Alcohol Use Disorder (AUD)Phase 4NAC-AUDNCT05408247
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
A Phase 4 study testing N-acetyl cysteine in people with Alcohol Use Disorder (AUD), run by University of Sydney at 3 sites in Australia.
Trial summary
To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 3 sitesAustralia
- Study dates
- 16 Feb 2023to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Haber, MBBS contact
Australia3 sites, 2 recruiting
- Not yet recruiting
Cornwall Street Medical Centre (UQ Health Care)
Annerley, Queensland, 4103
Paul Clark, MBBS, paul.j.clark@uq.edu.au
Paul Clark, MBBS
- Active, not recruiting
Turning Point
Richmond, Victoria, 3121
- Recruiting
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Kirsten Morley, Kirsten.morley@sydney.edu.au
Paul Haber
About this study
To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.
Read the 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- N-acetyl cysteine, Placebo
- Keywords
- N-acetyl Cysteine, NAC, Alcohol Dependence, N-acetylcysteine
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called NAC
2400mg/day
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl Cysteine | Experimental | 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. Receives: Drug: N-acetyl cysteine |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (2)
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).
Measured: 24 weeks
Absence of any HDD
Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start16 Feb 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408247
- Sponsor's protocol ID
- X21-0342
- Acronym
- NAC-AUD
- Status last verified
- Mar 2023
- First submitted
- 2 Jun 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morley K, Arunogiri S, Connor JP, Clark PJ, Chatterton ML, Baillie A, Slade T, Berk M, Lubman D, Haber PS. N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study). BMJ Open. 2025 Sep 8;15(9):e091631. doi: 10.1136/bmjopen-2024-091631.
PubMed 40921646
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05408247
- Acronym / sponsor ID
- NAC-AUD / X21-0342
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- N-acetyl Cysteine, NAC, Alcohol Dependence, N-acetylcysteine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl Cysteine | Experimental | Drug: N-acetyl cysteineGeneric 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. |
| Placebo | Placebo comparator | Drug: PlaceboMatched 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineAlso: NAC2400mg/day | Drug | N-acetyl Cysteine |
| PlaceboMatched placebo | Drug | Placebo |
Primary outcome
Heavy Drinking Days
Time frame: 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
2 secondary outcomes
Changes in Liver Function
Time frame: 24 weeks
Absence of any HDD
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 40921646Morley K, Arunogiri S, Connor JP, Clark PJ, Chatterton ML, Baillie A, Slade T, Berk M, Lubman D, Haber PS. N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study). BMJ Open. 2025 Sep 8;15(9):e091631. doi: 10.1136/bmjopen-2024-091631.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Haber, MBBS contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetyl cysteine in people with Alcohol Use Disorder (AUD), run by University of Sydney at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Morley, PhD (61295153636, Kirsten.morley@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy Drinking Days (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05408247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.