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

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ClinicalTrials.gov Identifier: NCT03879759
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
University of Sydney
Information provided by (Responsible Party):
Professor Paul Haber, South West Sydney Local Health District

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: NAC 2400mg/day Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine for Alcohol Dependence: An Exploratory Pilot Study
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
NAC - Relapse Prevention (4 wks)
Drug: NAC 2400mg/day
2400mg/day 2 x 600mg b.d

Placebo Comparator: Arm 2
NAC - Relapse Prevention (4 wks)
Drug: Placebo
4 matched placebo tablets/day




Primary Outcome Measures :
  1. Study 1: Alcohol consumption [ Time Frame: 4 weeks ]
    as measured by the number of heavy drinking days per week and number of drinks per drinking day

  2. Study 1: Alcohol consumption [ Time Frame: 4 weeks ]
    as measured by the abstinence rate, time to relapse and time to lapse

  3. Study 2: Amount of Benzodiazepines administered [ Time Frame: 3 days ]
    as measured by the number of benzodiazepines administered in the NAC vs placebo groups

  4. Study 2: Amount of Benzodiazepines administered [ Time Frame: 3 days ]
    as measured by Alcohol Withdrawal Scale (AWS) score

  5. Study 2: Amount of Benzodiazepines administered [ Time Frame: 3 days ]
    as measured by Visual Analogue Scale (VAS) score

  6. Study 2: Amount of Benzodiazepines administered [ Time Frame: 3 days ]
    as measured by Alcohol Urge Questionaire (AUQ) Score

  7. Study 3: Markers of neural inflammation and responses to alcohol cue [ Time Frame: 4 weeks ]
    as measured by differences in cortical levels of glutathione

  8. Study 3: Markers of neural inflammation and responses to alcohol cue [ Time Frame: 4 weeks ]
    as measured by differences in cortical levels of N-acetylaspartate

  9. Study 3: Markers of neural inflammation and responses to alcohol cue [ Time Frame: 4 weeks ]
    as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation)


Secondary Outcome Measures :
  1. Alcohol craving [ Time Frame: 4 weeks ]
    as measured by Penn Alcohol Craving Scale (PACS) score

  2. Mood [ Time Frame: 4 weeks ]
    as measured by Depression Anxiety Stress Scale (DASS) score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879759


Contacts
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Contact: Kirsten Morley, PhD +61295153636 kirsten.morley@sydney.edu.au

Locations
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Australia, New South Wales
Drug Health Services, Royal Prince Alfred Hospital Recruiting
Sydney, New South Wales, Australia, 2050
Contact: Kirsten M Morley, PhD    +61295153636    kirsten.morley@sydney.edu.au   
Contact: Central Intake Line    0459877108    sydneyalcoholtreatmentgroup@gmail.com   
Principal Investigator: Kirsten Morley, PhD         
Sponsors and Collaborators
South West Sydney Local Health District
National Health and Medical Research Council, Australia
University of Sydney
Investigators
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Principal Investigator: Paul S Haber, MBBS Sydney Local Health District
Principal Investigator: Andrew Baille, PhD Macquarie University
Principal Investigator: Kirsten Morley, PhD University of Sydney
Principal Investigator: Warren B Logge, PhD Sydney Local Health District

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Responsible Party: Professor Paul Haber, Clinical Director, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT03879759     History of Changes
Other Study ID Numbers: X17-0343
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes