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

Primary Purpose

Alcohol Dependence

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
NAC 2400mg/day
Placebo
Sponsored by
South West Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Drug Health Services, Royal Prince Alfred HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

NAC - Relapse Prevention (4 wks)

NAC - Relapse Prevention (4 wks)

Outcomes

Primary Outcome Measures

Study 1: Alcohol consumption
as measured by the number of heavy drinking days per week and number of drinks per drinking day
Study 1: Alcohol consumption
as measured by the abstinence rate, time to relapse and time to lapse
Study 2: Amount of Benzodiazepines administered
as measured by the number of benzodiazepines administered in the NAC vs placebo groups
Study 2: Amount of Benzodiazepines administered
as measured by Alcohol Withdrawal Scale (AWS) score
Study 2: Amount of Benzodiazepines administered
as measured by Visual Analogue Scale (VAS) score
Study 2: Amount of Benzodiazepines administered
as measured by Alcohol Urge Questionaire (AUQ) Score
Study 3: Markers of neural inflammation and responses to alcohol cue
as measured by differences in cortical levels of glutathione
Study 3: Markers of neural inflammation and responses to alcohol cue
as measured by differences in cortical levels of N-acetylaspartate
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)

Secondary Outcome Measures

Alcohol craving
as measured by Penn Alcohol Craving Scale (PACS) score
Mood
as measured by Depression Anxiety Stress Scale (DASS) score

Full Information

First Posted
March 10, 2019
Last Updated
March 14, 2019
Sponsor
South West Sydney Local Health District
Collaborators
National Health and Medical Research Council, Australia, University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT03879759
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South West Sydney Local Health District
Collaborators
National Health and Medical Research Council, Australia, University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
NAC - Relapse Prevention (4 wks)
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
NAC - Relapse Prevention (4 wks)
Intervention Type
Drug
Intervention Name(s)
NAC 2400mg/day
Intervention Description
2400mg/day 2 x 600mg b.d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 matched placebo tablets/day
Primary Outcome Measure Information:
Title
Study 1: Alcohol consumption
Description
as measured by the number of heavy drinking days per week and number of drinks per drinking day
Time Frame
4 weeks
Title
Study 1: Alcohol consumption
Description
as measured by the abstinence rate, time to relapse and time to lapse
Time Frame
4 weeks
Title
Study 2: Amount of Benzodiazepines administered
Description
as measured by the number of benzodiazepines administered in the NAC vs placebo groups
Time Frame
3 days
Title
Study 2: Amount of Benzodiazepines administered
Description
as measured by Alcohol Withdrawal Scale (AWS) score
Time Frame
3 days
Title
Study 2: Amount of Benzodiazepines administered
Description
as measured by Visual Analogue Scale (VAS) score
Time Frame
3 days
Title
Study 2: Amount of Benzodiazepines administered
Description
as measured by Alcohol Urge Questionaire (AUQ) Score
Time Frame
3 days
Title
Study 3: Markers of neural inflammation and responses to alcohol cue
Description
as measured by differences in cortical levels of glutathione
Time Frame
4 weeks
Title
Study 3: Markers of neural inflammation and responses to alcohol cue
Description
as measured by differences in cortical levels of N-acetylaspartate
Time Frame
4 weeks
Title
Study 3: Markers of neural inflammation and responses to alcohol cue
Description
as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Alcohol craving
Description
as measured by Penn Alcohol Craving Scale (PACS) score
Time Frame
4 weeks
Title
Mood
Description
as measured by Depression Anxiety Stress Scale (DASS) score
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten Morley, PhD
Phone
+61295153636
Email
kirsten.morley@sydney.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S Haber, MBBS
Organizational Affiliation
Sydney Local Health District
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Baille, PhD
Organizational Affiliation
Macquarie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirsten Morley, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Warren B Logge, PhD
Organizational Affiliation
Sydney Local Health District
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drug Health Services, Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten M Morley, PhD
Phone
+61295153636
Email
kirsten.morley@sydney.edu.au
First Name & Middle Initial & Last Name & Degree
Central Intake Line
Phone
0459877108
Email
sydneyalcoholtreatmentgroup@gmail.com
First Name & Middle Initial & Last Name & Degree
Kirsten Morley, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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