Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-07 @ 11:11 AM
Study NCT ID:
NCT03327792
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2017-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mavoglurant in Alcohol Drinking
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
A Pilot Study on the Safety and Efficacy of Mavoglurant in Alcohol Drinking
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2P50AA012870-21 | NIH | None | https://reporter.nih.gov/quic… | View |