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mGluR5 Inhibitor

Mavoglurant for Alcoholism

Q: What criteria must a person meet to be considered an eligible participant in this trial?

This research is searching for 80 volunteers, ranging in age from 18 to 45 years old with alcoholism. Furthermore, participants must have an IQ higher than 70, be medically stable and not pregnant at the time of <a href="https://www.withpower.com/clinical-trials/mri">MRI</a> scan along with other criteria such as no major medical conditions or head trauma history and being able to complete <a href="https://www.withpower.com/clinical-trials/all">all</a> study procedures without difficulty. Additionally they must not have any contra-indications to undergoing Magnetic Resonance Imaging (MRI) scans nor a past neurological disorder like <a href="https://www.withpower.com/clinical-trials/epilepsy">epilepsy</a>.

Q: How many participants have been invited to join this research?

Affirmative. According to information on clinicaltrials.gov, this medical research is actively looking for participants. It was first launched in May 17th 2022 and last revised June 1st 2022 with the aim of enrolling 80 individuals from a single location.

Q: Is enrollment available for the current iteration of this research?

Affirmative. Evidence hosted on clinicaltrials.gov indicates that, as of June 1st 2022, this medical experiment is still searching for qualified participants. 80 patients must be recruited from one location since the trial was initially published on May 17th 2022.

Q: Are geriatric individuals being asked to participate in the experiment?

This medical trial is currently accepting participants who are within the 18-45 age bracket.

Phase < 1

Recruiting

Led By Godfrey D Pearlson, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No major medical condition (e.g., cancer)

Ages 18-45 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mavoglurant and placebo administration are 1 week apart

Awards & highlights

Study Summary

This trial is testing if Mavoglurant could help treat alcoholism by clarifying the neurobiology of alcoholism risk.

Who is the study for?

This trial is for individuals aged 18-45 with an IQ over 70, who can follow study procedures and have no major neurological disorders, medical conditions like cancer, significant head trauma, or metal implants. Participants must test negative for drugs/alcohol and women must not be pregnant nor planning to become so during the trial.Check my eligibility

What is being tested?

The study tests Mavoglurant's effects on alcoholism risk by comparing it against a placebo in a controlled environment. Each participant will receive both treatments at different times (200mg dose) without knowing which one they're getting first.See study design

What are the potential side effects?

While specific side effects are not listed here, participants should be aware that any drug can cause reactions ranging from mild discomfort to more serious complications depending on individual health factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any major medical conditions like cancer.

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I am between 18 and 45 years old.

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I have never had a neurological disorder like epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mavoglurant and placebo administration are 1 week apart

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mavoglurant and placebo administration are 1 week apart

This trial's timeline: 3 weeks for screening, Varies for treatment, and mavoglurant and placebo administration are 1 week apart for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BOLD activation to alcohol vs. non-alcohol stimuli during ACR task alcohol versus non-alcohol stimuli

Change in Nucleus accumbens (Nacc)/Ventral striatum (VS) BOLD activation during A1 phase in FHP on study medication vs. placebo

Secondary outcome measures

Dynamic Causal Modeling (DCM)-determined relationships between nucleus accumbens (NAcc) and -medial PFC BOLD signal during MSDM task

Regional differences in BOLD signal

Trial Design

4Treatment groups

Experimental Treatment

Group I: FHP; Placebo-MavoglurantExperimental Treatment2 Interventions

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.

Group II: FHP; Mavoglurant-PlaceboExperimental Treatment2 Interventions

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.

Group III: FHN; Placebo-MavoglurantExperimental Treatment2 Interventions

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.

Group IV: FHN; Mavoglurant-PlaceboExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mavoglurant (AFQ056)

2018

Completed Early Phase 1

~20

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

801 Previous Clinical Trials

1,365,317 Total Patients Enrolled

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,133 Total Patients Enrolled

Godfrey D Pearlson, MDPrincipal InvestigatorYale University

2 Previous Clinical Trials

120 Total Patients Enrolled

Media Library

Mavoglurant (AFQ056) (mGluR5 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05203965 — Phase < 1

Alcoholism Vulnerability Research Study Groups: FHP; Mavoglurant-Placebo, FHP; Placebo-Mavoglurant, FHN; Mavoglurant-Placebo, FHN; Placebo-Mavoglurant

Alcoholism Vulnerability Clinical Trial 2023: Mavoglurant (AFQ056) Highlights & Side Effects. Trial Name: NCT05203965 — Phase < 1

Mavoglurant (AFQ056) (mGluR5 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05203965 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a person meet to be considered an eligible participant in this trial?

"This research is searching for 80 volunteers, ranging in age from 18 to 45 years old with alcoholism. Furthermore, participants must have an IQ higher than 70, be medically stable and not pregnant at the time of MRI scan along with other criteria such as no major medical conditions or head trauma history and being able to complete all study procedures without difficulty. Additionally they must not have any contra-indications to undergoing Magnetic Resonance Imaging (MRI) scans nor a past neurological disorder like epilepsy."

Answered by AI

How many participants have been invited to join this research?

"Affirmative. According to information on clinicaltrials.gov, this medical research is actively looking for participants. It was first launched in May 17th 2022 and last revised June 1st 2022 with the aim of enrolling 80 individuals from a single location."

Answered by AI

Is enrollment available for the current iteration of this research?

"Affirmative. Evidence hosted on clinicaltrials.gov indicates that, as of June 1st 2022, this medical experiment is still searching for qualified participants. 80 patients must be recruited from one location since the trial was initially published on May 17th 2022."

Answered by AI