Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effects of Sunobinop on Reducing Alcohol Consumption in Patients with Moderate to Severe Alcohol Use Disorder Seeking Treatment

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Sunobinop on individuals diagnosed with Alcohol Use Disorder (AUD). AUD is a condition where a person has difficulty controlling their alcohol consumption, leading to significant health and social problems. The study aims to see if Sunobinop can help reduce the number of days participants engage in heavy drinking. The trial will compare the effects of Sunobinop with a placebo, which looks like the medication but does not contain the active ingredient.

Participants in the study will be randomly assigned to receive either Sunobinop or the placebo. The medication will be taken in tablet form, with doses of 0.5 mg, 1 mg, or 2 mg, depending on the group assignment. The study will last for a period of eight weeks, during which participants will take the medication daily. Throughout the study, participants will be asked to keep a daily diary of their alcohol consumption and attend regular clinic visits for monitoring.

The purpose of this study is to evaluate whether Sunobinop can effectively reduce the percentage of heavy drinking days in individuals with moderate to severe Alcohol Use Disorder. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for those struggling with AUD.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit at the clinic. During this visit, you will undergo assessments to confirm your eligibility for the trial. This includes a review of your medical history and a structured interview to confirm your diagnosis of moderate to severe alcohol use disorder.

  2. Step 2

    Randomization

    After eligibility is confirmed, you will be randomly assigned to one of the study groups. You may receive either the active medication, sunobinop, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

  3. Step 3

    Medication administration

    You will take the assigned tablet orally once a day. The dosage of sunobinop may be 0.5 mg, 1 mg, or 2 mg, depending on the group you are assigned to. The duration of the medication administration will be determined by the study protocol.

  4. Step 4

    Daily diary

    You will be required to complete a daily electronic diary. This diary will help track your alcohol consumption and any cravings you experience. It is important to fill out the diary consistently and accurately.

  5. Step 5

    Follow-up visits

    Throughout the study, you will attend regular follow-up visits at the clinic. These visits are necessary to monitor your progress, assess any side effects, and ensure your safety. The frequency of these visits will be outlined in the study schedule provided to you.

  6. Step 6

    Final assessment

    At the end of the study period, you will undergo a final assessment. This will include a review of your alcohol consumption patterns and any changes in your condition. The results will help determine the effectiveness of sunobinop in reducing heavy drinking days.

Who can join the trial?

8 criteria

  • Men and women who are 18 years or older.
  • Have a diagnosis of moderate or severe alcohol use disorder. This means a pattern of drinking that leads to significant problems in daily life, confirmed by a specific interview process.
  • Currently looking for treatment for alcohol use disorder.
  • Have had 4 or more heavy drinking days in each of the 4 weeks before the start of the study. A heavy drinking day is when a woman drinks 4 or more standard drinks, or a man drinks 5 or more standard drinks in one day. A standard drink is about 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of distilled spirits.
  • Men with a female partner who can become pregnant must agree to use condoms or have had a vasectomy (a procedure that makes a man unable to father children) during the study and for 30 days after.
  • Women can participate if they are not pregnant, not breastfeeding, and meet one of the following:
    • Cannot become pregnant (for example, have had a hysterectomy, which is surgery to remove the uterus, or are at least one year past menopause, which is when periods stop permanently).
    • If they can become pregnant, they must agree to use a reliable form of birth control during the study and for 30 days after.
    • Willing to follow the study rules, which include taking the study medication as instructed, completing a daily electronic diary, and attending clinic visits. Must also be able to read and understand questionnaires.

Who cannot join the trial?

1 criterion

  • Patients with a current diagnosis of Alcohol Use Disorder (AUD) cannot participate. This means if you have been diagnosed with a condition where you have trouble controlling your alcohol use, you are not eligible.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Sunobinop (V117957) is a medication being studied to see if it can help people who have a moderate to severe alcohol use disorder. This means that the medication is being tested to find out if it can help reduce the number of days people drink heavily. The study is also looking at whether this medication can help reduce the craving for alcohol. People who are part of this study are those who are seeking treatment for their alcohol use disorder. The goal is to see if taking Sunobinop can make a difference in their drinking habits and cravings compared to not taking it.

What is already known about the treatment

Sunobinop – Sunobinop is a medication currently being studied for its potential to help people with moderate to severe alcohol use disorder (AUD) reduce their alcohol consumption and cravings. It is administered orally in the form of a pill. The medication is still in the clinical trial phase, specifically a Phase 2 study, which means it is being tested for its effectiveness and safety in humans. Sunobinop works by targeting specific pathways in the brain that are involved in the craving and consumption of alcohol, although the exact molecular mechanism is still under investigation. It is classified as an investigational drug, meaning it is not yet approved for general medical use.

Investigated diseases

Alcohol Use Disorder – Alcohol Use Disorder is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. It often begins with occasional drinking that gradually increases in frequency and quantity. Over time, individuals may develop a tolerance, needing more alcohol to achieve the same effects. As the disorder progresses, individuals may experience withdrawal symptoms when not drinking. The condition can lead to significant disruptions in daily life, affecting relationships, work, and overall health. It is a chronic condition that can vary in severity, with some individuals experiencing periods of remission and relapse.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517105-85-00Protocol codeSUN2023Estimated enrolment200 patients

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.