Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Familial Alcoholism Vulnerability

In brief

The purpose of this study is to evaluate the role of Mavoglurant in clarifying the neurobiology of alcoholism risk. This is a one-site, randomized, within subjects, counterbalanced double-blind study of a single dose (200mg) of Mavoglurant and placebo.

Key facts

Study ID: NCT05203965
Run by: Yale University
People needed: 80
Starts: 2022-05-17
Expected to finish: 2026-07-31
Last updated by the study team: 2025-10-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Ages 18-45 years
Estimated full-scale IQ>70
Individual can cooperate with all study procedures
No history of neurological disorder (e.g., epilepsy)
No major medical condition (e.g., cancer)
No history of significant head trauma
Stable medication treatment 6 weeks prior to study enrollment
Negative urine drug and breathe alcohol test at time of MRI scan
Negative urine pregnancy test at time of MRI scan
No MR contra-indications (e.g., in-body metal implant, severe claustrophobia)
No contra-indications to study drug

You may not qualify if…

A diagnosis of any psychotic disorder, or current mood or anxiety disorders under DSM-V, using the SCID-V-RV psychiatric interview
A current diagnosis of: a) Alcohol use disorder, if severe (AUD, mild or moderate OK if no craving, tolerance, and withdrawal 3 months prior to interview) b) Substance use disorder
Report of psychotic disorder in a 1º relative
Auditory or visual impairment that interferes with test-taking
Prenatal exposure to alcohol plus currently meeting criteria for features of fetal alcohol syndrome
Not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English > grade 1
Intellectual Disability (Full Scale IQ<70)
Traumatic brain injury with loss of consciousness > 30 minutes or concussion in last 30 days
Presence or history of neurosurgery or any neurologic illness that may affect brain physiology (e.g., epilepsy, Multiple Sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a board certified radiologist)
A current major medical condition (e.g. cancer, heart failure)
Current pregnancy (all females will be tested with urine screens on the day of MRI)
Women not on an effective form of birth control/contraception or abstinent during time of study visits to prevent exposure of the investigational drug to suspected fetus
Current substance use with the exception of marijuana (THC), provided last use of THC was 24+ hours before visit (All participants will receive a urine screen for the presence of marijuana, cocaine, opiates and a breath screen to detect the presence of alcohol)
Inability to comprehend the consent form appropriately
Inability to cooperate with study procedures
Other specific fMRI exclusions include metal devices, clips or fragments in body (orbital xray performed if needed)

Where it is running

Hartford Hospital — Hartford, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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