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

PHASE4RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-02-16

Primary completion: 2025-11-01

Study completion finish: 2026-11-01

Study type

TREATMENT

Phase

PHASE4

Trial ID

NCT05408247

Intervention or treatment

DRUG: N-acetyl cysteine

DRUG: Placebo

Conditions

• Alcohol Use Disorder (AUD)

Image related to Alcohol Use Disorder (AUD)

Condition: Alcohol Use Disorder (AUD)
DRUG: N-acetyl cysteine and other drugs
Sydney, New South Wales, Australia and more
Sponsor: University of Sydney

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Drug Health Services, Royal Prince Alfred Hospital

Research sites nearby

Select from list below to view details:

Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Cornwall Street Medical Centre (UQ Health Care)
Annerley, Queensland, Australia
Turning Point
Richmond, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: N-acetyl Cysteine Generic name: N-acetyl cysteine. Brand: ACC-600 (Acetylcysteine). Strength: 600mg per capsule. Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules/day Duration: 12 weeks + Standard of Care: Medical Management.	DRUG: N-acetyl cysteine 2400mg/day
PLACEBO_COMPARATOR: Placebo Matched placebo Generic name: dicalcium phosphate Strength: 600mg per capsule Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules/day Duration: 12 weeks. + Standard of Care: Medical Management.	DRUG: Placebo Matched placebo

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Heavy Drinking Days	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	24 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Changes in Liver Function	Liver Function will be assessed through blood sample at baseline. We will measurement levels of enzyme gamma-glutamyl transferase (GGT), aspartate transaminase (AST), and alanine transaminase (ALT).	24 weeks
Absence of any HDD	Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels	24 weeks

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder