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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50AA012870-21 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavoglurant 1st / Placebo 2nd | Experimental | Participants randomized to the Mavoglurant 1st Arm will take a single dose of 200mg mavoglurant in the morning, prior to their 1st lab session. Then after a 5-8 day washout period, participants will have their 2nd lab session where they will take a matching placebo in the morning prior to the 2nd lab session. |
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| Placebo 1st / Mavoglurant 2nd | Experimental | Participants randomized to the Placebo 1st Arm will take a matching placebo in the morning, prior to their 1st lab session. Then after a 5-8 day washout period, participants will have their 2nd lab session where they will take a single dose of 200mg mavoglurant in the morning, prior to their 2nd lab session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavoglurant | Drug | The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of drinks consumed | The number of drinks consumed during the adlib session will be recorded | 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. | Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suchitra Krishnan, PhD | Contact | 203-974-7595 | suchitra.krishnan-sarin@yale.edu | |
| Thomas Liss | Contact | (203)974-7555 | thomas.liss@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center (SAC and SATU) | Recruiting | New Haven | Connecticut | 06511 | United States |
Deidentified individual data will be shared.
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000435 | Alcoholic Intoxication |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06512 | United States |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |