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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03879759
• Other study ID #: X17-0343
• Status: Recruiting
• Phase: Phase 2
• Start date: August 22, 2018
• Est. completion date: November 2020

Study information

• Verified date: March 2019
• Source: South West Sydney Local Health District
• Contact: Kirsten Morley, PhD
• Phone: +61295153636
• Email: kirsten.morley[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• NAC 2400mg/day
2400mg/day 2 x 600mg b.d
• Placebo
4 matched placebo tablets/day

Locations

Country	Name	City	State
Australia	Drug Health Services, Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
South West Sydney Local Health District	National Health and Medical Research Council, Australia, University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

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