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Study on Sodium Oxybate for Reducing Alcohol Consumption in Patients with Alcohol Addiction

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What is this trial about?

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

This clinical trial is focused on studying Alcohol Addiction, a condition where individuals have a strong craving for alcohol and find it difficult to control their drinking. The study is testing a treatment called Sodium Oxybate, which is an oral solution that participants will take by mouth. The purpose of the study is to see if Sodium Oxybate can help reduce alcohol consumption and help individuals maintain abstinence, meaning they stop drinking alcohol altogether.

Participants in the study will be individuals who are dependent on alcohol and have a high or very high risk level of drinking. The study will involve taking the medication or a placebo for a period of time, and researchers will monitor the participants' alcohol consumption. The main goal is to see if there is a reduction in the number of heavy drinking days after three months of treatment.

The study will last for several months, during which participants will have regular visits to check their progress. The researchers aim to gather information on the safety and effectiveness of Sodium Oxybate in helping people with alcohol addiction reduce their drinking and maintain abstinence. This information could be valuable in developing new treatments for alcohol addiction in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    The study begins with an initial visit where the participant provides informed consent for the study and the treatment of personal data.

    Eligibility is confirmed based on criteria such as age, body weight, and current diagnosis of alcohol use disorder.

  2. Step 2

    Baseline assessment

    A comprehensive assessment is conducted to evaluate the participant's medical history, physical condition, and alcohol consumption patterns.

    Participants must have a high or very high drinking risk level (HDRL or VHDRL) and meet other specific criteria.

  3. Step 3

    Treatment initiation

    Participants begin treatment with sodium oxybate, administered as an oral solution known as Alcover.

    The solution is taken orally, with the dosage and frequency determined by the study protocol.

  4. Step 4

    Ongoing monitoring

    Participants attend regular visits to monitor their progress and any side effects.

    The primary goal is to reduce the number of heavy drinking days (HDDs) over a 12-week period.

  5. Step 5

    Final assessment

    At the end of the 12-week treatment period, a final assessment is conducted to evaluate the reduction in alcohol consumption.

    The study measures the average number of HDDs to determine the efficacy of the treatment.

Who can join the trial?

12 criteria

  • Sign an agreement to participate in the study and allow the use of personal data.
  • Be a male or female between 18 and 70 years old.
  • Have a body weight between 60 and 100 kg, with a Body Mass Index (BMI) less than 40. BMI is a measure of body fat based on height and weight.
  • Have a current diagnosis of alcohol use disorder according to the DSM-5. DSM-5 is a manual used by healthcare professionals to diagnose mental disorders.
  • Have high or very high levels of alcohol consumption based on World Health Organization (WHO) criteria. For males, high is more than 60 grams per day, and very high is more than 100 grams per day. For females, high is more than 40 grams per day, and very high is more than 60 grams per day.
  • Have no or mild alcohol withdrawal symptoms, with a CIWA-Ar score less than 10. CIWA-Ar is a scale used to measure the severity of alcohol withdrawal symptoms.
  • Have medical conditions that allow safe participation, confirmed by medical history and physical examination.
  • Have at least 4 heavy drinking days (HDDs) per week in the 4 weeks before the screening visit. HDDs are days when a person drinks a large amount of alcohol.
  • Be able to accurately fill in the Timeline Followback (TFLB) and study-administered scale. TFLB is a method used to assess alcohol consumption.
  • Be able to take the study drug or placebo. A placebo is a substance with no active drug, used in clinical trials for comparison.
  • For subjects with cirrhosis: Have a compensated medical condition, determined by clinical evaluation and psychometric assessment using ANT1, with a cut-off value greater than 15. Cirrhosis is a liver condition, and ANT1 is a test used to assess brain function.
  • For females only: Be postmenopausal for at least one year, surgically sterile, or using an effective method of birth control before the study, during the study, and for two months after the end of treatment. Postmenopausal means having stopped menstruating for at least one year.

Who cannot join the trial?

5 criteria

  • Individuals who are not addicted to alcohol cannot participate.
  • People who are not within the specified age range for the study cannot participate.
  • Individuals who do not meet the specific health conditions required for the study cannot participate.
  • People who are not part of the selected vulnerable population cannot participate.
  • Individuals who do not meet the gender requirements for the study cannot participate.
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Investigated drugs

Sodium Oxybate is being studied for its ability to help people who are dependent on alcohol reduce their drinking and maintain abstinence. The trial aims to see if this medication can effectively lower alcohol consumption in individuals who are at high and very high risk levels for drinking.

What is already known about the treatment

Sodium Oxybate – Sodium Oxybate is administered orally in liquid form. It is currently being studied for its effectiveness in reducing alcohol consumption and maintaining abstinence in individuals with alcohol addiction. The medication is primarily indicated for alcohol dependence, particularly in those with high and very high drinking risk levels. At the molecular level, Sodium Oxybate works by modulating neurotransmitter activity in the brain, which helps to reduce cravings and withdrawal symptoms. It is classified pharmacologically as a central nervous system depressant.

Investigated diseases

Alcohol Use Disorder – This condition is characterized by an inability to control alcohol consumption despite negative consequences. It often involves a strong craving for alcohol, a loss of control over its use, and the development of tolerance, requiring more alcohol to achieve the same effect. Over time, individuals may experience withdrawal symptoms when not drinking, which can include anxiety, tremors, and nausea. The disorder can lead to significant impairments in daily functioning, affecting personal relationships, work, and health. It typically progresses as the individual continues to consume alcohol, often leading to increased consumption and more severe symptoms. The disorder can vary in severity, ranging from mild to severe, depending on the number of symptoms present.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506990-37-00Protocol codeOXYLIFEEstimated enrolment240 patientsSponsorLaboratorio Farmaceutico C.T. S.r.l.

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