Opioid Use DisorderPhase 2GM0020NCT05382091
Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
A Phase 2 study testing naltrexone implant in people with Opioid Use Disorder, run by Go Medical Industries Pty Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- naltrexone implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Have no medical or psychiatric contraindications to treatment either with NTX or with the OLANI, as determined by the site clinician and based on medical history and current health status
- Able to sufficiently speak and understand English and understand study procedures
Show all 11Show fewer
- Able and willing to provide written informed consent
- Able and willing to provide detailed contact information for both self and for close contact(s) on the locator form
- Able and willing to comply with the requirements and procedures of the protocol, including tolerating a minor surgical procedure with local anesthetic for placement of the implant sets into the subcutaneous tissue of the abdomen
- Have an initial weight between 45.3 and 130 kg (inclusive) or have a BMI of 18.5 to 35.0 (inclusive)
- For female participants of childbearing potential, a willingness to practice an effective method of birth control for the duration of participation in the study. Acceptable methods of birth control are specified on the data collection form and in the Manual of Procedures (MOP), and methods other than those specified are not permitted, except in combination with a study-acceptable method; and willingness to complete urine pregnancy testing to confirm non-pregnant status, as per the study schedule and as requested by the site clinician.
Who cannot join
- 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:
- 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
- Has any contraindicated medical condition per the approved labelling for NTX containing products
Show all 17Show fewer
- Has physiological dependence on alcohol and/or sedative-hypnotics that require medical detoxification
- If female, is currently pregnant or breastfeeding, is planning to conceive during the period of study engagement, has a positive blood pregnancy test, or is unwilling to practice effective contraception during study participation
- Has received a NTX implant in the last 12 months
- Has a known hypersensitivity to NTX
- Is not able to provide blood samples due to extensive vein damage
- Has a known hypersensitivity to polylactic acid based materials, including disposable sutures or implants
- Has a known hypersensitivity to local anesthesia
- Is prone to skin rashes, skin irritation, or has a diagnosed or observed skin condition (e.g., recurrent eczema)
- Is tattooed in the proposed implantation area or demonstrates any abnormal skin tissue in the proposed implantation area
- Currently confined or detained in a penal institution or sentenced to such an institution under a criminal or civil statute or detained in other facilities by virtue of statutes.
- Any additional condition(s) that, in the investigator's opinion, would prohibit the participant from completing the study or that would not be in the best interest of the participant.
About this study
Official title: A Phase II Multi-Center Safety Study Examining the Use of the O'Neil Long Acting Naltrexone Implant (OLANI) in Opioid Dependent Persons Receiving Repeat Dosing
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.
Read the detailed description
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.
- Conditions
- Opioid Use Disorder
- Being tested
- naltrexone implant
- Keywords
- naltrexone, opioids, OLANI implant, opioid use disorder, opioid dependence, opioid receptor antagonist
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexone implantDrug
Also called OLANI, O'Neil Long Acting Naltrexone Implant
3.6 g per implant set each containing 60% naltrexone
| Study group | Role | What they receive |
|---|---|---|
| OLANI (naltrexone implant) | Experimental | 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. Receives: Drug: naltrexone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs)
Incidence and Severity of TEAEs
Measured: 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
Measured: time from from placement of first implant set until end of study at 60 weeks.
Deaths
Incidence of study deaths
Measured: time from from placement of first implant set until end of study at 60 weeks.
Serious Adverse Events (SAEs)
Incidence of SAEs
Measured: 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
Measured: time from from placement of first implant set until end of study at 60 weeks.
Opioid overdose events
Incidence of opioid overdose events
Measured: time from from placement of first implant set until end of study at 60 weeks.
Laboratory abnormalities
Incidence and Severity of lab abnormalities
Measured: 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)
Measured: time from from placement of first implant set until end of study at 60 weeks.
Concomitant medications
Proportion of participants who initiate concomitant medications
Measured: time from from placement of first implant set until end of study at 60 weeks.
Secondary outcomes (20)
AUC0-t of naltrexone
area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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".
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Repeat implant procedure days and at Week 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Go Medical Industries Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), New York State Psychiatric Institute, Columbia University, The Emmes Company, LLC, University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Adam Bisaga, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382091
- Sponsor's protocol ID
- GM0020
- Other IDs
- 4UH3DA047720-03, 240359
- Acronym
- GM0020
- Status last verified
- Sep 2026
- First submitted
- 16 May 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Center Safety Study Examining the Use of the O'Neil Long Acting Naltrexone Implant (OLANI) in Opioid Dependent Persons Receiving Repeat Dosing
- ClinicalTrials.gov ID
- NCT05382091
- Acronym / sponsor ID
- GM0020 / GM0020
- Conditions
- Opioid Use Disorder
- Keywords
- naltrexone, opioids, OLANI implant, opioid use disorder, opioid dependence, opioid receptor antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Go Medical Industries Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), New York State Psychiatric Institute, Columbia University, The Emmes Company, LLC, University at Buffalo
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLANI (naltrexone implant) | Experimental | Drug: naltrexone implant2 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Have no medical or psychiatric contraindications to treatment either with NTX or with the OLANI, as determined by the site clinician and based on medical history and current health status
Key exclusion criteria (17 listed)
- 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:
- Has physiological dependence on alcohol and/or sedative-hypnotics that require medical detoxification
- If female, is currently pregnant or breastfeeding, is planning to conceive during the period of study engagement, has a positive blood pregnancy test, or is unwilling to practice effective contraception during study participation
- Has received a NTX implant in the last 12 months
- Has a known hypersensitivity to NTX
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naltrexone implantAlso: OLANI, O'Neil Long Acting Naltrexone Implant3.6 g per implant set each containing 60% naltrexone | Drug | OLANI (naltrexone implant) |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Incidence and Severity of TEAEs
Adverse Events of Special Interest (AESI)
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Incidence of AESIs related to the surgical procedure and local reaction to the implant over time
Deaths
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Incidence of study deaths
Serious Adverse Events (SAEs)
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Incidence of SAEs
Adverse events (AEs) causing study discontinuation
Time frame: time from from placement of first implant set until end of study at 60 weeks.
AEs that lead to study discontinuation
Opioid overdose events
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Incidence of opioid overdose events
Laboratory abnormalities
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Incidence and Severity of lab abnormalities
Suicidality
Time frame: time from from placement of first implant set until end of study at 60 weeks.
incidence of suicidal ideation and suicidal behavior captured with the Columbia-Suicide Severity Rating Scale (C-SSRS)
Concomitant medications
Time frame: time from from placement of first implant set until end of study at 60 weeks.
Proportion of participants who initiate concomitant medications
20 secondary outcomes
AUC0-t of naltrexone
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
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
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
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
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
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
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
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
Time frame: up to Week 60
Proportion of participants that maintain a minimum plasma concentration
Time frame: up to Week 60
Abstinence from drugs of abuse by 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)
Time frame: At every study visit through Week 60 except for days of implant procedures.
Abstinence from alcohol
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Opioid craving (VAS)
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Opioid withdrawal (SOWS)
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Opioid withdrawal (COWS)
Time frame: pre-dose (prior to each implant procedure) and at every study visit through Week 60.
Hamilton Depression Rating Scale (HDRS)
Time frame: At every study visit through Week 60 except for days of implant procedures.
Brief Symptom Inventory 18 (BSI-18)
Time frame: Baseline, Day 28, Day 42, Day 56, Day 84, and then every 28 days until Week 60.
Quality of Life Score (QoL)
Time frame: Day 28, Day 42, Day 56, Day 84, and then every 28 days until Week 60.
Treatment Satisfaction (TSQM-14)
Time frame: Repeat implant procedure days and at Week 60.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Bisaga, MD principal investigator
New York State Psychiatric Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing naltrexone implant in people with Opioid Use Disorder, run by Go Medical Industries Pty Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.