NCT05203965 Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant
| NCT ID | NCT05203965 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yale University |
| Condition | Familial Alcoholism Vulnerability |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-05-17 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2022-05-17 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Godfrey D Pearlson, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05203965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Familial Alcoholism Vulnerability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05203965 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05203965 currently recruiting?
Yes, NCT05203965 is actively recruiting participants. Contact the research team at godfrey.pearlson@hhchealth.org for enrollment information.
Where is the NCT05203965 trial being conducted?
This trial is being conducted at Hartford, United States.
Who is sponsoring the NCT05203965 clinical trial?
NCT05203965 is sponsored by Yale University. The principal investigator is Godfrey D Pearlson, MD at Yale University. The trial plans to enroll 80 participants.