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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
C.M.I Dr. Popa Andreea	Bucharest	Romania

Other Sites

Site Name	City	Country	Status
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila	Bucharest	Romania
Bpf Twdyd Mrg Srnoh	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	31.03.2025

Trial locations

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.

Investigated diseases:

Alcohol use disorder

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 ID:

2024-517105-85-00

Protocol code:

SUN2023

NCT ID:

NCT06545916

Trial Phase:

Therapeutic exploratory (Phase II)

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