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

NCT04648423 | Completed Phase 4

• 1 other identifier: GHBCR00/2
• Study Type: interventional
• Target: 314
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

alcoholism; alcohol; alcohol dependence; relapse prevention

Outcome Measures

Primary Outcomes (1)

• Cumulative Abstinence Duration (CAD)

  to demonstrate that sodium oxybate is superior to placebo in the CAD during the treatment period.

  6-month treatment period

Secondary Outcomes (11)

• CAD stratified

  6-month treatment period

• Assessment of the exposure-corrected CAD

  6-month treatment period

• CAD during the whole study

  12 months: 6-month treatment period + 6-month follow-up

• Proportion of abstinent patients

  12 months: 6-month treatment period + 6-month follow-up

• Time to the first relapse

  6-month treatment period

Study Arms (2)

sodium oxybate

EXPERIMENTAL

Sodium oxybate solution for oral administration (175 mg/mL). Dose (body weight ≤ 65 kg): 19.0 mL daily, in 3 administrations, for 6 months Dose (body weight \> 65 kg): 22.5 mL daily, in 3 administrations, for 6 months

Drug: Sodium Oxybate

placebo

PLACEBO COMPARATOR

Placebo solution for oral administration. Dose (body weight ≤ 65 kg): 19.0 mL daily, in 3 administrations, for 6 months Dose (body weight \> 65 kg): 22.5 mL daily, in 3 administrations, for 6 months

Drug: Placebo

Interventions

Sodium Oxybate DRUG

solution for oral administration

Also known as: gamma-hydroxy butyrate (GHB)

sodium oxybate

Placebo DRUG

solution for oral administration

placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The following subjects were recruited:
• males and females;
• of any ethnic group;
• age between 21 and 75 years at recruitment;
• documented alcohol dependency before weaning detected according to the CAGE instrument, classified according to the DSM-IV and ICD-10 and severity rated according to the MALT instrument;
• classified according to Lesch typology;
• having successfully undergone a detoxification program, encompassing a 10-day treatment period and a subsequent 10-day untreated follow-up;
• with a responsible relative or caregiver;
• having issued the informed consent.

You may not qualify if:

• subjects who did not quit alcohol drinking after the detoxification period;
• subjects with history of epilepsy or epileptics seizures not properly controlled by established anti-epileptic treatment;
• subjects with dependence from narcotics or other drugs of abuse;
• subjects without a stable address;
• subjects without a reference relative or caregiver;
• subjects with renai failure (blood creatinine \>2.5 mg/dL and/or documented proteinuria \>500 mg/day);
• subjects with heart failure or severe respiratory failure;
• subjects with hepatic encephalopathy stage lI-IV;
• subjects with severe psychiatric disorders requiring treatment with psychoactive medications (excluding short-term benzodiazepine treatments);
• subjects under treatment with clonidine, disulfiram (after the end of the detoxification period), haloperidol, bromocryptine, serotonine re-uptake inhibitors or other serotoninergic agents;
• female subjects who cannot assure not to become pregnant during the 7-month period covering treatment and the first treatment-free month of follow-up;
• documented pre-existent hypersensitivity to GHB;
• subjects unable or unwilling to issue the informed consent;

Sponsors & Collaborators

• Laboratorio Farmaceutico Ct S.r.l.: lead

Related Publications (3)

• Skala K, Caputo F, Mirijello A, Vassallo G, Antonelli M, Ferrulli A, Walter H, Lesch O, Addolorato G. Sodium oxybate in the treatment of alcohol dependence: from the alcohol withdrawal syndrome to the alcohol relapse prevention. Expert Opin Pharmacother. 2014 Feb;15(2):245-57. doi: 10.1517/14656566.2014.863278. Epub 2013 Nov 28.

  PMID: 24283802 RESULT

• van den Brink W, Addolorato G, Aubin HJ, Benyamina A, Caputo F, Dematteis M, Gual A, Lesch OM, Mann K, Maremmani I, Nutt D, Paille F, Perney P, Rehm J, Reynaud M, Simon N, Soderpalm B, Sommer WH, Walter H, Spanagel R. Efficacy and safety of sodium oxybate in alcohol-dependent patients with a very high drinking risk level. Addict Biol. 2018 Jul;23(4):969-986. doi: 10.1111/adb.12645.

  PMID: 30043457 RESULT

• Guiraud J, Addolorato G, Antonelli M, Aubin HJ, de Bejczy A, Benyamina A, Cacciaglia R, Caputo F, Dematteis M, Ferrulli A, Goudriaan AE, Gual A, Lesch OM, Maremmani I, Mirijello A, Nutt DJ, Paille F, Perney P, Poulnais R, Raffaillac Q, Rehm J, Rolland B, Rotondo C, Scherrer B, Simon N, Skala K, Soderpalm B, Somaini L, Sommer WH, Spanagel R, Vassallo GA, Walter H, van den Brink W. Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients: An international, multicenter, randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2022 Oct;36(10):1136-1145. doi: 10.1177/02698811221104063. Epub 2022 Jul 7.

  PMID: 35796481 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Roberto Cacciaglia

  Laboratorio Farmaceutico C.T.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The control medication (placebo) was identically-looking and identically tasting as active.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled study with parallel group

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 1, 2020
• Study Start: July 23, 2001
• Primary Completion: March 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share