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Glutamate Modulator
CI-581-a for Opioid Addiction
Phase 3
Waitlist Available
Led By Elias Dakwar, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 to 70 years
In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12
Awards & highlights
Study Summary
This trial is testing if a glutamate modulator can help with a rapid non-opioid based naltrexone induction, to help prevent opioid use disorders.
Who is the study for?
This trial is for adults aged 18-70 with opioid use disorder for at least six months, confirmed by tests. Participants must be in good health as determined by medical exams and lab tests, not on conflicting medications, and interested in naltrexone treatment. Pregnant or breastfeeding women, those with certain psychiatric disorders or unstable physical conditions like severe hypertension or liver disease are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of two glutamate modulators (CI-581-a and CI-581-b) to quickly start patients on extended-release naltrexone without using opioids. It's a randomized controlled trial where participants receive one of the test drugs to see if it helps prevent relapse after detoxification from opioids.See study design
What are the potential side effects?
Potential side effects may include reactions related to the central nervous system due to glutamate modulation such as headaches, dizziness, or mood changes; gastrointestinal issues; possible liver enzyme elevations; and any known risks associated with naltrexone including nausea and risk of overdose if opioids are used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
My overall health is good, as confirmed by recent medical exams and tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic imaging procedure
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CI-581aExperimental Treatment1 Intervention
CI-581a will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated.
(0.11 mg/kg 2-min bolus followed by 1.3 mg/kg over 90 min)
Group II: CI-581bPlacebo Group1 Intervention
CI-581b will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated.
(2-min saline bolus followed by 0.0125 mg/kg over 90 min)
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,488 Previous Clinical Trials
2,622,551 Total Patients Enrolled
5 Trials studying Opioid Addiction
648 Patients Enrolled for Opioid Addiction
New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,555 Total Patients Enrolled
Elias Dakwar, MDPrincipal Investigator - NYSPI
New York State Psychiatric Institute
Creighton University School Of Medicine (Medical School)
9 Previous Clinical Trials
437 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medications that could react badly with the study drugs.I am interested in taking extended-release naltrexone for maintenance.I do not have uncontrolled high blood pressure, severe anemia, active liver disease, or untreated diabetes.I am between 18 and 70 years old.My overall health is good, as confirmed by recent medical exams and tests.I have chronic pain that might need opioids or surgery.I have had reactions to similar medications in past studies.I am not pregnant, breastfeeding, and I am willing to use birth control.I am on a buprenorphine treatment or use it regularly.I use methadone regularly or am on a methadone maintenance program.
Research Study Groups:
This trial has the following groups:- Group 1: CI-581a
- Group 2: CI-581b
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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