Trial · NCT05382091
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| 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) |
| Secondary | AUC0-t of 6-beta-naltrexol | 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) |
| Secondary | AUC0-infinity 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 extrapolated to infinity (AUC0-infinity) |
| Secondary | AUC0-infinity of 6-beta-naltrexol | 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 extrapolated to infinity (AUC0-infinity) |
| Secondary | Cmax 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. | Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1 |
| Secondary | Cmax of 6-beta-naltrexol | 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. | Single-dose PK measurement of the plasma 6-beta-naltrexol concentration (Cmax) after dosing on Day 1 |
| Secondary | Tmax 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. | Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1 |
| Secondary | Tmax of 6-beta-naltrexol | 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. | Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1 |
| Secondary | Proportion of participants that maintain a minimum plasma concentration | up to Week 60 | Proportion of participants who maintain NTX blood levels of ≥2 ng/mL |
| Secondary | Proportion of participants that maintain a minimum plasma concentration | up to Week 60 | Proportion of participants who maintain NTX blood levels of ≥1.16 ng/mL |
| Secondary | Abstinence from drugs of abuse by UDS | pre-dose (prior to each implant procedure) and at every study visit through Week 60. | 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) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05382091/registered