Trial · NCT05382091
Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
NCT05382091, Phase 2, Not yet recruiting, Go Medical Industries Pty Ltd
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons. Trials, record NCT05382091. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05382091
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
- NCT number
- NCT05382091
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 250 participants, estimated
- Lead sponsor
- Go Medical Industries Pty Ltd
- Conditions
- Opioid Use Disorder
- Interventions
- naltrexone implant
- First posted
- 2022-05-19
- Last updated
- 2026-09-28
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Emergent Adverse Events (TEAEs) | time from from placement of first implant set until end of study at 60 weeks. | Incidence and Severity of TEAEs |
| Primary | Adverse Events of Special Interest (AESI) | 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 |
| Primary | Deaths | time from from placement of first implant set until end of study at 60 weeks. | Incidence of study deaths |
| Primary | Serious Adverse Events (SAEs) | time from from placement of first implant set until end of study at 60 weeks. | Incidence of SAEs |
| Primary | Adverse events (AEs) causing study discontinuation | time from from placement of first implant set until end of study at 60 weeks. | AEs that lead to study discontinuation |
| Primary | Opioid overdose events | time from from placement of first implant set until end of study at 60 weeks. | Incidence of opioid overdose events |
| Primary | Laboratory abnormalities | time from from placement of first implant set until end of study at 60 weeks. | Incidence and Severity of lab abnormalities |
| Primary | Suicidality | 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) |
| Primary | Concomitant medications | time from from placement of first implant set until end of study at 60 weeks. | Proportion of participants who initiate concomitant medications |
| Secondary | AUC0-t of naltrexone | 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. | area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t) |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UH3DA047720 | Evaluation of safety and pharmacokinetics of naltrexone implant | BISAGA, ADAM; NUNES, EDWARD V. | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE ON DRUG ABUSE | 2021 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05382091
GET https://conductscience.org/api/trials/v1/NCT05382091/registered?page=2