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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborator: Secretaria Nacional de Políticas sobre Drogas (SENAD)
• Treatments: Acetylcysteine; Cocaine; Ethanol; N-monoacetylcystine

Criteria

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