Ireland
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Recruiting Phase 4

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

NCT05408247 · tracked via the Priya Life Science Australia tracker
Phase
Phase 4
Started
2023-02-16
Last updated
2023-03-16

Condition(s) studied

Alcohol Use Disorder (AUD)

Investigational drug(s) / intervention(s)

N-acetyl cysteine →Placebo

N-acetyl cysteine: 2400mg/day

Placebo: Matched placebo

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Alcohol Use Disorder according to the DSM-V criteria * A desire to reduce or stop drinking * Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks/day for men; ≥4 for women) in the month prior to screening * Adequate cognition and English language skills to give valid consent and complete research interviews * Stable housing * Willingness to give written informed consent Exclusion Criteria: * Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary) * Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months) * Any substance dependence other than nicotine * Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation * Concurrent use of selenium, vitamin D or other anti-oxidants * Any alcohol pharmacotherapy within the past month

Primary outcome measure(s)

  • Heavy Drinking Days — 24 weeks
    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 sites (3)

FacilityCityRegionStatus
Drug Health Services, Royal Prince Alfred Hospital Sydney New South Wales Recruiting
Cornwall Street Medical Centre (UQ Health Care) Annerley Queensland Not Yet Recruiting
Turning Point Richmond Victoria Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05408247 on ClinicalTrials.gov ↗ ← All trials in Australia