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| Name | Class |
|---|---|
| Monash University | OTHER |
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To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl cysteine | Drug | 2400mg/day |
|
|
| Measure | Description | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-Efficacy | Examine the cost-efficacy between NAC and placebo from both health sector and societal perspectives. Measured by Disability-Adjusted Life Years (DALYs) | 12 weeks |
| Changes in Alcohol Craving |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Morley, PhD | Contact | 61295153636 | Kirsten.morley@sydney.edu.au | |
| Paul Haber, MBBS | Contact | paul.haber@sydney.edu.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drug Health Services, Royal Prince Alfred Hospital | Recruiting | Sydney | New South Wales | 2050 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40921646 | Derived | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Double-blind design
| Placebo | Drug | Matched placebo |
|
Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels |
| 24 weeks |
As measured by the Alcohol Craving Experience Questionnaire (ACEQ). Higher scores indicate more severe craving.
| 24 weeks |
| Mean alcohol consumption per drinking day | Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels | 24 weeks |
| Change in dependence Severity | Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence. | 24 weeks |
| Changes in Anxiety | Measured by cumulative scores on the DASS-21 Anxiety Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more anxiety. | 24 weeks |
| Changes in Depression | Measured by cumulative scores on the DASS-21 Depression Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates greater depression. | 24 weeks |
| Changes in Stress | Measured by cumulative scores on the DASS-21 Stress Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more stress. | 24 weeks |
| Sleep Disturbances | As measured by the ISI (Insomnia Severity Index). This Index has a minimum score of 0 and a maximum score of 28. The higher the score indicates more severe insomnia. | 24 weeks |
| Lifetime Consequences related to Drinking | To examine the adverse consequences a participant has experienced in their lifetime due to alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. This is measured using the Drinker Inventory of Consequences Lifetime Edition (DrInC-2L). Higher scores indicate more consequences. | Baseline |
| Recent Consequences related to Drinking | To examine the adverse consequences a participant has experienced in the last 3 months due to alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. This is measured using the Drinker Inventory of Consequences Recent Edition (DrInC-2R). Higher scores indicate more consequences. | 12 weeks |
| Changes in Consequences related to Drinking | To examine the change in adverse consequences a participant has experienced across the trial due to alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. This is measured by comparing the Drinker Inventory of Consequences Recent Edition (DrInC-2R) and the Drinker Inventory of Consequences Lifetime Edition (DrInC-2L). Higher scores indicate more consequences. | 24 weeks |
| Drinking Dairy | Daily texts will be sent out to participants querying the amount of alcohol they have consumed. Participant responses to this will be recorded. This will be managed through SEMA software. | 12 weeks |
| Nicotine Dependence | Measured by the Fagerstrom Test for Nicotine Dependence (FTND). This test has a minimum score of 0 and a maximum score of 10. Higher scores indicate a more intense physical dependence on nicotine. | Baseline |
| Changes in Suicidal Ideation | As measured by the Suicidal Ideation Attributes Scale (SIDAS). This scale has a minimum score of 0 and a maximum score of 50. Higher scores indicate more severe suicidal thoughts. | 24 weeks |
| Changes in Information Gathering ability | As measured by the Caravan Spotter task of the Cognitive Impulsivity Suite (CIS). This measures information gathering through a perceptual decision making task whereby the target is initially ambiguous but progressively becomes clearer. | 24 weeks |
| Changes in Attentional Control | As measured by the Bounty Hunter task of the Cognitive Impulsivity Suite (CIS). This measures attentional control using a Go/No Go task. | 24 weeks |
| Changes in Monitoring of Feedback | As measured by the Prospectors Gamble task of the Cognitive Impulsivity Suite (CIS). This involves a probabilistic reverse learning task to measure monitoring of feedback. | 24 weeks |
| Irritability | As measured by the Brief Irritability Test (BITe). This test has a minimum score of 0 and a maximum score of 30. Higher scores indicate greater irritability. | Baseline |
| Changes in Physical Activity | To assess an individuals' health based on the previous 7 days of physical activity. This is measured by the International Physical Activity Questionnaire (IPAQ-Long). We are interested in whether across treatment, answers to this questionnaire will change. | 24 weeks |
| Changes in Quality of Life | To assess whether treatment can change quality of life as measured by the short form Health Survey (SF-36). This survey has 36 items that measure 8 domains of health, including: physical functioning, physical role limitations, bodily pain, general health perceptions, energy/vitality, social functioning, emotional role limitations and mental health. The scores are transformed to range from 0 (worst possible health) to 100 (best possible health). | 24 weeks |
| Changes in Quality of Life | As measured by the EQ-5D-5L. This instrument measures 5 different domains of life including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is assessed by one question. This instrument has a minimum score of 0 (worst possible health) and a maximum score of 1 (best possible health). | 24 weeks |
| Changes in ability to inhibit prepotent responses | As measured by the Stroop Colour Word Test. This test measures ability to inhibit prepotent responses and processing speed. This is assessed through the time it takes for an individual to appropriately select an incongruent response. For example, selecting "black" for the word "black" that is coloured in "green". Higher scores indicate worse performance. | 24 weeks |
| Changes in processing speed | As measured by the Trail Making Task (TMT). This test measures the ability to an individual to process visual stimuli, as measured in time. In the TMT Part A, individuals are instructed to draw a line between numbers, 1-2-3-4-5. Higher time indicates slower processing speed. In the TMT Part B individuals are instructed to switch between drawing lines between numbers and letters, for example 1-A-2-B-3-C. Higher time indicates worse processing speed and switching ability. | 24 weeks |
| Changes in DSM-5 PTSD symptomology | As measured by the PCL-5. This self-report questionnaire lists 20-items that assess DSM-5 PTSD criteria. A higher score indicates greater severity | 24 weeks |
| Changes in use of Health Services | As measured by the Brief Health Services Use Questionnaire. This questionnaire assesses Health Service Use across the last 3 months. | 24 weeks |
| Hangover Diary | Daily texts will be sent out to participants querying the hangover symptoms they are experiencing, if any. Participant responses to this will be recorded. This will be managed through SEMA software. | 12 weeks |
| Using Redox Markers to predict treatment response | We will use blood samples collected at baseline to measure redox markers (GPxBC, GSHBC). At the end of treatment we will see whether these markers are predictive of treatment response | Baseline |
| Changes in Redox Markers | We will use blood samples collected at baseline and wk 12 to measure changes in redox markers (GPxBC, GSHBC) | 12 weeks |
| Cornwall Street Medical Centre (UQ Health Care) | Not yet recruiting | Annerley | Queensland | 4103 | Australia |
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| Turning Point | Active, not recruiting | Richmond | Victoria | 3121 | Australia |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |