At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 9 enrolled
Drug / intervention
Naltrexone 380 MGdrug
Likely dose
Naltrexone 380 mg intramuscularly every 28 days (Vivitrol)AI-extracted
Key inclusion· 6
- ✓Completed prior GM0017 study (received OLANI 3.6g implant and demonstrated naltrexone levels <0.1 ng/mL on two consecutive monthly samples)
- ✓Age 18 to <58 years old
- ✓No active substance use disorder (DSM-5); sustained remission is acceptable
- ✓Weight 45.3–81.6 kg OR BMI 18.5–30.0
Key exclusion· 11
- ✕Currently on active naltrexone medication
- ✕Positive urine drug screen at screening for illicit substances
- ✕Requires opioid-based medication for any condition
- ✕Known hypersensitivity or allergy to naltrexone or Vivitrol components (carboxymethylcellulose sodium, polysorbate 20, sodium chloride, sodium hydroxide, hydrochloric acid, water for injection)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Bioequivalence Study Comparing Vivitrol and O'Neil Long Acting Naltrexone Implant (OLANI) in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating Naltrexone 380 MG for Opioid-use Disorder. Completed, enrolled 9 participants across 1 site.
Detailed Summary
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-use Disorder
CountriesUnited States
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartJan 2021
Primary CompletionApr 2022
TodayJul 2026
First PostedJan 20, 2021
Enrollment StartJan 25, 2021
Primary CompletionApr 4, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.5 years ago
Interventions
Naltrexone 380 MGdrug
Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days