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Evaluation of the Efficacy of Sodium Oxybate in the Long-term Maintenance of Abstinence in Alcoholic Patients

NCT04648423 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2020-12-04

No results posted yet for this study

Summary

Additional pharmacotherapies in the treatment of alcohol dependence are needed. Sodium oxybate showed efficacy in the maintenance of abstinence in alcohol-dependent patients in several small randomized trials of short duration. The aim of the present phase III/IV study is to confirm in a randomized-controlled study the efficacy and safety of oral sodium oxybate in the maintenance of abstinence.

Conditions

  • Alcohol Use Disorder (AUD)
  • Alcohol Dependence

Interventions

DRUG

Sodium Oxybate

solution for oral administration

DRUG

Placebo

solution for oral administration

Sponsors & Collaborators

  • Laboratorio Farmaceutico Ct S.r.l.

    lead INDUSTRY

Principal Investigators

  • Roberto Cacciaglia · Laboratorio Farmaceutico C.T.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-23
Primary Completion
2011-03-31
Completion
2012-01-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648423 on ClinicalTrials.gov