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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 11, 2017
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)		 Number of participants who attended all study appointments [ Time Frame: 8 weeks ]
Completers (i.e. subjects who attended all study appointments) vs non-completers
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)		 Adherence [ Time Frame: 8 weeks ]
Completers (i.e. subjects who attended all study appointments) vs non-completers
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Abstinence by urine [ Time Frame: 8 weeks ]
    Amount of positive urine tests for cocaine users
  • Abstinence by breathalyzer [ Time Frame: 8 weeks ]
    Amount of positive breathalyzer tests for alcohol users
  • Abstinence by self report [ Time Frame: 8 weeks ]
    Timeline Followback Method
  • 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.
  • Change in scores of CGI [ Time Frame: 8 weeks ]
    Differences in scores of the Clinical Global Impression (CGI)
  • Change in scores of FAST [ Time Frame: 8 weeks ]
    Differences in scores of the Functioning Assessment Short Test (FAST).
  • Depressive symptoms [ Time Frame: 8 weeks ]
    Differences in scores of the Beck Depression Inventory (BDI)
  • Anxiety symptoms [ Time Frame: 8 weeks ]
    Differences in scores of the Beck Anxiety Inventory (BAI)
  • BDNF [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)
  • GSSG [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Oxidized Glutathione (GSSG)
  • GSH [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Glutathione (GSH)
  • GPx [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Glutathione Peroxidase (GPx)
  • CAT [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Catalase (CAT)
  • TBARS [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)
  • SOD [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Superoxide Dismutase (SOD)
  • Carbonyl [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Carbonyl
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Abstinence by urine [ Time Frame: 8 weeks ]
    Amount of positive urine tests for cocaine users
  • Abstinence by breathalyzer [ Time Frame: 8 weeks ]
    Amount of positive breathalyzer tests for alcohol users
  • Abstinence by self report [ Time Frame: 8 weeks ]
    Timeline Followback Method
  • 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.
  • Global functioning 1 [ Time Frame: 8 weeks ]
    Differences in scores of the Clinical Global Impression (CGI)
  • Global functioning 2 [ Time Frame: 8 weeks ]
    Differences in scores of the Functioning Assessment Short Test (FAST).
  • Depressive symptoms [ Time Frame: 8 weeks ]
    Differences in scores of the Beck Depression Inventory (BDI)
  • Anxiety symptoms [ Time Frame: 8 weeks ]
    Differences in scores of the Beck Anxiety Inventory (BAI)
  • BDNF [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)
  • Oxidative stress 1 [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Oxidized Glutathione (GSSG)
  • Oxidative stress 2 [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Glutathione (GSH)
  • Oxidative stress 3 [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Glutathione Peroxidase (GPx)
  • Oxidative stress 4 [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Catalase (CAT)
  • Oxidative stress 5 [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)
  • Oxidative stress 6 [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Superoxide Dismutase (SOD)
  • Oxidative stress 7 [ Time Frame: 8 weeks ]
    Differences between groups regarding dosage of Carbonyl
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2017)		 Adverse events [ Time Frame: 8 weeks ]
Systematic Assessment for Treatment Emergent Events (SAFTEE) application
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
Official Title  ICMJE The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cocaine Addiction
  • Alcohol Addiction
Intervention  ICMJE
  • Drug: Alcohol N-acetylcysteine
    1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
    Other Name: NAC
  • Drug: Alcohol Placebo
    Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
  • Drug: Cocaine N-acetylcysteine
    1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
    Other Name: NAC
  • Drug: Cocaine Placebo
    Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
Study Arms  ICMJE
  • Experimental: Alcohol N-acetylcysteine
    600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
    Intervention: Drug: Alcohol N-acetylcysteine
  • Placebo Comparator: Alcohol Placebo
    A placebo capsule matching color and smell of the active medication
    Intervention: Drug: Alcohol Placebo
  • Experimental: Cocaine N-acetylcysteine
    600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
    Intervention: Drug: Cocaine N-acetylcysteine
  • Placebo Comparator: Cocaine Placebo
    A placebo capsule matching color and smell of the active medication
    Intervention: Drug: Cocaine Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03018236
Other Study ID Numbers  ICMJE 150488
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Secretaria Nacional de Políticas sobre Drogas (SENAD)
Investigators  ICMJE
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)
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP