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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Mavoglurant
DrugThe 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: Mavoglurant 1st / Placebo 2ndExperimental treatment 1 intervention
Group B: Placebo 1st / Mavoglurant 2ndExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change 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).2
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov