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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)