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Trial record 34 of 123 for:    Recruiting, Not yet recruiting, Available Studies | "Alcoholism"

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

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ClinicalTrials.gov Identifier: NCT03341715
Recruitment Status : Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Familial Alcoholism Vulnerability Drug: Mavoglurant (AFQ056) Other: Placebo Early Phase 1

Detailed Description:

This project explores the effects of 1 dose of AZQ056, an experimental non-competitive antagonist to metabotropic glutamate receptor-5 (mGlur5) developed by Novartis, in a double-blind, randomized, counterbalanced manner on alcoholism risk-relevant tasks.

Drug/placebo will be administered on 2 separate visits separated by 1 week. More specifically, this project examines 4 functional MRI tasks related to different aspects of reward and/or impulsivity-related behavior in different contexts, compares the underlying neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic system to examine N-methyl-D-Aspartate and Dopamine (NMDA/DA) interactions.

The combined measures provide the opportunity to advance our understanding of specific aspects of brain function related to familial alcoholism vulnerability in an already well characterized population as some members evolve into alcohol abuse. In addition, as well as conventional within-task analyses, functional network connectivity and allied approaches will be used to examine brain networks across the above tasks.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metabotropic Glutamate Receptor-5 (mGlur5) Effects on Reward-Related fMRI-BOLD Activation in FHP and FHN
Estimated Study Start Date : January 17, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mavoglurant (AFQ056)
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)
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.

Placebo Comparator: Placebo
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
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.




Primary Outcome Measures :
  1. MRI Monetary Incentive Delay (MID) task [ Time Frame: 2 Hours post medication administration ]
    BOLD activation during A1 phase of MID


Secondary Outcome Measures :
  1. MRI Alcohol Cue Reactivity (ACR) task [ Time Frame: 2 Hours post medication administration ]
    BOLD signal activation in the fusiform area and hippocampus for the alcohol cue reactivity (ACR) task. FHP individuals will show increased BOLD signal activation in the fusiform area and hippocampus to repeated alcohol images.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be first screened toxicologically for drugs of abuse (and for women of childbearing age, pregnancy) by urine testing, any positive test results in exclusion.
  • 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.

Exclusion Criteria:

  1. a diagnosis of DSM-IV psychiatric disorder
  2. report of psychotic disorder in a 1º relative, auditory or visual impairment that interferes with test-taking
  3. prenatal exposure to alcohol plus currently meeting criteria for features of fetal alcohol syndrome
  4. not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English > grade 1
  5. mental retardation (Full Scale IQ<70)
  6. traumatic brain injury with loss of consciousness > 30 minutes or concussion in last 30 days
  7. 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)
  8. current pregnancy (all females will be tested with urine screens on the day of MRI);
  9. All participants will receive a urine screen for the presence of marijuana, cocaine, opiates and a breath screen to detect the presence of alcohol
  10. Inability to comprehend the consent form appropriately
  11. Other specific fMRI exclusions include metal devices, clips or fragments in body (orbital x-ray performed if needed).

    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341715


Contacts
Contact: Godfrey D Pearlson, MD 203-737-3416 Godfrey.Pearlson@hhchealth.org

Locations
United States, Connecticut
Hartford Hospital Not yet recruiting
Hartford, Connecticut, United States, 06102
Contact: Godfrey D Pearlson, MD    203-737-3416    Godfrey.Pearlson@hhchealth.org   
Principal Investigator: Godfrey D Pearlson, MD         
Sponsors and Collaborators
Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03341715     History of Changes
Other Study ID Numbers: HHC-2017-0172
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders