NCT05203965 · Yale University
Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant
What this study is about
The purpose of this study is to evaluate the role of Mavoglurant in clarifying the neurobiology of alcoholism risk. This is a one-site, randomly assigned, within subjects, counterbalanced where neither patients nor doctors know which treatment is given study of a single dose (200mg) of Mavoglurant and placebo.
View original scientific description
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.
Interventions
DRUG
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.
DRUG
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 measures
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
Changes in NAcc/VS BOLD (Blood-oxygen-level-dependent) activation during the A1 loss anticipation prospect phase of the MRI Monetary Incentive Delay task in FHP while on mavoglurant compared to placebo
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
Changes in BOLD response in FHP to alcohol versus non-alcohol stimuli in several brain clusters containing MFC, caudate, parahippocampal gyrus, temporal cortex and cerebellum, when administered mavoglurant compared to placebo
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Hartford, Connecticut
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2025 · Source of record for eligibility and locations