A Phase 1 interventional study of Naltrexone 380 MG 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 57 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-23.
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 48th largest by enrollment, is one of 3 that started in 2021, is one of 7 in phase 1, and was the 50th 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 57 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. 3 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 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 |
Add it to your calendar (.ics) → With an account.
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 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.
This is a Phase I, single-center, single arm, open-label study, to establish the PK parameters of Vivitrol 380 mg IM injection (IP), a US FDA approved medication. Participants will be healthy volunteers with no significant medical or mental health disorders, who have completed participation in clinical trial GM0017 (i.e. have received the OLANI treatment and have subsequently provided two consecutive plasma levels of naltrexone (NTX) \<0.1ng/mL).
This study will examine the PK profile of Vivitrol IM 380 mg over 6 doses for a treatment period of 196 days. Intense sampling will occur after the 1st and 6th dose of Vivitrol. Participants will be without a DSM 5 - Substance Related Disorders classification. Participants will be required to undergo a Naloxone Challenge Test (NCT) to confirm opiate naivety before administration of the IP. No randomization will occur.
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.
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.
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.
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Drug: Naltrexone 380 MG
Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
Also known as: Vivitrol
Median Cmax of Naltrexone (After 1st Dose)
Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Tmax of Naltrexone (After 1st Dose)
Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median AUC0-inf of Naltrexone (After 1st Dose)
Single-dose PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Ctrough of Naltrexone (After 1st Dose)
Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Cmax of 6β-naltrexol (After First Dose)
Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Tmax of 6β-naltrexol (After 1st Dose)
Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median AUC0-inf of 6β-naltrexol (After 1st Dose)
Single-dose PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Ctrough of 6β-naltrexol (After 1st Dose)
Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Cmax of Naltrexone (After 6th Dose)
PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Tmax of Naltrexone (After 6th Dose)
PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median AUC0-inf of Naltrexone (After 6th Dose)
PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Ctrough of Naltrexone (After 6th Dose)
PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Cmax of 6β-naltrexol (After 6th Dose)
PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Tmax of 6β-naltrexol (After th Dose)
PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median AUC0-inf of 6β-naltrexol (After 6th Dose)
PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Ctrough of 6β-naltrexol (After 6th Dose)
PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Adverse Events (AEs)
Proportion of participants reporting AEs
Time frame: Up to Day 196
Naltrexone Accumulation Ratio (AR) for Cmax
The naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Time frame: 196 days after the 6th dose
Naltrexone Accumulation Ratio (AR) for Ctrough
The naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Time frame: 196 days after the 6th dose
Naltrexone Accumulation Ratio (AR) for AUC0-inf
The naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Time frame: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for Cmax
The 6β-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Time frame: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for Ctrough
The 6β-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Time frame: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for AUC0-inf
The 6β-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Time frame: 196 days after the 6th dose
| Milestone | Vivitrol (Naltrexone) |
|---|---|
| Started | 9 |
| Completed | 7 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 1 |
Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Cmax of Naltrexone (After 1st Dose) | 14.10 (13.40 to 23.10) |
Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0
| day | Vivitrol (Naltrexone) |
|---|---|
| Median Tmax of Naltrexone (After 1st Dose) | 2.00 (1.96 to 3.02) |
Single-dose PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
| day*ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median AUC0-inf of Naltrexone (After 1st Dose) | 153.00 (107.01 to 180.83) |
Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Ctrough of Naltrexone (After 1st Dose) | 0.81 (0.49 to 1.06) |
Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Cmax of 6β-naltrexol (After First Dose) | 20.50 (17.30 to 26.10) |
Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0
| day | Vivitrol (Naltrexone) |
|---|---|
| Median Tmax of 6β-naltrexol (After 1st Dose) | 3.02 (2.00 to 3.15) |
Single-dose PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
| day*ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median AUC0-inf of 6β-naltrexol (After 1st Dose) | 270.16 (216.32 to 342.38) |
Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Ctrough of 6β-naltrexol (After 1st Dose) | 1.71 (1.33 to 1.97) |
PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Cmax of Naltrexone (After 6th Dose) | 14.00 (11.80 to 17.60) |
PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140
| day | Vivitrol (Naltrexone) |
|---|---|
| Median Tmax of Naltrexone (After 6th Dose) | 2.00 (1.97 to 2.94) |
PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
| day*ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median AUC0-inf of Naltrexone (After 6th Dose) | 167.14 (127.03 to 199.65) |
PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Ctrough of Naltrexone (After 6th Dose) | 1.37 (0.52 to 1.75) |
PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Cmax of 6β-naltrexol (After 6th Dose) | 24.70 (19.50 to 31.00) |
PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140
| day | Vivitrol (Naltrexone) |
|---|---|
| Median Tmax of 6β-naltrexol (After th Dose) | 2.95 (2.00 to 3.02) |
PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
| day*ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median AUC0-inf of 6β-naltrexol (After 6th Dose) | 310.49 (217.12 to 367.51) |
PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
| ng/mL | Vivitrol (Naltrexone) |
|---|---|
| Median Ctrough of 6β-naltrexol (After 6th Dose) | 2.02 (1.45 to 3.50) |
Proportion of participants reporting AEs
| Participants | Vivitrol (Naltrexone) |
|---|---|
| Adverse Events (AEs) | 4 |
The naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
| ratio | Vivitrol (Naltrexone) |
|---|---|
| Naltrexone Accumulation Ratio (AR) for Cmax | 0.96 ± 49.16 |
The naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
| ratio | Vivitrol (Naltrexone) |
|---|---|
| Naltrexone Accumulation Ratio (AR) for Ctrough | 1.58 ± 33.91 |
The naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
| ratio | Vivitrol (Naltrexone) |
|---|---|
| Naltrexone Accumulation Ratio (AR) for AUC0-inf | 1.08 ± 12.27 |
The 6β-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
| ratio | Vivitrol (Naltrexone) |
|---|---|
| 6β-naltrexol Accumulation Ratio (AR) for Cmax | 1.08 ± 0.63 |
The 6β-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
| ratio | Vivitrol (Naltrexone) |
|---|---|
| 6β-naltrexol Accumulation Ratio (AR) for Ctrough | 1.37 ± 34.53 |
The 6β-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
| ratio | Vivitrol (Naltrexone) |
|---|---|
| 6β-naltrexol Accumulation Ratio (AR) for AUC0-inf | 1.14 ± 7.43 |
Collected over 196 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vivitrol (Naltrexone) | 0/8 (0%) | 0/8 (0%) | 4/8 (50%) |
| Event | Vivitrol (Naltrexone) |
|---|---|
| Injection site inflammationGeneral disorders | 1/8 |
| Injection site painGeneral disorders | 1/8 |
| Corona virus infectionInfections and infestations | 1/8 |
| Foot fractureInjury, poisoning and procedural complications | 1/8 |
| Humerus fractureInjury, poisoning and procedural complications | 1/8 |
| UrticariaSkin and subcutaneous tissue disorders | 1/8 |
| Aborted pregnancySocial circumstances | 1/8 |
| Age, Continuous(years) | Vivitrol (Naltrexone) |
|---|---|
| Median | 50.0 (40 to 55) |
| Sex: Female, Male(Participants) | Vivitrol (Naltrexone) |
|---|---|
| Female | 5 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Vivitrol (Naltrexone) |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Vivitrol (Naltrexone) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Vivitrol (Naltrexone) |
|---|---|
| United States | 9 |
| Body Mass Index (kg/m^2)(kg/m^2) | Vivitrol (Naltrexone) |
|---|---|
| Median | 25.90 (22.8 to 29.9) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Apr 2022, 14 months.
Results were first posted in Jun 2023, 1 year 2 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 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Naltrexone
Go Medical Industries Pty Ltd