Metabotropic Glutamate Receptor-5 (mGlur5) Effects on Reward-Related fMRI-BOLD Activation in FHP and FHN

NCT03341715 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HHC-2017-0172
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the role of Mavoglurant in clarifying the neurobiology of alcoholism risk. This is a 1-site, randomized, within subjects, counterbalanced double-blind study of a single dose (200mg) of Mavoglurant and placebo.

Conditions

Familial Alcoholism Vulnerability

Outcome Measures

Primary Outcomes (1)

• MRI Monetary Incentive Delay (MID) task

  BOLD activation during A1 phase of MID

  2 Hours post medication administration

Secondary Outcomes (1)

• MRI Alcohol Cue Reactivity (ACR) task

  2 Hours post medication administration

Study Arms (2)

Mavoglurant (AFQ056)

EXPERIMENTAL

The investigators will use a single dose of the AFQ056 (200 mg) versus placebo in random assignment single-blind fashion, administered 2 hours prior to the MRI and other measures, in two separate experimental study visits.

Drug: Mavoglurant (AFQ056)

Placebo

PLACEBO COMPARATOR

The investigators will use a single dose of the AFQ056 (200 mg) versus placebo in random assignment single-blind fashion, administered 2 hours prior to the MRI and other measures, in two separate experimental study visits.

Other: Placebo

Interventions

Mavoglurant (AFQ056) DRUG

2-100mg tablets of Mavoglurant will be administered on the morning of 1 of the 2 experimental days by an RN or the physician investigator.

Mavoglurant (AFQ056)

Placebo OTHER

Two matching tablets of placebo will be administered on the morning of 1 of the 2 experimental days by an RN or the physician investigator.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be able to understand the procedures as judged by their ability to clearly repeat back to the PI or his designee correctly, the purpose and content of the planned research, and willingly agree to participate.

You may not qualify if:

• a diagnosis of DSM-IV psychiatric 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
• mental retardation (Full Scale IQ\<70)
• traumatic brain injury with loss of consciousness \> 30 minutes or concussion in last 30 days
• presence or history of any medical/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 licensed radiologist)
• current pregnancy (all females will be tested with urine screens on the day of MRI);
• 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
• Individuals will be excluded who have taken, within the prior 14 days, the following strong inhibitors or inducers of CYP1A, CYP2C, and CYP3A and CYP3A4: iprofloxacin, enoxacin, fluvoxamine; gemfibrozil; fluconazole, fluvoxamine, ticlopidine; boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; bupropion, fluoxetine, paroxetine, quinidine; avasimibe, carbamazepine, phenytoin, rifampin, and St. John's wort.
• Individuals will also be excluded who have taken, within 14 days, the following moderate inhibitors and inducers of CYP3A: Amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, and verapamil; and bosentan, efavirenz, etravirine, modafinil, and nafcillin.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Interventions

mavoglurant

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: June 1, 2018
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

US (1)