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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03879759




Registration number
NCT03879759
Ethics application status
Date submitted
10/03/2019
Date registered
19/03/2019
Date last updated
19/03/2019

Titles & IDs
Public title
The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence
Scientific title
The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine for Alcohol Dependence: An Exploratory Pilot Study
Secondary ID [1] 0 0
X17-0343
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NAC 2400mg/day
Treatment: Drugs - Placebo

Experimental: Arm 1 - NAC - Relapse Prevention (4 wks)

Placebo Comparator: Arm 2 - NAC - Relapse Prevention (4 wks)


Treatment: Drugs: NAC 2400mg/day
2400mg/day 2 x 600mg b.d

Treatment: Drugs: Placebo
4 matched placebo tablets/day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Study 1: Alcohol consumption - as measured by the number of heavy drinking days per week and number of drinks per drinking day
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Study 1: Alcohol consumption - as measured by the abstinence rate, time to relapse and time to lapse
Timepoint [2] 0 0
4 weeks
Primary outcome [3] 0 0
Study 2: Amount of Benzodiazepines administered - as measured by the number of benzodiazepines administered in the NAC vs placebo groups
Timepoint [3] 0 0
3 days
Primary outcome [4] 0 0
Study 2: Amount of Benzodiazepines administered - as measured by Alcohol Withdrawal Scale (AWS) score
Timepoint [4] 0 0
3 days
Primary outcome [5] 0 0
Study 2: Amount of Benzodiazepines administered - as measured by Visual Analogue Scale (VAS) score
Timepoint [5] 0 0
3 days
Primary outcome [6] 0 0
Study 2: Amount of Benzodiazepines administered - as measured by Alcohol Urge Questionaire (AUQ) Score
Timepoint [6] 0 0
3 days
Primary outcome [7] 0 0
Study 3: Markers of neural inflammation and responses to alcohol cue - as measured by differences in cortical levels of glutathione
Timepoint [7] 0 0
4 weeks
Primary outcome [8] 0 0
Study 3: Markers of neural inflammation and responses to alcohol cue - as measured by differences in cortical levels of N-acetylaspartate
Timepoint [8] 0 0
4 weeks
Primary outcome [9] 0 0
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)
Timepoint [9] 0 0
4 weeks
Secondary outcome [1] 0 0
Alcohol craving - as measured by Penn Alcohol Craving Scale (PACS) score
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Mood - as measured by Depression Anxiety Stress Scale (DASS) score
Timepoint [2] 0 0
4 weeks

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Drug Health Services, Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03879759
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Haber, MBBS
Address 0 0
Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirsten Morley, PhD
Address 0 0
Country 0 0
Phone 0 0
+61295153636
Fax 0 0
Email 0 0
kirsten.morley@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03879759