A Phase 1 interventional study of naltrexone implant in Opioid Use Disorder, sponsored by Go Medical Industries Pty Ltd. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Go Medical Industries Pty Ltd · Phase 1, Interventional, and Basic science
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Among 52 studies testing naltrexone in Opioid-Related Disorders — 1 open to participants now, 2 under way, none of them phase 3. Naltrexone · Opioid-Related Disorders.
Among the 52 studies testing naltrexone in Opioid-Related Disorders, this one is the 39th largest by enrollment, is the only one that started in 2019, is one of 7 in phase 1, and was the 45th registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →1 of the 52 studies testing naltrexone in Opioid-Related Disorders is open now. Recruiting first, the newest first:
Go Medical Industries Pty Ltd
Ages 18–65
Naltrexone: first FDA approval 1984 (REVIA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 53 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 22 · Phase 3 18 · Phase 4 10
First in 1993; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 63 across 1,167 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 61 across the 52 interventional studies. Of the 46 that completed or were terminated, 27 (59%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 52 have an industry lead sponsor. The 10 most frequent:
Go Medical Industries Pty Ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Go Medical Industries Pty Ltd has 3 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
1 of the studies testing naltrexone in Opioid-Related Disorders that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04464980NYU Langone HealthOptimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) | 2026-12-31 |
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Among the 52 studies testing naltrexone in Opioid-Related Disorders, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.
Naltrexone (NTX) is a nonspecific pure opioid antagonist with a high affinity for the µ-opioid receptor. It blocks the effects of opioids by competitive binding at opiate receptors. NTX is used primarily in the management of opiate and alcohol dependence. It is available in the United States (US) as 2 formulations; a once daily oral formulation (Revia) and a once monthly intramuscular injection (Vivitrol). While NTX is a potent antagonist and efficiently blocks the effects of exogenous opiates such as heroin, the success of NTX for the treatment of opiate dependence has been limited by poor patient compliance. Therefore, the development of a sustained release NTX formulation (in excess of 1 month) would be of great benefit for the treatment of opioid use disorder.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
Drug: naltrexone implant
1.8 g implant containing 60% naltrexone
Also known as: OLANI, O'Neil Long Acting Naltrexone Implant
Percentage of Participants That Maintain MEC
Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days
Time frame: up to 540 days or until NTX blood levels become undetectable
Median Cmax of Naltrexone
Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1
Time frame: pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days
Tmax of Naltrexone
Single-dose PK measurement of the time to reach the maximum (Tmax) naltrexone concentration after dosing on Day 1
Time frame: pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days
AUC of Naltrexone
Single-dose PK measurement of the area under the curve (AUC) for naltrexone after dosing on Day 1
Time frame: pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days
Median Cmax of 6β-naltrexol
Single-dose PK measurement of the peak plasma 6β-naltrexol concentration after dosing on Day 1
Time frame: pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days
Median Tmax of 6β-naltrexol
Single-dose PK measurement of the time to reach the maximum 6β-naltrexol concentration after dosing on Day 1
Time frame: pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days
Time>Minimum Effective Concentration
Time (T) naltrexone remains above the minimum effective concentration (MEC) of 1.33
Time frame: pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days
AUC of 6β-naltrexol
Single-dose PK measurement of the AUC for 6β-naltrexol concentration after dosing on Day 1
Time frame: pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days
Incidence of Adverse Events (AEs)
Incidence and Severity of AEs
Time frame: Up to 540 days or until NTX blood levels become undetectable
| Milestone | OLANI (Naltrexone Implant) |
|---|---|
| Started | 20 |
| Completed | 17 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 1 |
Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days
| Participants | OLANI (Naltrexone Implant) |
|---|---|
| Percentage of Participants That Maintain MEC | 10 |
Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1
| ng/mL | OLANI (Naltrexone Implant) |
|---|---|
| Median Cmax of Naltrexone | 17.00 (5.38 to 71.4) |
Single-dose PK measurement of the time to reach the maximum (Tmax) naltrexone concentration after dosing on Day 1
| day | OLANI (Naltrexone Implant) |
|---|---|
| Tmax of Naltrexone | 49.63 (0.47 to 268) |
Single-dose PK measurement of the area under the curve (AUC) for naltrexone after dosing on Day 1
| day*ng/mL | OLANI (Naltrexone Implant) |
|---|---|
| AUC of Naltrexone | 1440.5 (991.1 to 2022) |
Single-dose PK measurement of the peak plasma 6β-naltrexol concentration after dosing on Day 1
| ng/mL | OLANI (Naltrexone Implant) |
|---|---|
| Median Cmax of 6β-naltrexol | 23.45 (10.2 to 126) |
Single-dose PK measurement of the time to reach the maximum 6β-naltrexol concentration after dosing on Day 1
| day | OLANI (Naltrexone Implant) |
|---|---|
| Median Tmax of 6β-naltrexol | 49.70 (1 to 176.3) |
Time (T) naltrexone remains above the minimum effective concentration (MEC) of 1.33
| days | OLANI (Naltrexone Implant) |
|---|---|
| Time>Minimum Effective Concentration | 270 (56 to 360) |
Single-dose PK measurement of the AUC for 6β-naltrexol concentration after dosing on Day 1
| day*ng/mL | OLANI (Naltrexone Implant) |
|---|---|
| AUC of 6β-naltrexol | 2856.50 (1484 to 4990) |
Incidence and Severity of AEs
| participants | OLANI (Naltrexone Implant) |
|---|---|
| Participants with at least One Treatment-Emergent Adverse Event | 19 |
| Implant site inflammation | 7 |
| Vomiting | 7 |
| Headache | 5 |
| Implant site pruritus | 4 |
| Nausea | 3 |
| Diarrhoea | 3 |
| Upper respiratory tract infection | 3 |
| Implant site pain | 2 |
| Back pain | 2 |
| Weight increased | 2 |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OLANI (Naltrexone Implant) | 0/20 (0%) | 2/20 (10%) | 19/20 (95%) |
| Event | OLANI (Naltrexone Implant) |
|---|---|
| Stab WoundInjury, poisoning and procedural complications | 1/20 |
| VomitingGastrointestinal disorders | 1/20 |
| Event | OLANI (Naltrexone Implant) |
|---|---|
| VomitingGastrointestinal disorders | 7/20 |
| Implant site inflammationGeneral disorders | 7/20 |
| HeadacheNervous system disorders | 5/20 |
| Implant site pruritusGeneral disorders | 4/20 |
| DiarrhoeaGastrointestinal disorders | 3/20 |
| NauseaGastrointestinal disorders | 3/20 |
| Upper respiratory tract infectionInfections and infestations | 3/20 |
| Implant site painGeneral disorders | 2/20 |
| Weight increasedInvestigations | 2/20 |
| Back painMusculoskeletal and connective tissue disorders | 2/20 |
| Age, Continuous(years) | OLANI (Naltrexone Implant) |
|---|---|
| Mean | 38.4 ± 10.77 |
| Sex: Female, Male(Participants) | OLANI (Naltrexone Implant) |
|---|---|
| Female | 10 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | OLANI (Naltrexone Implant) |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | OLANI (Naltrexone Implant) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 5 |
| More than one race | 3 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | OLANI (Naltrexone Implant) |
|---|---|
| United States | 20 |
| Body Mass Index (kg/m^2)(kg/m^2) | OLANI (Naltrexone Implant) |
|---|---|
| Mean | 24.92 ± 3.63 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2019 to primary completion in Mar 2021, 23 months.
Results were first posted in Aug 2022, 1 year 4 months after primary completion.
Of 78 phase 1 interventional studies under Opioid-Related Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's 23 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naltrexone
Go Medical Industries Pty Ltd