The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence

NCT ID: NCT03879759

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2020-11-30

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.

Detailed Description

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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

NAC - Relapse Prevention (4 wks)

Group Type: EXPERIMENTAL

NAC 2400mg/day

Intervention Type: DRUG

2400mg/day 2 x 600mg b.d

Arm 2

NAC - Relapse Prevention (4 wks)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4 matched placebo tablets/day

Interventions

NAC 2400mg/day

2400mg/day 2 x 600mg b.d

Intervention Type: DRUG

Placebo

4 matched placebo tablets/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol use disorder (this is an exclusion for the healthy control sample)
• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

South West Sydney Local Health District

OTHER

Sponsor Role: lead

Responsible Party

Professor Paul Haber

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul S Haber, MBBS

Role: PRINCIPAL_INVESTIGATOR

Sydney Local Health District

Andrew Baille, PhD

Role: PRINCIPAL_INVESTIGATOR

Macquarie University

Kirsten Morley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Warren B Logge, PhD

Role: PRINCIPAL_INVESTIGATOR

Sydney Local Health District

Locations

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Kirsten Morley, PhD

Role: CONTACT

kirsten.morley@sydney.edu.au

+61295153636

Facility Contacts

Kirsten M Morley, PhD

Role: primary

kirsten.morley@sydney.edu.au

+61295153636

Central Intake Line

Role: backup

sydneyalcoholtreatmentgroup@gmail.com

0459877108

References

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.

Reference Type: DERIVED

PMID: 41128676 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39102049 (View on PubMed)

Other Identifiers

X17-0343

Identifier Type: -

Identifier Source: org_study_id