The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence
1 other identifier
interventional
40
1 country
1
Brief Summary
The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2018
CompletedFirst Submitted
Initial submission to the registry
March 10, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMarch 19, 2019
March 1, 2019
2.2 years
March 10, 2019
March 14, 2019
Conditions
Outcome Measures
Primary Outcomes (9)
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
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
Secondary Outcomes (2)
Alcohol craving
4 weeks
Mood
4 weeks
Study Arms (2)
Arm 1
EXPERIMENTALNAC - Relapse Prevention (4 wks)
Arm 2
PLACEBO COMPARATORNAC - Relapse Prevention (4 wks)
Interventions
Eligibility Criteria
You may qualify if:
- Able to understand and sign written informed consent
- Must have a stable residence and be able to identify an individual who could locate subject if needed
- Admitted for medical detoxification from alcohol (withdrawal study only)
- Blood alcohol concentration of 0.00 (if completing brain imaging session)
- Express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only)
You may not qualify if:
- Clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern.
- Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control
- Women who are breastfeeding
- Dependence on any substance other than nicotine
- Court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only)
- Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only)
- Dependence on any substance other than nicotine
- Extreme obesity
- Pregnant or have any reason to believe they are pregnant;
- Previous brain surgery;
- Ever employed as a machinist, a welder or a metal worker;
- Epilepsy
- Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Related Publications (2)
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.
PMID: 41128676DERIVEDLogge 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.
PMID: 39102049DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul S Haber, MBBS
Sydney Local Health District
- PRINCIPAL INVESTIGATOR
Andrew Baille, PhD
Macquarie University
- PRINCIPAL INVESTIGATOR
Kirsten Morley, PhD
University of Sydney
- PRINCIPAL INVESTIGATOR
Warren B Logge, PhD
Sydney Local Health District
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Director
Study Record Dates
First Submitted
March 10, 2019
First Posted
March 19, 2019
Study Start
August 22, 2018
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
March 19, 2019
Record last verified: 2019-03