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

Conditions

• Familial Alcoholism Vulnerability

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Mavoglurant (AFQ056) — DRUG
  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 — DRUG
  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.

Study Details

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 Dates

Start date

May 17, 2022

Status verified

Oct 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

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.

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 ]

Central Contacts

• Godfrey D Pearlson, MD
  203-737-3416
  [email protected]

Locations (1)

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