Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-50
SponsorYale University
About this trial
The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mavoglurant
Treatment groups
63 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov