NCT03018236

Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.

The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use disorders. Alcohol users will be split in two groups, one will receive the active N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress biomarkers will be evaluated.

Detailed description

N-acetylcysteine acts replenishing the human body glutathione storages. Glutathione is an important antioxidant agent, and also modulates the N-methyl-D-aspartate (NMDA) glutamatergic receptor. Glutamate has been associated with the neuroadaptation related to substance use disorders, and thus it is considered a potential target for pharmacological interventions regarding these disorders. N-acetylcysteine also interacts with the cystine-glutamate antiporter on astrocytes hence increasing glutamate release into the extracellular space. N-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. Glutamate levels normalization through N-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. In addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders. This study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into NAC vs Placebo and cocaine users divided into NAC vs Placebo.

Conditions

• Cocaine Addiction
• Alcohol Addiction

Interventions

Type	Name	Description
DRUG	Alcohol N-acetylcysteine	1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
DRUG	Alcohol Placebo	Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
DRUG	Cocaine N-acetylcysteine	1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
DRUG	Cocaine Placebo	Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-07-01
• Completion: 2018-12-01
• First posted: 2017-01-11
• Last updated: 2017-01-24

Locations

1 site across 1 country: Brazil