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

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ClinicalTrials.gov Identifier: NCT03018236
Recruitment Status : Unknown
Verified January 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : January 11, 2017
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Secretaria Nacional de Políticas sobre Drogas (SENAD)
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Alcohol Addiction Drug: Alcohol N-acetylcysteine Drug: Alcohol Placebo Drug: Cocaine N-acetylcysteine Drug: Cocaine Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
Study Start Date : January 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who attended all study appointments [ Time Frame: 8 weeks ]
    Completers (i.e. subjects who attended all study appointments) vs non-completers


Secondary Outcome Measures :
  1. Abstinence by urine [ Time Frame: 8 weeks ]
    Amount of positive urine tests for cocaine users

  2. Abstinence by breathalyzer [ Time Frame: 8 weeks ]
    Amount of positive breathalyzer tests for alcohol users

  3. Abstinence by self report [ Time Frame: 8 weeks ]
    Timeline Followback Method

  4. 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.

  5. Change in scores of CGI [ Time Frame: 8 weeks ]
    Differences in scores of the Clinical Global Impression (CGI)

  6. Change in scores of FAST [ Time Frame: 8 weeks ]
    Differences in scores of the Functioning Assessment Short Test (FAST).

  7. Depressive symptoms [ Time Frame: 8 weeks ]
    Differences in scores of the Beck Depression Inventory (BDI)

  8. Anxiety symptoms [ Time Frame: 8 weeks ]
    Differences in scores of the Beck Anxiety Inventory (BAI)

  9. BDNF [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)

  10. GSSG [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Oxidized Glutathione (GSSG)

  11. GSH [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Glutathione (GSH)

  12. GPx [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Glutathione Peroxidase (GPx)

  13. CAT [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Catalase (CAT)

  14. TBARS [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)

  15. SOD [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Superoxide Dismutase (SOD)

  16. Carbonyl [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Carbonyl


Other Outcome Measures:
  1. Adverse events [ Time Frame: 8 weeks ]
    Systematic Assessment for Treatment Emergent Events (SAFTEE) application


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018236


Contacts
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Contact: Lisia von Diemen, PhD +55 51 3359 6471 lisiavd@gmail.com
Contact: Thiago C Hartmann, MsC +55 51 3359 6476 hartmann321@yahoo.com.br

Locations
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Brazil
Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim Recruiting
Porto Alegre, RS, Brazil, 90420-020
Contact: Thiago C Hartmann, MsC    +55 51 3359 6476    hartmann321@yahoo.com.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Secretaria Nacional de Políticas sobre Drogas (SENAD)
Investigators
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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)
More Information
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Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03018236    
Other Study ID Numbers: 150488
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
cocaine
alcohol
substance use disorders
 addiction
N-acetylcysteine
randomized controlled trial
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Alcoholism
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders
Ethanol
Acetylcysteine
Cocaine
N-monoacetylcystine
Anti-Infective Agents, Local
Anti-Infective Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Antiviral Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents