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Opioid Antagonist

Naltrexone 380 MG for Opioid Use Disorder

Phase 1
Waitlist Available
Led By Adam Bisaga, MD
Research Sponsored by Go Medical Industries Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women between ≥18 and <58 years old Without DSM 5 - Substance Related Disorders classification; in sustained remission is not exclusionary
Able and willing to comply with the requirements of the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial will help to establish the pharmacokinetic parameters of Vivitrol 380 mg IM injection.

Eligible Conditions
  • Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median AUC0-inf of 6β-naltrexol (After 1st Dose)
Median AUC0-inf of 6β-naltrexol (After 6th Dose)
Median AUC0-inf of Naltrexone (After 1st Dose)
+13 more
Secondary outcome measures
6β-naltrexol Accumulation Ratio (AR) for AUC0-inf
6β-naltrexol Accumulation Ratio (AR) for Cmax
6β-naltrexol Accumulation Ratio (AR) for Ctrough
+4 more

Side effects data

From 2022 Phase 1 trial • 9 Patients • NCT04716881
13%
Corona virus infection
13%
Foot fracture
13%
Humerus fracture
13%
Injection site inflammation
13%
Injection site pain
13%
Urticaria
13%
Aborted pregnancy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vivitrol (Naltrexone)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vivitrol (naltrexone)Experimental Treatment1 Intervention
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone 380 MG
2021
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Clinilabs, Inc.OTHER
8 Previous Clinical Trials
640 Total Patients Enrolled
Go Medical Industries Pty LtdLead Sponsor
2 Previous Clinical Trials
270 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,594,057 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025