Clinical trial NCT05408247: A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
Official title: A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Alcohol Use Disorder (AUD)
Keywords: N-acetyl Cysteine
NAC
Alcohol Dependence
N-acetylcysteine
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2022-06-07
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.

Detailed description: Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.

Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.

Eligibility criteria: Inclusion Criteria:

* Alcohol Use Disorder according to the DSM-V criteria
* A desire to reduce or stop drinking
* Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks/day for men; ≥4 for women) in the month prior to screening
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Stable housing
* Willingness to give written informed consent

Exclusion Criteria:

* Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary)
* Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months)
* Any substance dependence other than nicotine
* Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation
* Concurrent use of selenium, vitamin D or other anti-oxidants
* Any alcohol pharmacotherapy within the past month

Primary outcomes:
measure: Heavy Drinking Days
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in Liver Function
timeFrame: 24 weeks
measure: Absence of any HDD
timeFrame: 24 weeks
Other outcomes:
measure: Cost-Efficacy
timeFrame: 12 weeks
measure: Changes in Alcohol Craving
timeFrame: 24 weeks
measure: Mean alcohol consumption per drinking day
timeFrame: 24 weeks
measure: Change in dependence Severity
timeFrame: 24 weeks
measure: Changes in Anxiety
timeFrame: 24 weeks
measure: Changes in Depression
timeFrame: 24 weeks
measure: Changes in Stress
timeFrame: 24 weeks
measure: Sleep Disturbances
timeFrame: 24 weeks
measure: Lifetime Consequences related to Drinking
timeFrame: Baseline
measure: Recent Consequences related to Drinking
timeFrame: 12 weeks
measure: Changes in Consequences related to Drinking
timeFrame: 24 weeks
measure: Drinking Dairy
timeFrame: 12 weeks
measure: Nicotine Dependence
timeFrame: Baseline
measure: Changes in Suicidal Ideation
timeFrame: 24 weeks
measure: Changes in Information Gathering ability
timeFrame: 24 weeks
measure: Changes in Attentional Control
timeFrame: 24 weeks
measure: Changes in Monitoring of Feedback
timeFrame: 24 weeks
measure: Irritability
timeFrame: Baseline
measure: Changes in Physical Activity
timeFrame: 24 weeks
measure: Changes in Quality of Life
timeFrame: 24 weeks
measure: Changes in Quality of Life
timeFrame: 24 weeks
measure: Changes in ability to inhibit prepotent responses
timeFrame: 24 weeks
measure: Changes in processing speed
timeFrame: 24 weeks
measure: Changes in DSM-5 PTSD symptomology
timeFrame: 24 weeks
measure: Changes in use of Health Services
timeFrame: 24 weeks
measure: Hangover Diary
timeFrame: 12 weeks
measure: Using Redox Markers to predict treatment response
timeFrame: Baseline
measure: Changes in Redox Markers
timeFrame: 12 weeks
Locations:
city: Sydney
country: Australia
facility: Drug Health Services, Royal Prince Alfred Hospital
state: New South Wales
city: Annerley
country: Australia
facility: Cornwall Street Medical Centre (UQ Health Care)
state: Queensland
city: Richmond
country: Australia
facility: Turning Point
state: Victoria
Study officials:
References: