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Alcohol DependencePhase 2NCT03879759

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

A Phase 2 study testing NAC 2400mg/day in people with Alcohol Dependence, run by South West Sydney Local Health District at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Dependence
What is being tested?
NAC 2400mg/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteAustralia
Study dates
22 Aug 2018to Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 14Show fewer
  • Dependence on any substance other than nicotine
  • The following exclusion criteria are only applicable to participants undergoing the brain imaging session:
  • 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.

Trial locations and contacts

1 site in 1 country.

Kirsten Morley, PhD contact

+61295153636

kirsten.morley@sydney.edu.au

Australia1 site, 1 recruiting

  • Drug Health Services, Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

    Kirsten M Morley, PhD, +61295153636, kirsten.morley@sydney.edu.au

    Central Intake Line, 0459877108, sydneyalcoholtreatmentgroup@gmail.com

    Recruiting

Other trials in Australia

About this study

Official title: The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine for Alcohol Dependence: An Exploratory Pilot Study

The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.

Read the 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.

Being tested
NAC 2400mg/day, Placebo
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAC 2400mg/dayDrug

    2400mg/day 2 x 600mg b.d

  • PlaceboDrug

    4 matched placebo tablets/day

Study groups in NCT03879759
Study groupRoleWhat they receive
Arm 1ExperimentalNAC - Relapse Prevention (4 wks)
Receives: Drug: NAC 2400mg/day
Arm 2Placebo comparatorNAC - Relapse Prevention (4 wks)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study 1: Alcohol consumption

    as measured by the number of heavy drinking days per week and number of drinks per drinking day

    Measured: 4 weeks

  2. Study 1: Alcohol consumption

    as measured by the abstinence rate, time to relapse and time to lapse

    Measured: 4 weeks

  3. Study 2: Amount of Benzodiazepines administered

    as measured by the number of benzodiazepines administered in the NAC vs placebo groups

    Measured: 3 days

  4. Study 2: Amount of Benzodiazepines administered

    as measured by Alcohol Withdrawal Scale (AWS) score

    Measured: 3 days

  5. Study 2: Amount of Benzodiazepines administered

    as measured by Visual Analogue Scale (VAS) score

    Measured: 3 days

  6. Study 2: Amount of Benzodiazepines administered

    as measured by Alcohol Urge Questionaire (AUQ) Score

    Measured: 3 days

  7. Study 3: Markers of neural inflammation and responses to alcohol cue

    as measured by differences in cortical levels of glutathione

    Measured: 4 weeks

  8. Study 3: Markers of neural inflammation and responses to alcohol cue

    as measured by differences in cortical levels of N-acetylaspartate

    Measured: 4 weeks

  9. 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)

    Measured: 4 weeks

Secondary outcomes (2)

  1. Alcohol craving

    as measured by Penn Alcohol Craving Scale (PACS) score

    Measured: 4 weeks

  2. Mood

    as measured by Depression Anxiety Stress Scale (DASS) score

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start22 Aug 2018
  3. Primary completionNov 2020 (estimated)
  4. Study completionNov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879759
Sponsor's protocol ID
X17-0343
Status last verified
Mar 2019
First submitted
10 Mar 2019
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41128676

  • 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.

    PubMed 39102049

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NAC 2400mg/day in people with Alcohol Dependence, run by South West Sydney Local Health District at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kirsten Morley, PhD (+61295153636, kirsten.morley@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study 1: Alcohol consumption (time frame: 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879759, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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