NCT03879759

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: South West Sydney Local Health District · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	NAC 2400mg/day	2400mg/day 2 x 600mg b.d
DRUG	Placebo	4 matched placebo tablets/day

Timeline

• Start date: 2018-08-22
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2019-03-19
• Last updated: 2019-03-19

Locations

1 site across 1 country: Australia