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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 belowTimeline
Screening ~ 3 weeks3 visits
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
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
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 moreSecondary 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 moreSide effects data
From 2022 Phase 1 trial • 9 Patients • NCT0471688113%
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
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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.
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