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

January 20, 2017 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90420-020
        • Recruiting
        • Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol N-acetylcysteine
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Drug: Alcohol N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
Other Names:
  • NAC
Placebo Comparator: Alcohol Placebo
A placebo capsule matching color and smell of the active medication
Drug: Alcohol Placebo
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
Experimental: Cocaine N-acetylcysteine
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Drug: Cocaine N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
Other Names:
  • NAC
Placebo Comparator: Cocaine Placebo
A placebo capsule matching color and smell of the active medication
Drug: Cocaine Placebo
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who attended all study appointments
Time Frame: 8 weeks
Completers (i.e. subjects who attended all study appointments) vs non-completers
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence by urine
Time Frame: 8 weeks
Amount of positive urine tests for cocaine users
8 weeks
Abstinence by breathalyzer
Time Frame: 8 weeks
Amount of positive breathalyzer tests for alcohol users
8 weeks
Abstinence by self report
Time Frame: 8 weeks
Timeline Followback Method
8 weeks
Days of inpatient treatment
Time Frame: Up to 4 weeks
The difference (if any) between placebo and intervention groups in the amount of inpatient treatment days.
Up to 4 weeks
Change in scores of CGI
Time Frame: 8 weeks
Differences in scores of the Clinical Global Impression (CGI)
8 weeks
Change in scores of FAST
Time Frame: 8 weeks
Differences in scores of the Functioning Assessment Short Test (FAST).
8 weeks
Depressive symptoms
Time Frame: 8 weeks
Differences in scores of the Beck Depression Inventory (BDI)
8 weeks
Anxiety symptoms
Time Frame: 8 weeks
Differences in scores of the Beck Anxiety Inventory (BAI)
8 weeks
BDNF
Time Frame: 8 weeks
Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)
8 weeks
GSSG
Time Frame: 8 weeks
Differences between groups regarding dosage of Oxidized Glutathione (GSSG)
8 weeks
GSH
Time Frame: 8 weeks
Differences between groups regarding dosage of Glutathione (GSH)
8 weeks
GPx
Time Frame: 8 weeks
Differences between groups regarding dosage of Glutathione Peroxidase (GPx)
8 weeks
CAT
Time Frame: 8 weeks
Differences between groups regarding dosage of Catalase (CAT)
8 weeks
TBARS
Time Frame: 8 weeks
Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)
8 weeks
SOD
Time Frame: 8 weeks
Differences between groups regarding dosage of Superoxide Dismutase (SOD)
8 weeks
Carbonyl
Time Frame: 8 weeks
Differences between groups regarding dosage of Carbonyl
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 8 weeks
Systematic Assessment for Treatment Emergent Events (SAFTEE) application
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Secretaria Nacional de Políticas sobre Drogas (SENAD)

Investigators

  • Study Chair: Lisia von Diemen, PhD, Federal University of Rio Grande do Sul (UFRGS)
  • Principal Investigator: Flavio Pechansky, PhD, Federal University of Rio Grande do Sul (UFRGS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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