Exploring the effects of Mavoglurant on alcoholism risk
Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant
This study is testing if a single dose of Mavoglurant can help people at risk for alcoholism due to family history by looking at how it affects their brain activity related to rewards and impulsivity.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT05203965 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a single dose of Mavoglurant, a drug that inhibits metabotropic glutamate receptor-5, on individuals at risk for alcoholism due to familial factors. Conducted as a double-blind, randomized, counterbalanced trial, participants will receive either Mavoglurant or a placebo during two separate visits. The study utilizes functional MRI to assess brain activity related to reward and impulsivity, aiming to clarify the neurobiological mechanisms underlying alcoholism vulnerability. By examining neural circuitry and connectivity across various tasks, the research seeks to enhance understanding of familial alcoholism risk.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 with a familial history of alcoholism and no significant psychiatric or neurological disorders.
Not a fit: Patients with severe alcohol use disorder or significant psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing alcoholism in individuals with a familial predisposition.
How similar studies have performed: While the approach of using Mavoglurant is novel, similar studies exploring the neurobiology of addiction have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hartford, Connecticut
- Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Godfrey D Pearlson, MD — Yale University
- Study coordinator: Godfrey D Pearlson, MD
- Email: godfrey.pearlson@hhchealth.org
- Phone: 203-737-3416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.