Efficacy and safety of Sodium Oxybate in reducing alcohol consumption and maintaining abstinence in alcohol-dependent subjects with high and very high drinking risk level

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506990-37-00

Acronym

OXYLIFE

Enrollment

240

Registered

2023-09-29

Start date

2021-07-13

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol addiction

Brief summary

The primary end point of the study is the reduction of HDDs as measured by the average number of HDDs after 3 months of treatment (Visit 7, week 12).

Interventions

DRUGOral Solution. Each bottle contains 10 ml of solution with the following composition: Sorbitol liquid (70%)

DRUGMethyl parahydorxybenzoate

DRUGPropyl parahydroxybenzoate

DRUGSaccharin Sodium

DRUGSour black cherry flavouring

DRUGPurified water.

DRUGALCOVER 175 mg/ml soluzione orale

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary end point of the study is the reduction of HDDs as measured by the average number of HDDs after 3 months of treatment (Visit 7, week 12).	—

Countries

France, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026