Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-27 @ 10:40 PM
Study NCT ID:
NCT06136195
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2023-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
Status:
RECRUITING
Status Verified Date:
2024-08
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 research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.
Detailed Description:
This project will use a double-blind, placebo-controlled, within-subject design to examine mavoglurant effects on alcohol craving, drinking, and subjective responses. Non-treatment seeking, heavy drinkers with Alcohol Use Disorder (AUD) will undergo 2 lab sessions, which include a Cue Exposure (craving) Paradigm (CEP) and an Alcohol Drinking Paradigm (ADP), as well as 1-week and 1-month follow up appointments. Prior to the first lab session, participants will be randomized to receive either 200 mg of mavoglurant or placebo. For the second lab session, participants will receive the other condition, mavoglurant or placebo, that they did not receive in the first lab session. Each session will be separated by at least a 5-8 day washout period to allow for complete washout of mavoglurant. This is followed by 1-week and 1-month follow up appointments.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2P50AA012870-21 | NIH | None | https://reporter.nih.gov/quic… | View |