← Back to Search

mGluR5 Inhibitor

Mavoglurant for Alcoholism

Phase < 1

Recruiting

Led By Godfrey D Pearlson, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No major medical condition (e.g., cancer)

Ages 18-45 years

Must not have

A diagnosis of any psychotic disorder, or current mood or anxiety disorders under DSM-V, using the SCID-V-RV psychiatric interview

Traumatic brain injury with loss of consciousness > 30 minutes or concussion in last 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mavoglurant and placebo administration are 1 week apart

Summary

This trial is testing if Mavoglurant could help treat alcoholism by clarifying the neurobiology of alcoholism risk.

Who is the study for?

This trial is for individuals aged 18-45 with an IQ over 70, who can follow study procedures and have no major neurological disorders, medical conditions like cancer, significant head trauma, or metal implants. Participants must test negative for drugs/alcohol and women must not be pregnant nor planning to become so during the trial.

What is being tested?

The study tests Mavoglurant's effects on alcoholism risk by comparing it against a placebo in a controlled environment. Each participant will receive both treatments at different times (200mg dose) without knowing which one they're getting first.

What are the potential side effects?

While specific side effects are not listed here, participants should be aware that any drug can cause reactions ranging from mild discomfort to more serious complications depending on individual health factors.

Eligibility Criteria

Inclusion Criteria

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

Select...

I do not have any major medical conditions like cancer.

Select...

I am between 18 and 45 years old.

Select...

I have never had a neurological disorder like epilepsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been diagnosed with a psychotic, mood, or anxiety disorder.

Select...

I had a head injury with unconsciousness over 30 minutes or a recent concussion.

Select...

I cannot follow the study's required procedures.

Select...

I have a serious health condition like cancer or heart failure.

Select...

A close family member has a psychotic disorder.

Select...

I am not currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mavoglurant and placebo administration are 1 week apart

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mavoglurant and placebo administration are 1 week apart

This trial's timeline: 3 weeks for screening, Varies for treatment, and mavoglurant and placebo administration are 1 week apart for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BOLD activation to alcohol vs. non-alcohol stimuli during ACR task alcohol versus non-alcohol stimuli

Change in Nucleus accumbens (Nacc)/Ventral striatum (VS) BOLD activation during A1 phase in FHP on study medication vs. placebo

Secondary study objectives

Dynamic Causal Modeling (DCM)-determined relationships between nucleus accumbens (NAcc) and -medial PFC BOLD signal during MSDM task

Regional differences in BOLD signal

Trial Design

4Treatment groups

Experimental Treatment

Group I: FHP; Placebo-MavoglurantExperimental Treatment2 Interventions

Family History Positive (FHP) or alcoholism will be given a single dose of placebo then AFQ056 (200 mg) in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures.

Group II: FHP; Mavoglurant-PlaceboExperimental Treatment2 Interventions

Family History Positive (FHP) for alcoholism will be given a single dose of AFQ056 (200 mg) then placebo in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures.

Group III: FHN; Placebo-MavoglurantExperimental Treatment2 Interventions

Family History Negative (FHN) for alcoholism will be given a single dose of placebo then AFQ056 (200 mg) in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures.

Group IV: FHN; Mavoglurant-PlaceboExperimental Treatment2 Interventions

Family History Negative (FHN) for alcoholism will be given a single dose of AFQ056 (200 mg) then placebo in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mavoglurant (AFQ056)

2018

Completed Early Phase 1

~20

Placebo

1995

Completed Phase 3

~2670