item questionnaire designed to measure the severity of opioid withdrawal symptoms. The participant rates the intensity of symptoms using a 5-point scale; with 0 representing "not at all" and 4 representing "extremely".
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Opioid withdrawal (COWS)
The COWS is a questionnaire designed to measure 11 common opioid withdrawal signs and symptoms. The summed score provides information about the severity of opioid withdrawal and the level of physical dependence on opioids. Total scores range from 0 to 47, and withdrawal is classified as mild (5-12), moderate (13-24), moderately severe (25-36), or severe (\>36)
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Hamilton Depression Rating Scale (HDRS)
Assessment of Depression/Mood via the HDRS, is a clinician-administered instrument, useful for following both depression and suicidal ideation, and for following typical symptoms of subacute withdrawal (e.g., low appetite, fatigue, poor sleep). A score of 1 or more to item 3 (suicidality) prompts a clinician assessment for suicide risk before leaving the clinic.
Time frame: At every study visit through Week 60 except for days of implant procedures.
Brief Symptom Inventory 18 (BSI-18)
Assessment of Depression/Mood via the BSI-18; comprising 18 items (ranging from 0 = not at all to 4 = extremely), assesses psychiatric symptoms in three distinct domains: depression, anxiety, and somatization. The total score ranges from 0 to 72 with higher scores indicating higher symptom severity.
Time frame: Baseline, Day 28, Day 42, Day 56, Day 84, and then every 28 days until Week 60.
Quality of Life Score (QoL)
Quality of life as measured through Quality of Life Enjoyment and Satisfaction Questionnaire (short form). is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). If items are left blank the maximum and minimum scores must be modified to reflect the number of items scored.
Time frame: Day 28, Day 42, Day 56, Day 84, and then every 28 days until Week 60.
Treatment Satisfaction (TSQM-14)
The TSQM-14 is comprised of 14 questions that provide scores on four scales: effectiveness (3 items), side effects (5 items), convenience (3 items) and global satisfaction (3 items). With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100
Time frame: Repeat implant procedure days and at Week 60.
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Go Medical Industries Pty Ltd