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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| University of Sydney | OTHER |
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The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.
Study 1: Relapse prevention: This is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive oral NAC (2400 mg: 2x 600mg tablets twice per day) or matching placebo. Trial participants will receive either oral NAC ( dose stated above) or matching placebo for up to 4 weeks.
Study 2: Withdrawal: Trial participants will receive oral NAC (dose stated above) or matching placebo within the first 24 hours of their admission for up to 3 days.
Study 3: Participants from the relapse prevention substudy will also receive 30-minute non-invasive brain imaging session prior to and after completing the treatment regime in Study 1.
Both males and females will be recruited for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | NAC - Relapse Prevention (4 wks) |
|
| Arm 2 | Placebo Comparator | NAC - Relapse Prevention (4 wks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAC 2400mg/day | Drug | 2400mg/day 2 x 600mg b.d |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Study 1: Alcohol consumption | as measured by the number of heavy drinking days per week and number of drinks per drinking day | 4 weeks |
| Study 1: Alcohol consumption | as measured by the abstinence rate, time to relapse and time to lapse | 4 weeks |
| Study 2: Amount of Benzodiazepines administered | as measured by the number of benzodiazepines administered in the NAC vs placebo groups | 3 days |
| Study 2: Amount of Benzodiazepines administered | as measured by Alcohol Withdrawal Scale (AWS) score | 3 days |
| Study 2: Amount of Benzodiazepines administered | as measured by Visual Analogue Scale (VAS) score | 3 days |
| Study 2: Amount of Benzodiazepines administered | as measured by Alcohol Urge Questionaire (AUQ) Score | 3 days |
| Study 3: Markers of neural inflammation and responses to alcohol cue | as measured by differences in cortical levels of glutathione | 4 weeks |
| Study 3: Markers of neural inflammation and responses to alcohol cue | as measured by differences in cortical levels of N-acetylaspartate |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol craving | as measured by Penn Alcohol Craving Scale (PACS) score | 4 weeks |
| Mood | as measured by Depression Anxiety Stress Scale (DASS) score |
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Inclusion Criteria:
Exclusion Criteria:
The following exclusion criteria are only applicable to participants undergoing the brain imaging session:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Morley, PhD | Contact | +61295153636 | kirsten.morley@sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Paul S Haber, MBBS | Sydney Local Health District | Principal Investigator |
| Andrew Baille, PhD | Macquarie University | Principal Investigator |
| Kirsten Morley, PhD |
| 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 |
|---|---|---|---|
| 41128676 | Derived | Dunbar KY, Dali G, DeMayo MM, Logge W, Hurzeler T, Kelly C, Watt J, Squeglia LM, Kirkland AE, Haber PS, Morley KC. The Effect of N-Acetylcysteine (NAC) on Neurometabolites and Cognitive Function in Adults With Alcohol Use Disorder: A Preliminary Randomized Controlled Trial. Neuropsychopharmacol Rep. 2025 Dec;45(4):e70066. doi: 10.1002/npr2.70066. | |
| 39102049 |
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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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Study 1: NAC vs Placebo (PL) (4 weeks outpatient) Study 2: NAC vs PL (3 days inpatient) Study 2: NAC vs PL (neuromaging session before vs after treatment)
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| Drug |
4 matched placebo tablets/day |
|
| 4 weeks |
| Study 3: Markers of neural inflammation and responses to alcohol cue | as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation) | 4 weeks |
| 4 weeks |
| University of Sydney |
| Principal Investigator |
| Warren B Logge, PhD | Sydney Local Health District | Principal Investigator |
| Logge WB, Haber PS, Hurzeler TP, Towers EE, Morley KC. The effects of N-acetyl cysteine on intrinsic functional connectivity and neural alcohol cue reactivity in treatment-seeking individuals with alcohol use disorder: a preliminary study. Psychopharmacology (Berl). 2025 Jan;242(1):149-160. doi: 10.1007/s00213-024-06656-z. Epub 2024 Aug 5. |