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

NCT03018236 | Unknown Phase 4

• 1 other identifier: 150488
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Addiction; Alcohol Addiction

Keywords

cocaine; alcohol; substance use disorders; addiction; N-acetylcysteine; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Number of participants who attended all study appointments

  Completers (i.e. subjects who attended all study appointments) vs non-completers

  8 weeks

Secondary Outcomes (16)

• Abstinence by urine

  8 weeks

• Abstinence by breathalyzer

  8 weeks

• Abstinence by self report

  8 weeks

• Days of inpatient treatment

  Up to 4 weeks

• Change in scores of CGI

  8 weeks

Other Outcomes (1)

• Adverse events

  8 weeks

Study Arms (4)

Alcohol N-acetylcysteine

EXPERIMENTAL

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

Drug: Alcohol N-acetylcysteine

Alcohol Placebo

PLACEBO COMPARATOR

A placebo capsule matching color and smell of the active medication

Drug: Alcohol Placebo

Cocaine N-acetylcysteine

EXPERIMENTAL

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

Drug: Cocaine N-acetylcysteine

Cocaine Placebo

PLACEBO COMPARATOR

A placebo capsule matching color and smell of the active medication

Drug: Cocaine Placebo

Interventions

Alcohol N-acetylcysteine DRUG

1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder

Also known as: NAC

Alcohol N-acetylcysteine

Alcohol Placebo DRUG

Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder

Alcohol Placebo

Cocaine N-acetylcysteine DRUG

1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder

Also known as: NAC

Cocaine N-acetylcysteine

Cocaine Placebo DRUG

Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder

Cocaine Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Secretaria Nacional de Políticas sobre Drogas (SENAD): collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim

Porto Alegre, Rio Grande do Sul, 90420-020, Brazil

RECRUITING

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MeSH Terms

Conditions

Cocaine-Related Disorders; Alcoholism; Substance-Related Disorders; Behavior, Addictive

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Lisia von Diemen, PhD

  Federal University of Rio Grande do Sul (UFRGS)

  STUDY CHAIR

• Flavio Pechansky, PhD

  Federal University of Rio Grande do Sul (UFRGS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisia von Diemen, PhD

CONTACT

+55 51 3359 6471; lisiavd@gmail.com

Thiago C Hartmann, MsC

CONTACT

+55 51 3359 6476; hartmann321@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

BR (1)