Clinical trial NCT03879759: The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence
Official title: The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine for Alcohol Dependence: An Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alcohol Dependence
Lead sponsor: South West Sydney Local Health District
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: University of Sydney
First posted: 2019-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Study 1: Alcohol consumption
timeFrame: 4 weeks
measure: Study 1: Alcohol consumption
timeFrame: 4 weeks
measure: Study 2: Amount of Benzodiazepines administered
timeFrame: 3 days
measure: Study 2: Amount of Benzodiazepines administered
timeFrame: 3 days
measure: Study 2: Amount of Benzodiazepines administered
timeFrame: 3 days
measure: Study 2: Amount of Benzodiazepines administered
timeFrame: 3 days
measure: Study 3: Markers of neural inflammation and responses to alcohol cue
timeFrame: 4 weeks
measure: Study 3: Markers of neural inflammation and responses to alcohol cue
timeFrame: 4 weeks
measure: Study 3: Markers of neural inflammation and responses to alcohol cue
timeFrame: 4 weeks
Secondary outcomes:
measure: Alcohol craving
timeFrame: 4 weeks
measure: Mood
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Drug Health Services, Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: Sydney Local Health District
name: Paul S Haber, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Macquarie University
name: Andrew Baille, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Kirsten Morley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sydney Local Health District
name: Warren B Logge, PhD
role: PRINCIPAL_INVESTIGATOR
References: