Mavoglurant in Alcohol Drinking

Phase 1

Completed

• Conditions: Alcohol Drinking
• Interventions: Drug: Placebo; Drug: Mavoglurant

• Registration Number: NCT03327792
• Lead Sponsor: Yale University

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.

Detailed Description

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.

Subjects will participate in two lab sessions, one prior to taking medication and one following 7-10 days of mavoglurant/placebo. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak BAC the investigators have observed in prior research studies. Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-31
• Study Start: 2018-02-07
• Primary Completion: 2023-07-13
• Study Completion: 2023-07-13
• Status Verified: 2024-07
• Results First Submitted: 2024-07-10
• Results First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Results First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Exclusion Criteria

1. Seeking treatment for alcohol drinking
2. Current DSM-V criteria for any other substances, other than alcohol or nicotine.
3. Positive test results at any appointments after the initial intake appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines and/or barbiturates.
4. Regular use of psychoactive drugs including anxiolytics and antidepressants.
5. Psychotic or otherwise severely psychiatrically disabled.
6. Any medical conditions (including hepatic and renal impairment) that would contraindicate the consumption of alcohol or administration of mavoglurant.
7. History of neurological trauma or disease, delirium, or hallucinations, or any significant systemic illness or unstable medical condition.
8. 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.
9. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the alcohol administration.
10. 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.
11. 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.
12. Subjects who have donated blood within the past six weeks.
13. 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
14. Current use of warfarin.
15. Use of any medications that are contraindicated with mavoglurant and alcohol.
16. AST, ALT, total bilirubin >1.5 times upper normal; serum creatinine, >2 times upper normal limit, total bilirubin>1.5 times ULN; Serum creatinine >2.0 times ULN.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo once daily for 7-10 days
200 mg Mavoglurant	Mavoglurant	200 mg mavoglurant once daily for 7-10 days

Primary Outcome Measures

Name	Time	Method
Abnormal Labs and Adverse Events	Day 10	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

Trial Locations

Locations (1)

CMHC, Substance Abuse Center; 🇺🇸 New Haven, Connecticut, United States