The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
63
The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.
Connecticut Mental Health Center (SAC and SATU)
New Haven, Connecticut, United States
RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGChange in the number of drinks consumed
The number of drinks consumed during the adlib session will be recorded
Time frame: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).
Change in craving for alcohol
The Cue Exposure Paradigm (CEP) is used to measure craving for alcohol. The task uses a questionnaire that is in the form of a Visual Analog Scale (VAS). The endpoints will be marked with a 0 on the left indicating no craving and a 20 on the right indicating severe craving. Participants will indicate how strong they are craving to drink alcohol. The VAS takes 2-3 minutes to complete.
Time frame: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).
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