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Glutamate Modulator

Glutamatergic Modulation + Behavioral Therapy for Alcoholism

Phase 2
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
Active alcohol use disorder, with at least 4 heavy drinking day over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females). In the case of the use of other drugs, alcohol is designated as the primary drug
Capacity to consent and comply with study procedures, including sufficient proficiency in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test whether a glutamate modulator can help people with AUD who are not depressed, and whether it is more effective when combined with behavioral treatment.

Who is the study for?
This trial is for non-depressed adults aged 21-70 with alcohol use disorder, who have had several heavy drinking days recently and want to cut down or stop. They must be physically healthy, not dependent on other substances (except caffeine, nicotine, cannabis), and able to abstain from alcohol safely for at least 24 hours.Check my eligibility
What is being tested?
The study tests if a glutamate modulator can reduce heavy drinking in people with AUD compared to an active control. It also examines whether combining this drug with behavioral treatments improves outcomes using a randomized design where participants receive different combinations of drug and therapy.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to the central nervous system due to the nature of glutamatergic modulation. Participants will be monitored for any adverse reactions throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been drinking heavily almost every day in the past week.
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I can understand and follow the study's procedures and speak English well.
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I am between 21 and 70 years old.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Daily occurrence of Heavy Drinking Days (HDD)
Secondary outcome measures
Daily occurrence of drinking days

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: CI-581a + Medication ManagementExperimental Treatment1 Intervention
Administration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment ( no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits)
Group II: CI-581a + MET/MBRPExperimental Treatment3 Interventions
Administration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided)
Group III: CI-581b + Medication ManagementActive Control1 Intervention
Administration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits)
Group IV: CI-581b + MET/MBRPActive Control3 Interventions
Administration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MET
2017
Completed Phase 4
~770
CI-581a
2013
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,535 Total Patients Enrolled
17 Trials studying Alcoholism
1,298 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
812 Previous Clinical Trials
1,158,317 Total Patients Enrolled
428 Trials studying Alcoholism
778,237 Patients Enrolled for Alcoholism
Elias Dakwar, MDPrincipal Investigator - NYSPI/Columbia
New York State Psychiatric Institute
Creighton University School Of Medicine (Medical School)
9 Previous Clinical Trials
417 Total Patients Enrolled
1 Trials studying Alcoholism
50 Patients Enrolled for Alcoholism
~4 spots leftby Aug 2024
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