Alcohol ConsumptionPhase 1NCT06136195
Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
A Phase 1 study testing Mavoglurant in people with Alcohol Consumption and Heavy Drinker, run by Yale University at 2 sites in United States.
Trial summary
The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Alcohol Consumption, Heavy Drinker, Alcohol Use Disorder (AUD)
- What is being tested?
- Mavoglurant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2024to 31 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).
- Ability to read English at 6th grade level or higher.
- Meet DSM-V criteria for moderate or severe Alcohol Use Disorder (AUD).
- Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the Alcohol Drinking Paradigm (ADP).
Who cannot join
- Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.
- Meet current Diagnostic and Statistical Manual v.5 (DSM-V) criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.
- Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines and barbiturates.
- Psychotic or other severe psychiatric disorders as determined by clinical evaluation (Structured Clinical Interview for DSM-V; SCID). Note that if a subject endorses any harm/risk behaviors (e.g. suicidal/homicidal risk) a licensed clinician will be consulted immediately.
- Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.
- Medical conditions that would contraindicate the consumption of alcohol or use of mavoglurant.
Show all 15Show fewer
- Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) >3 times upper limit of normal (ULN); alanine aminotransferase (ALT) > 3 times ULN; total bilirubin >1.5 times ULN; serum creatinine >2.0 times ULN.
- Neurological trauma or disease, delirium or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and Principal Investigator, may put the patient at risk because of participation in the study.
- Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.
- Women who are pregnant or nursing.
- Participants who refuse to use a reliable method of birth control.
- Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.
- Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.
- Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.
- Subjects who have donated blood within the past 6 weeks.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Connecticut Mental Health Center (SAC and SATU)
New Haven, Connecticut, 06511
Thomas B Liss, BS, 203 974 5767, thomas.liss@yale.edu
Nicolas Franco, BA, 203 974-5759, nicolas.franco@yale.edu
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06512
Suchitra Krishnan-Sarin, PhD, (203) 974-7595, Suchitra.krishnan-sarin@yale.edu
Thomas Liss, (203)974-7555, thomas.liss@yale.edu
About this study
The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.
Read the 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.
- Being tested
- Mavoglurant
- Medical subject headings
- Alcohol Drinking, Alcoholic Intoxication, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavoglurantDrug
Also called STP7
The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mavoglurant |
| 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. Receives: Drug: Mavoglurant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of drinks consumed
The number of drinks consumed during the adlib session will be recorded
Measured: 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.
Measured: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jul 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Suchitra Krishnan-Sarin, Yale University
- Investigators
- Suchitra Krishnan, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136195
- Sponsor's protocol ID
- 2000029675
- Other IDs
- 2P50AA012870-21
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
- ClinicalTrials.gov ID
- NCT06136195
- Acronym / sponsor ID
- 2000029675
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mavoglurant 1st / Placebo 2nd | Experimental | Drug: MavoglurantParticipants 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. |
| Placebo 1st / Mavoglurant 2nd | Experimental | Drug: MavoglurantParticipants 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).
- Ability to read English at 6th grade level or higher.
- Meet DSM-V criteria for moderate or severe Alcohol Use Disorder (AUD).
- Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the Alcohol Drinking Paradigm (ADP).
Key exclusion criteria (15 listed)
- Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.
- Meet current Diagnostic and Statistical Manual v.5 (DSM-V) criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.
- Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines and barbiturates.
- Psychotic or other severe psychiatric disorders as determined by clinical evaluation (Structured Clinical Interview for DSM-V; SCID). Note that if a subject endorses any harm/risk behaviors (e.g. suicidal/homicidal risk) a licensed clinician will be consulted immediately.
- Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MavoglurantAlso: STP7The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets. | Drug | Mavoglurant 1st / Placebo 2nd, Placebo 1st / Mavoglurant 2nd |
Primary outcome
Change in the number of drinks consumed
Time frame: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).
The number of drinks consumed during the adlib session will be recorded
Change in craving for alcohol
Time frame: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suchitra Krishnan, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mavoglurant in people with Alcohol Consumption and Heavy Drinker, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suchitra Krishnan, PhD (203-974-7595, suchitra.krishnan-sarin@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of drinks consumed (time frame: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.