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Glutamate Modulator

Glutamate Modulators + Behavioral Therapy for Cocaine Use Disorder

Phase 3
Recruiting
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
18-70 years of age
Capacity to consent and comply with study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12
Awards & highlights

Study Summary

This trial will test if drugs that affect glutamate (a substance in the brain) exchange may help people with cocaine use disorders abstain from using cocaine.

Who is the study for?
Adults aged 18-70 with cocaine use disorder, using at least once a week for the past month, and in good physical health can join. They must not have major psychiatric disorders or be dependent on substances needing medical management, nor should they have heart disease or unstable conditions like severe hypertension.Check my eligibility
What is being tested?
The trial is testing glutamate modulators CI-581a and CI-581b alongside behavioral therapies (MET and MBRP) to see if they help people abstain from cocaine. It's randomized and double-blind, meaning neither participants nor researchers know who gets which treatment.See study design
What are the potential side effects?
Potential side effects are not specified but may relate to the modulation of brain chemistry affecting glutamate exchange. Participants will be monitored for any adverse reactions due to these experimental medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I understand and can follow the study's requirements.
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I have not had bad reactions to study medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abstinence from Cocaine Use

Side effects data

From 2017 Phase 2 & 3 trial • 50 Patients • NCT02539511
47%
Sedation
35%
Headache
12%
Mild agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Group: Ketamine+MET
Control Group: Midazolam+MET

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CI-581a+MET+MBRPExperimental Treatment3 Interventions
Administration of CI-581a at 0.71 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
Group II: CI-581b+MET+MBRPActive Control3 Interventions
Administration of CI-581b at 0.025 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CI-581a
2013
Completed Phase 3
~80
Motivational Enhancement Therapy (MET)
2008
Completed Phase 3
~1510
Mindfulness Based Relapse Prevention
2012
Completed Phase 2
~450

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,443 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,757 Total Patients Enrolled
Elias Dakwar, MDPrincipal Investigator - NYSPI
New York State Psychiatric Institute
Creighton University School Of Medicine (Medical School)
9 Previous Clinical Trials
387 Total Patients Enrolled

Media Library

CI-581a (Glutamate Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03344419 — Phase 3
Cocaine Use Disorder Research Study Groups: CI-581a+MET+MBRP, CI-581b+MET+MBRP
Cocaine Use Disorder Clinical Trial 2023: CI-581a Highlights & Side Effects. Trial Name: NCT03344419 — Phase 3
CI-581a (Glutamate Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03344419 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can adults over the age of 25 enroll in this research project?

"The age requirements for participants in this study are that they must have turned 18 years old but not yet reached 70 years old."

Answered by AI

Could you please describe the side effects associated with CI-581a?

"CI-581a's safety is based on multiple rounds of clinical data, coming from Phase 3 trials with some evidence of efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
NYSPI
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Cocaine dependency for years now and have wanted to quit.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
Elias Dakwar 2017. "Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03344419.
~20 spots leftby Apr 2025
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