Sunobinop for Alcohol Use Disorder
Sunobinop
+ Placebo to match sunobinop
Alcohol Drinking+5
+ Alcoholism
+ Behavior
Treatment Study
Summary
Study start date: October 14, 2024
Actual date on which the first participant was enrolled.This study aims to determine if a medication named Sunobinop can help reduce alcohol consumption in individuals diagnosed with moderate to severe alcohol use disorder. The study focuses on people who are actively seeking treatment for their alcohol use, which is important because finding effective treatments can help improve the quality of life for those struggling with this condition. By potentially offering a new way to manage alcohol use, the study could provide an important tool for individuals and healthcare providers. Participants in this study will be randomly assigned to receive either the medication Sunobinop or a placebo, which is a substance with no active ingredients, to compare the effects on their alcohol consumption. This is done in a "double-blind" manner, meaning neither the participants nor the researchers know who is receiving the actual medication, ensuring unbiased results. The study observes how well Sunobinop works in reducing alcohol intake and monitors any side effects to ensure the treatment is safe. This careful approach helps researchers understand if Sunobinop can be a beneficial treatment for those with alcohol use disorder.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Key Inclusion Criteria include: * Male and female age ≥18 years. * Diagnosis of moderate or severe alcohol use disorder. * Currently seeking treatment for alcohol use disorder. * Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit. Key Exclusion Criteria include: * Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine. Other protocol-specific inclusion and exclusion criteria may apply.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Ohio Clinical Trials
Columbus, United StatesInquest Clinical Research
Baytown, United StatesCebis Usa, Llc
Houston, United States