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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lisia von Diemen, PhD
  • Phone Number: +55 51 3359 6471
  • Email: lisiavd@gmail.com

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Secretaria Nacional de Políticas sobre Drogas (SENAD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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