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DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

Quick Stats
Studies 458
Trials 82
Recruiting PHASE4 INTERVENTIONAL NCT05408247

A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.

Detailed Description

Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities. Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.

Interventions

Name: N-acetyl cysteine
Type: DRUG
Description: 2400mg/day
Name: Placebo
Type: DRUG
Description: Matched placebo

Primary Outcomes

Measure: Heavy Drinking Days
TimeFrame: 24 weeks
Description: Reduction in Heavy Drinking Days (HDD; defined as 4 or more drinks in a day for women and five or more drinks in a day for men). This will be measured by the Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels

Trial Information

NCT ID

NCT05408247

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

University of Sydney

Last Updated

December 15, 2025