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New treatment option for Alcohol Consumption
Official title Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
ClinicalTrials.gov ID: NCT06136195
What this study is testing
What is Mavoglurant?
Mavoglurant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alcohol consumption.
Also referred to as STP7.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 50
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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...
- 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 people reduce their...
- Women who are pregnant or nursing.
- Participants who refuse to use a reliable method of birth control.
- people who report disliking spirits will be excluded because hard liquor will be provided during the ADP.
- people 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 people who are misrepresenting their drinking history.
- people who have donated blood within the past 6 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.