RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-17

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05203965

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Godfrey D Pearlson, MD

CONTACT

203-737-3416

godfrey.pearlson@hhchealth.org

Principal Investigator

Godfrey D Pearlson, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Hartford Hospital

Hartford, Connecticut, 06106

United States

Collaborators and Investigators

Sponsor: Yale University

Godfrey D Pearlson, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-17

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-05-17

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Familial Alcoholism Vulnerability