Mavoglurant in Alcohol Drinking

NCT03327792 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 20000217032P50AA012870-21
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this alcohol-interaction pilot study is to provide information on the effect of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related responses. This is a between subjects double blind randomized design in which the investigators plan to run 40 subjects to obtain 28 completers.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• Abnormal Labs and Adverse Events

  Number of participants (at Day 10; after both alcohol sessions and completed course of mavoglurant) with abnormal lab values or adverse events related to the interaction of alcohol and mavoglurant

  Day 10

Study Arms (2)

200 mg Mavoglurant

EXPERIMENTAL

200 mg mavoglurant once daily for 7-10 days

Drug: Mavoglurant

Placebo

PLACEBO COMPARATOR

Placebo once daily for 7-10 days

Drug: Placebo

Interventions

Mavoglurant DRUG

200 mg Mavoglurant

200 mg Mavoglurant

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 21-50
• Able to read English at 6th grade level or higher and to complete study evaluations
• Social drinkers
• Willing to abstain from drinking alcohol during the outpatient study medication treatment period

You may not qualify if:

• Seeking treatment for alcohol drinking
• Current DSM-V criteria for any other substances, other than alcohol or nicotine.
• Positive test results at any appointments after the initial intake appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines and/or barbiturates.
• Regular use of psychoactive drugs including anxiolytics and antidepressants.
• Psychotic or otherwise severely psychiatrically disabled.
• Any medical conditions (including hepatic and renal impairment) that would contraindicate the consumption of alcohol or administration of mavoglurant.
• History of neurological trauma or disease, delirium, or hallucinations, or any significant systemic illness or unstable medical condition.
• Women who are pregnant, nursing, or refuse to use a reliable method of birth control. Urine pregnancy tests will be completed at intake and prior to administration of alcohol at each lab session.
• Subjects who report disliking spirits will be excluded because hard liquor will be provided during the alcohol administration.
• Subjects who have taken any investigational drug and/or participated in another study which involves additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol within 4 weeks immediately preceding admission to the treatment period.
• Subjects who report any daily drug use during the 30 days prior to randomization for the following: anxiolytics, beta blockers, central nervous system stimulants, hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with psychotropic activity or drugs which cause excessive sedation.
• Subjects who have donated blood within the past six weeks.
• Current use (within 30 days of screening) of specific psychoactive medications (e.g., typical neuroleptics, narcotic analgesics, antiparkinsonian medications, systemic corticosteroids, or medications with significant central anticholinergic activity, etc
• Current use of warfarin.
• Use of any medications that are contraindicated with mavoglurant and alcohol.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Dr. Suchitra Krishnan-Sarin
• Organization: Yale University

suchitra.krishnan-sarin@yale.edu

203-974-7595

Study Officials

• Suchitra Krishnan-Sarin, PhD

  Professor of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 31, 2017
• Study Start: February 7, 2018
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Locations

US (1)