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

Last updated: March 14, 2019
Sponsor: South West Sydney Local Health District
Overall Status: Active - Recruiting

Phase

2

Condition

Substance Abuse

Alcohol Dependence

Addictions

Treatment

N/A

Clinical Study ID

NCT03879759
X17-0343
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria forcurrent 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 locatesubject 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

Exclusion Criteria:

  • Clinically significant comorbidities or medical disease that might interfere with theevaluation of the study medication or present a safety concern.

  • Pregnant women and women of childbearing potential who do not practice a medicallyacceptable form of birth control

  • Women who are breastfeeding

  • Dependence on any substance other than nicotine

  • Court-mandated participation in alcohol treatment or pending incarceration (relapseprevention study only)

  • Treatment/ingestion during the previous week of benzodiazepines or othersedative-hypnotic medications or history of recent chronic treatment withsedative-hypnotic medications (withdrawal study only)

  • Dependence on any substance other than nicotine The following exclusion criteria are only applicable to participants undergoing the brainimaging 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; hearingaid or a prosthetic device.

Study Design

Total Participants: 40
Study Start date:
August 22, 2018
Estimated Completion Date:
November 30, 2020

Study 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.

Connect with a study center

  • Drug Health Services, Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

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