Evaluation of Sodium Oxybate for Reducing Alcohol Consumption and Sustaining Abstinence in Patients with Alcohol Dependence at High Drinking Risk Levels
- Trial ID
- 2023-506990-37-00
- Protocol
- OXYLIFE
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **efficacy** of **Sodium Oxybate** in reducing alcohol consumption among individuals with alcohol addiction who are classified as having a high or very high drinking risk level. This will be measured by the number of heavy drinking days (HDDs). The clinical relevance of this objective lies in addressing the need for effective pharmacological interventions to reduce alcohol intake and support abstinence in patients with significant drinking risk, thereby potentially improving health outcomes and quality of life for this population.
Participants
The clinical trial focuses on **alcohol addiction** and involves a study population comprising both male and female participants aged between 18 and 70 years. The participants are alcohol-dependent individuals who are regular drinkers with high or very high daily rates of alcohol consumption, as defined by the World Health Organization criteria. The trial includes individuals with a body weight between 60 and 100 kg and a BMI of less than 40. Participants must have a current diagnosis of alcohol use disorder according to the DSM-5 and exhibit no or mild alcohol withdrawal symptoms. The study population is selected from individuals who have not previously received Alcover treatment and have at least four heavy drinking days per week in the four weeks prior to the screening visit. The trial does not specify the total number of participants, as this information was not provided by the sponsor. Participants must be able to complete study-related assessments and adhere to the study drug or placebo regimen. Females in the study are required to be postmenopausal, surgically sterile, or practicing effective birth control. The trial also includes vulnerable populations, ensuring that medical conditions are compatible with safe enrollment as confirmed by medical history and physical examination.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** and safety of **sodium oxybate** in reducing alcohol consumption and maintaining abstinence in individuals with alcohol addiction. This study is a randomized, double-blind, controlled trial, which will span a total duration of approximately four years, with an estimated end date of December 31, 2024. Participants will be randomly assigned to receive either the active treatment, **sodium oxybate**, or a placebo, both administered as an oral solution. The trial will include several key visits: an initial screening visit, multiple follow-up visits, and a final end-of-study visit.
The inclusion visit, or screening visit, will determine participant eligibility based on specific criteria, such as age, body weight, and current diagnosis of alcohol use disorder according to DSM-5. Participants must also demonstrate a high or very high drinking risk level (DRL) as defined by WHO criteria. Following successful screening, participants will be enrolled and begin the treatment phase, which will last for a maximum of 14 days. The primary endpoint of the study is the reduction in heavy drinking days (HDDs) as measured after three months of treatment, specifically at Visit 7, which occurs at week 12.
Throughout the trial, participants will attend regular follow-up visits to monitor their progress and ensure safety. These visits will include assessments of alcohol consumption, physical examinations, and the completion of study-administered scales. The end-of-study visit will conclude the trial for each participant, during which final assessments will be conducted. Participant involvement is expected to last for the duration of the treatment period and follow-up assessments, with conditions for early termination including significant adverse events or non-compliance with study protocols. The trial aims to provide valuable insights into the potential benefits of **sodium oxybate** for individuals struggling with alcohol addiction.
Treatment
The clinical trial involves the administration of **Sodium Oxybate**, marketed under the name ALCOVER, which is an **oral solution** with a concentration of 175 mg/ml. This experimental medication is intended for oral use and is provided by LABORATORIO FARMACEUTICO C.T. S.R.L. The maximum daily dose of Sodium Oxybate is 5.25 grams, with a total maximum dose of 477.25 grams over a treatment period of 14 days. The active substance, Sodium Oxybate, is chemically derived and is also known by synonyms such as Sodium Salt of Gamma-Hydroxybutyric Acid and Sodium Oxybutyrate. The administration schedule and participant compliance are monitored to ensure adherence to the dosing regimen.
The study also includes a **placebo** treatment, which is an oral solution containing no active pharmaceutical ingredients. Each bottle of the placebo solution contains 10 ml of a mixture composed of Sorbitol liquid (70%), Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Saccharin Sodium, sour black cherry flavoring, and purified water. The placebo is used to provide a comparator for evaluating the efficacy and safety of the experimental treatment. The placebo is administered in a manner consistent with the experimental medication to maintain blinding and ensure the integrity of the trial results.
Efficacy
The efficacy of **Sodium Oxybate** in reducing alcohol consumption and maintaining abstinence in alcohol-dependent subjects will be assessed through a clinical trial. The primary endpoint for evaluating efficacy is the reduction in the number of heavy drinking days (HDDs). This will be measured by calculating the average number of HDDs after three months of treatment, specifically at Visit 7, which corresponds to week 12 of the trial.
The trial will involve alcohol-dependent subjects with high and very high drinking risk levels (HDRL and VHDRL). The primary objective is to demonstrate the efficacy of Sodium Oxybate in reducing alcohol consumption among these subjects. The assessment will be conducted using validated scales and patient-reported outcomes to ensure accurate and reliable data collection. The trial is designed to provide a comprehensive evaluation of the treatment's impact on alcohol consumption patterns over the specified period.
Inclusion and Exclusion Criteria
Inclusion Criteria
- The study population will be enrolled among alcohol-dependent Subjects afferent to the centers. Alcohol-dependent Subjects regular drinkers of alcoholic beverages, with HDRL and VHDRL of alcohol consumption, naïve for Alcover treatment high-risk alcohol consumption will be considered for the enrolment in the present study. All the below inclusion criteria must be fulfilled at Visit 1, by each Subject to be included in the trial: 1. Signature of Informed Consent for the study and for treatment of personal data 2. Male or female of any ethnic group between 18- and 70 -years old 3. Body weight between 60 and 100 kg with a BMI＜ 40 4. Current diagnosis of alcohol use disorder according to the DSM-5 5. High or very high DRL of alcohol consumption based on WHO criteria (HDRL:> 60 g / day in males and> 40 g / day in females; VHDRL:> 100 g / day in males and> 60 g / day in females) 6. No or mild alcohol withdrawal symptoms, defined as CIWA-Ar score < 10 7. Medical conditions compatible with the safe enrollment as confirmed by medical history and physical examination 8. At least 4 HDDs per week in the 4 weeks prior to the screening visit 9. Ability/possibility to efficacy fill in the TFLB and study administered scale 10. Ability/possibility to assume the study drug/placebo 11. Subjects with cirrhosis only: compensated medical condition determined based on the clinical evaluation and psychometric assessment as measured using ANT1 (cut-off value >15) 12. Females only: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry, throughout the study, and for two months after the end of treatment
Exclusion Criteria
- A Subject who met at least one of the following conditions is not eligible and should not be addressed to randomization and treatment phase: 1. Use of Sodium Oxybate during the three months prior to randomitation 2. Current diagnosis of substance dependence other than alcohol and nicotine 3. Lifetime diagnosis of schizophrenia, bipolar disorders, or other psychoses; lifetime diagnosis of Major Depression and history of attempted suicide. 4. History of epilepsy or alcohol-related seizures 5. Positive urine test for cocaine, opiates, methadone at any time during the study. 6. Current participation to another study or participation to an interventional study conducted during 3 months prior to randomization. 7. Females only: breast-feeding and/or positive urine pregnancy test at any time during the study. 8. Severe diseases and/or medical conditions, both acute and chronic, which in the opinion of the investigator jeopardize patient safety, including respiratory depression, liver diseases (e.g. acute hepatitis), decompensated cirrhosis. 9. Presence of particular social condition that, at the investigator judgement, may interfere with the proper study conduct (i.e. subject social marginalisation, Homeless condition, known history of previous crimes related to sexual abuse, drug dealing, etc) 10. Patients with porphyria 11. History of current epileptic syndrome with the exception of neonate convulsions. Patients with epileptic episodes due to alcohol withdrawal are also excluded 12. Known medical history of succinic semialdehyde dehydrogenase deficiency 13. Any significant cerebral vascular and/or cardiovascular disease (e.g., unstable angina pectoris at rest or for minimal effort, acute myocardial infarction within the last 3 months, hearth failure NYHA class II-IV) 14. Any neurological or psychiatric disorders resulting in disorientation, memory impairment, inability to report accurately (for instance Alzheimer’s disease and any other dementia) 15. Concomitant use of psychotropic medications including antiepileptic agents that cannot be discontinued; any medication that may have an effect on alcohol consumption, including baclofen, naltrexone, acamprosate, nalmefene, alcohol dehydrogenase inhibitors, topiramate, gabapentin, ondansetron, benzodiazepines, opioid analgesics, dopamine/norephinefrine reuptake inhibitors. 16. Subjects requiring a structured psychotherapy 17. Hypersensitivity to the active substance or to any of the excipients. 18. Female subjects not willing to undergo to an adequate contraception method for the study duration.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Recruiting | 15 Sept 2020 | 50 |
 Italy | Recruiting | 15 Sept 2020 | 140 |
 Poland | Recruiting | 15 Sept 2020 | 50 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
ALCOVER 175 mg/ml soluzione orale | Test | SOLUZIONE ORALE | ORAL USE | 5.25 | 14 | PRD928213 |
Oral Solution. Each bottle contains 10 ml of solution with the following composition: Sorbitol liquid (70%), Methyl parahydorxybenzoate, Propyl parahydroxybenzoate, Saccharin Sodium, Sour black cherry flavouring, Purified water. | Placebo | N/A | — | — | — | N/A |