Recruiting
Early Phase 1

Mavoglurant

Sponsor:

Yale University

Code:

NCT05203965

Conditions

Familial Alcoholism Vulnerability

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Mavoglurant (AFQ056)

Placebo

Study Details

Brief 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.

Conditions

Familial Alcoholism Vulnerability

Study ID

NCT05203965

Start date

May 17, 2022

Status verified date

Oct, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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 1ยบ 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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: FHP; Mavoglurant-Placebo

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.

experimental: FHP; Placebo-Mavoglurant

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.

experimental: FHN; Mavoglurant-Placebo

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.

experimental: FHN; Placebo-Mavoglurant

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.

Interventions

Mavoglurant (AFQ056)

Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.

Placebo

Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.

Primary outcome measure

  • Change in Nucleus accumbens (Nacc)/Ventral striatum (VS) BOLD activation during A1 phase in FHP on study medication vs. placebo [ Time Frame: Mavoglurant and Placebo administration are 1 week apart ]
  • BOLD activation to alcohol vs. non-alcohol stimuli during ACR task alcohol versus non-alcohol stimuli [ Time Frame: Mavoglurant and Placebo administration are 1 week apart ]

Central Contacts and Locations

Central contacts

Godfrey D Pearlson, MD

203-737-3416godfrey.pearlson@hhchealth.org

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Godfrey D Pearlson, MD

203-737-3416godfrey.pearlson@hhchealth.org

Principal Investigator:

Godfrey D Pearlson, MD

More Information

Sponsor

Yale University

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-10-09.