Ongoing Clinical Trials for Alcohol Use Disorder
There are currently 8 clinical trials investigating new treatments for Alcohol Use Disorder across Europe. These studies are exploring various medications including psilocybin, cannabidiol, ketamine, and other investigational drugs aimed at reducing alcohol consumption and supporting recovery.
Clinical trial locations
- Denmark
- Study of Single Dose Psilocybin Treatment for Adults with Alcohol Use Disorder
- Study on Semaglutide’s Effect on Reducing Alcohol Intake in Patients with Alcohol Use Disorder and Obesity
- Study on the Effects of Tirzepatide on Reducing Alcohol Intake in Patients with Schizophrenia and Alcohol Use Disorder
- France
- Norway
- Romania
- Sweden
Study of Single Dose Psilocybin Treatment for Adults with Alcohol Use Disorder
This study is taking place in Denmark and explores whether a single dose of psilocybin capsules can help reduce alcohol consumption over a 12-week period. The trial compares psilocybin to a placebo to determine if it can decrease the number of heavy drinking days.
Main inclusion criteria: Participants must be between 20 and 70 years old, weigh between 60 and 95 kilograms, and have a confirmed diagnosis of Alcohol Use Disorder according to both DSM-5 and ICD-10 classifications. They must score 15 or higher on the Alcohol Use Disorder Identification Test and have had at least 5 heavy drinking days in the past 28 days, where heavy drinking is defined as more than 60 grams of alcohol per day for men or more than 48 grams for women.
Main exclusion criteria: People with severe psychiatric disorders such as schizophrenia, bipolar disorder, or severe depression cannot participate. Those with a history of suicide attempts, current suicidal thoughts, serious medical conditions, seizures, severe liver or kidney disease, pregnancy or breastfeeding, or substance use disorders involving drugs other than alcohol are also excluded.
Focus and goal: The trial aims to test whether a single 25mg dose of PEX010 Psilocybin Capsules can reduce heavy drinking days and overall alcohol consumption. The study includes brain scanning through fMRI, blood tests to measure medication levels, and regular assessments of drinking patterns, cravings, and quality of life over 12 weeks.
Investigational drug: Psilocybin is a naturally occurring psychedelic compound from mushrooms that works by activating serotonin receptors in the brain. It is administered as a single oral dose under medical supervision and may help break established patterns of addictive behavior by altering neural connectivity and promoting new perspectives on alcohol consumption.
Study on Cannabidiol as an Add-On Treatment for Patients with Severe Alcohol Use Disorder During Inpatient Alcohol Cessation
This French trial investigates whether cannabidiol can help patients maintain abstinence from alcohol during and after a hospital stay for alcohol cessation. The study runs for approximately six weeks, starting during hospitalization and continuing for a month after discharge.
Main inclusion criteria: Patients must be hospitalized for a planned alcohol cessation program, be between 18 and 75 years old, meet DSM-5 criteria for severe Alcohol Use Disorder, be willing to participate, have current social insurance, and females of childbearing age must use effective birth control during treatment and for seven days after.
Main exclusion criteria: The specific exclusion criteria focus on ensuring participants have severe Alcohol Use Disorder as defined by DSM-5 guidelines.
Focus and goal: The study evaluates whether Arvisol 150mg cannabidiol tablets can help patients stay away from alcohol for a longer period after hospital discharge. Participants undergo daily assessments during their inpatient stay, including self-reports of abstinence, symptom checklists, and evaluations of withdrawal and craving levels. After discharge, weekly outpatient visits continue through week 6, with ongoing urinary assessments to check for alcohol use.
Investigational drug: Cannabidiol is a compound from the cannabis plant that does not cause a “high” but may support recovery. It is administered orally as a tablet and interacts with the body’s endocannabinoid system, which may help regulate mood and cravings.
Study on Ketamine and Midazolam for Adults with Depression and Alcohol Use Disorder
This Norwegian study examines how effective ketamine is in treating depression in adults who also have alcohol use disorder and are receiving addiction therapy. The trial compares ketamine with a placebo medication called midazolam.
Main inclusion criteria: Participants must be between 18 and 65 years old, have at least moderate depression without psychotic features, have alcohol dependence as their primary substance use disorder, and be admitted to the hospital for inpatient addiction therapy at University Hospital of North Norway.
Main exclusion criteria: Individuals not diagnosed with both depression and alcohol use disorder cannot participate. Those outside the specified age range or considered part of a vulnerable population are also excluded.
Focus and goal: The study measures changes in depression symptoms using the MADRS scale from the start to within three days after the final treatment session. Secondary outcomes include changes in alcohol craving, consumption, neurocognitive function, and any adverse reactions. Follow-up assessments evaluate alcohol consumption changes from three months before admission to six months after treatment.
Investigational drug: Ketamine is administered through intravenous infusion and works by blocking NMDA receptors in the brain, which are involved in mood regulation. It is known for its rapid-acting antidepressant effects, especially when traditional treatments have not worked.
Study on the Effects of Sunobinop on Reducing Alcohol Consumption in Patients with Moderate to Severe Alcohol Use Disorder Seeking Treatment
This Romanian trial tests whether Sunobinop can reduce the percentage of heavy drinking days in people with moderate to severe Alcohol Use Disorder. The study lasts eight weeks, with participants taking medication daily.
Main inclusion criteria: Men and women aged 18 or older with moderate or severe Alcohol Use Disorder who are currently seeking treatment. Participants must have had 4 or more heavy drinking days in each of the 4 weeks before the study starts. A heavy drinking day is defined as 4 or more standard drinks for women or 5 or more for men. Men with female partners who can become pregnant must use condoms, and women of childbearing potential must use reliable birth control during the study and for 30 days after.
Main exclusion criteria: Patients with a current diagnosis of Alcohol Use Disorder as defined by specific criteria cannot participate.
Focus and goal: The study evaluates whether Sunobinop tablets (0.5 mg, 1 mg, or 2 mg) can effectively reduce heavy drinking days and alcohol cravings. Participants complete a daily electronic diary tracking alcohol consumption and cravings, and attend regular clinic visits for monitoring and safety assessments.
Investigational drug: Sunobinop is an investigational medication taken orally once daily. It targets specific pathways in the brain involved in alcohol craving and consumption. The medication is still in Phase 2 clinical trials, meaning it is being tested for effectiveness and safety in humans.
Study on the Effects of Tirzepatide on Reducing Alcohol Intake in Patients with Schizophrenia and Alcohol Use Disorder
This Danish study explores whether tirzepatide can help reduce alcohol consumption in patients who have both schizophrenia and alcohol use disorder. The trial lasts up to 26 weeks and includes regular assessments and brain imaging studies.
Main inclusion criteria: Patients must provide informed consent, have diagnoses of both alcohol dependence and alcohol use disorder according to ICD-10 and DSM-5, as well as schizophrenia spectrum disorder. They must score greater than 15 on the Alcohol Use Disorder Identification Test, have a BMI of 23 or higher, be between 18 and 70 years old, and have had 4 or more heavy drinking days within a 21-day period during the 28 days before the study starts.
Main exclusion criteria: Patients without diagnoses of both schizophrenia and alcohol use disorder, those outside the age range, pregnant or breastfeeding women, those currently in another clinical trial, and those with severe allergic reactions to study medications cannot participate.
Focus and goal: The study monitors changes in alcohol consumption, specifically the number of heavy drinking days, along with alcohol cravings, overall consumption, and quality of life. It also evaluates effects on schizophrenia symptoms and other health parameters. Some participants undergo fMRI scans to study brain activity related to alcohol cues.
Investigational drug: Tirzepatide is administered as a subcutaneous injection once weekly using a pre-filled pen. Originally designed to help manage blood sugar levels in type 2 diabetes, it mimics hormones that regulate blood sugar and appetite, which may also influence alcohol consumption behaviors. It is classified as a dual agonist targeting receptors involved in glucose and appetite regulation.
Study on Oxytocin for Improving Behavior in Young Adults with Alcohol Use Disorder
This Swedish trial investigates whether oxytocin nasal spray can increase prosocial behavior in young adult males with high alcohol use. The study involves two short sessions where participants complete tasks measuring social behavior and other responses.
Main inclusion criteria: Participants must be males between 18-24 years old, able to give informed consent and follow study procedures, meet criteria for at least moderate Alcohol Use Disorder in the past 12 months according to the MINI Neuropsychiatric Interview, and score at least 8 points on the Alcohol Use Disorder Identification Test.
Main exclusion criteria: Females, individuals under 18 or over 65, and those considered part of a vulnerable population are not eligible.
Focus and goal: The study measures prosocial behavior using the dictator game approximately 35-75 minutes after administration. Additional assessments between 76-120 minutes after administration measure impulsivity, emotion recognition, social learning, and alcohol craving. The goal is to understand if oxytocin can improve social interactions in young adults with high alcohol consumption.
Investigational drug: Oxytocin is a naturally occurring hormone administered as a nasal spray at 6.7 micrograms per dose. Often called the “love hormone,” it plays a role in social bonding and works by binding to oxytocin receptors in the brain, which can influence social bonding and stress responses.
Study on Psilocybin for Patients with Alcohol Use Disorder and Depression Symptoms
This French study explores the feasibility of using psilocybin as a treatment for individuals with alcohol use disorder who also experience depression symptoms. Participants receive two psilocybin sessions with the trial expected to continue until early 2026.
Main inclusion criteria: Patients must have a confirmed diagnosis of severe alcohol use disorder according to DSM-5, a Beck Depression Inventory score of 14 or higher, have consumed their last drink between 60 and 14 days before the inclusion visit, have had at least one heavy drinking day during the last drinking period, provide informed and signed consent, be insured or a beneficiary of a health insurance plan, and be at least 18 years old.
Main exclusion criteria: Patients with a history of alcohol use disorder or depressive symptoms related to alcohol use disorder may be excluded.
Focus and goal: The study assesses feasibility by monitoring the number of participants who complete both psilocybin sessions, changes in drinking habits, and shifts in depression symptoms. It includes questionnaires, blood samples, and analysis of brain activity and biological markers. Integration sessions the day after each psilocybin administration help participants process their experiences, with follow-up assessments at weeks 3, 6, and 12.
Investigational drug: Psilocybin is administered orally in capsule form. It affects serotonin receptors in the brain, which can alter mood and perception. The substance causes changes in perception, mood, and thought, which is why researchers are interested in its potential benefits for mental health conditions involving both depression and alcohol use.
Study on Semaglutide’s Effect on Reducing Alcohol Intake in Patients with Alcohol Use Disorder and Obesity
This Danish trial examines whether semaglutide can reduce alcohol intake in people who have both Alcohol Use Disorder and obesity. The study runs for 26 weeks and monitors changes in drinking patterns, body weight, and other health indicators.
Main inclusion criteria: Participants must provide informed consent, have a diagnosis of alcohol dependence according to ICD-10 and alcohol use disorder according to DSM-5, score greater than 15 on the Alcohol Use Disorder Identification Test, have a BMI of 30 or higher, be between 18 and 70 years old, and have engaged in heavy drinking defined as more than 6 days with consumption over 4 units for women or 5 units for men during a consecutive 30-day period within 40 days before the study starts.
Main exclusion criteria: Patients without a diagnosis of Alcohol Use Disorder, those without comorbid obesity, individuals outside the specified age range, and members of vulnerable populations cannot participate.
Focus and goal: The study determines if semaglutide can effectively reduce alcohol consumption over 26 weeks. It monitors changes in the number of heavy drinking days, total alcohol consumed, alcohol-free days, body weight, blood pressure, and other health indicators through regular follow-up visits and assessments using the Timeline Followback method.
Investigational drug: Semaglutide is a GLP-1 receptor agonist administered as a subcutaneous injection once weekly using a pre-filled pen. The dosage is gradually increased to a maximum of 2.4 mg. It mimics a natural hormone that helps control appetite and blood sugar levels, and researchers are investigating whether it can also help reduce alcohol cravings by affecting brain areas that control addiction.
Summary
The eight ongoing clinical trials for Alcohol Use Disorder demonstrate diverse approaches to treatment across Europe. Denmark leads with three trials, followed by France with two, while Norway, Romania, and Sweden each host one trial.
A notable trend is the investigation of psychedelic compounds, with two trials exploring psilocybin in Denmark and France. Several studies focus on patients with co-occurring conditions, particularly depression, schizophrenia, and obesity, reflecting the complex nature of alcohol use disorder. The trials employ various medication classes, from traditional psychiatric medications like ketamine to newer metabolic drugs like semaglutide and tirzepatide, and natural compounds including cannabidiol and oxytocin.
Most studies measure outcomes related to reducing heavy drinking days and overall alcohol consumption, with treatment durations ranging from short two-session interventions to 26-week programs. The geographical distribution suggests strong research activity in Scandinavian countries, particularly Denmark, while France and Romania also contribute to advancing treatment options for this challenging condition.
