Familial Alcoholism VulnerabilityEarly Phase 1NCT03341715
Metabotropic Glutamate Receptor-5 (mGlur5) Effects on Reward-Related fMRI-BOLD Activation in FHP and FHN
A Early Phase 1 study testing Mavoglurant (AFQ056) in people with Familial Alcoholism Vulnerability, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Alcoholism Vulnerability
- What is being tested?
- Mavoglurant (AFQ056)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 13 Nov 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Familial Alcoholism Vulnerability
- Being tested
- Mavoglurant (AFQ056), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Monetary Incentive Delay (MID) task
BOLD activation during A1 phase of MID
Measured: 2 Hours post medication administration
Secondary outcomes (1)
MRI Alcohol Cue Reactivity (ACR) task
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.
Measured: 2 Hours post medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Jun 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Alcoholism VulnerabilityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341715
- Sponsor's protocol ID
- HHC-2017-0172
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 2017
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabotropic Glutamate Receptor-5 (mGlur5) Effects on Reward-Related fMRI-BOLD Activation in FHP and FHN
- ClinicalTrials.gov ID
- NCT03341715
- Acronym / sponsor ID
- HHC-2017-0172
- Conditions
- Familial Alcoholism Vulnerability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mavoglurant (AFQ056) | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Mavoglurant (AFQ056) |
| PlaceboTwo matching tablets of placebo will be administered on the morning of 1 of the 2 experimental days by an RN or the physician investigator. | Other | Placebo |
Primary outcome
MRI Monetary Incentive Delay (MID) task
Time frame: 2 Hours post medication administration
BOLD activation during A1 phase of MID
1 secondary outcome
MRI Alcohol Cue Reactivity (ACR) task
Time frame: 2 Hours post medication administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mavoglurant (AFQ056) in people with Familial Alcoholism Vulnerability, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Monetary Incentive Delay (MID) task (time frame: 2 Hours post medication administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.