A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
NCT05408247, Phase 4, Recruiting, University of Sydney
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder | ClinicalTrials.gov |
| NCT number | NCT05408247 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 280 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Sydney | ClinicalTrials.gov |
| Conditions | Alcohol Use Disorder (AUD) | ClinicalTrials.gov |
| Interventions | N-acetyl cysteine, Placebo | ClinicalTrials.gov |
| First posted | 2022-06-07 | ClinicalTrials.gov |
| Last updated | 2023-03-16 | ClinicalTrials.gov |
Registered outcomes 31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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 | ClinicalTrials.gov |
| Secondary | Changes in Liver Function | 24 weeks | 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). | ClinicalTrials.gov |
| Secondary | Absence of any HDD | 24 weeks | Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels | ClinicalTrials.gov |
| Other | Cost-Efficacy | 12 weeks | Examine the cost-efficacy between NAC and placebo from both health sector and societal perspectives. Measured by Disability-Adjusted Life Years (DALYs) | ClinicalTrials.gov |
| Other | Changes in Alcohol Craving | 24 weeks | As measured by the Alcohol Craving Experience Questionnaire (ACEQ). Higher scores indicate more severe craving. | ClinicalTrials.gov |
| Other | Mean alcohol consumption per drinking day | 24 weeks | Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels | ClinicalTrials.gov |
| Other | Change in dependence Severity | 24 weeks | Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence. | ClinicalTrials.gov |
| Other | Changes in Anxiety | 24 weeks | 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. | ClinicalTrials.gov |
| Other | Changes in Depression | 24 weeks | 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. | ClinicalTrials.gov |
| Other | Changes in Stress | 24 weeks | 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. | ClinicalTrials.gov |
| Other | Sleep Disturbances | 24 weeks | 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. | ClinicalTrials.gov |
| Other | Lifetime Consequences related to Drinking | Baseline | 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. | ClinicalTrials.gov |
| Other | Recent Consequences related to Drinking | 12 weeks | 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. | ClinicalTrials.gov |
| Other | Changes in Consequences related to Drinking | 24 weeks | 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. | ClinicalTrials.gov |
| Other | Drinking Dairy | 12 weeks | 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. | ClinicalTrials.gov |
| Other | Nicotine Dependence | Baseline | 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. | ClinicalTrials.gov |
| Other | Changes in Suicidal Ideation | 24 weeks | 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. | ClinicalTrials.gov |
| Other | Changes in Information Gathering ability | 24 weeks | 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. | ClinicalTrials.gov |
| Other | Changes in Attentional Control | 24 weeks | As measured by the Bounty Hunter task of the Cognitive Impulsivity Suite (CIS). This measures attentional control using a Go/No Go task. | ClinicalTrials.gov |
| Other | Changes in Monitoring of Feedback | 24 weeks | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40921646 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Trail Making Test B | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)