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

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 4

Conditions: Cocaine Addiction; Alcohol Addiction

Treatments: Drug: Alcohol Placebo; Drug: Cocaine N-acetylcysteine; Drug: Cocaine Placebo; Drug: Alcohol N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT03018236

150488

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnostic of Alcohol or Cocaine Use Disorder
• Seven days of inpatient treatment in an addiction treatment specialized unit

Exclusion criteria

• Another Substance Use Disorder (exception: tobacco)
• Severe medical conditions (cardiac, renal or hepatic), that preclude subject participation
• History of asthma or convulsions medication use
• Recent use (<14 days) of any medication that could interfere with the study medication
• History of anaphylactic reactions with the study medication
• Suicide risk
• Inability to understand the informed consent form or to comply with the study requirements
• Any severe neuropsychiatric condition, not caused by the substance use, that requires specific medication treatments and could interfere with the study development, in the investigators opinion (for instance: dementia, schizophrenia or other psychoses, multiple sclerosis, severe depression, stroke, epilepsy, bipolar disorder)
• Failing to complete the screening procedures prior to the study first week

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

Alcohol N-acetylcysteine

Experimental group

Description:

600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks

Treatment:

Drug: Alcohol N-acetylcysteine

Alcohol Placebo

Placebo Comparator group

Description:

A placebo capsule matching color and smell of the active medication

Treatment:

Drug: Alcohol Placebo

Cocaine N-acetylcysteine

Experimental group

Description:

600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks

Treatment:

Drug: Cocaine N-acetylcysteine

Cocaine Placebo

Placebo Comparator group

Description:

A placebo capsule matching color and smell of the active medication

Treatment:

Drug: Cocaine Placebo