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

Cocaine Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018236
• Other study ID #: 150488
• Status: Recruiting
• Phase: Phase 4
• First received: January 10, 2017
• Last updated: January 20, 2017
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Lisia von Diemen, PhD
• Phone: +55 51 3359 6471
• Email: lisiavd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Addiction
• Alcoholism
• Behavior, Addictive
• Cocaine Addiction
• Cocaine-Related Disorders

Intervention

Drug:
• Alcohol N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
• Alcohol Placebo
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
• Cocaine N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
• Cocaine Placebo
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Secretaria Nacional de Políticas sobre Drogas (SENAD)

Country where clinical trial is conducted

Brazil, 

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* Note: There are 71 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Systematic Assessment for Treatment Emergent Events (SAFTEE) application	8 weeks
Primary	Number of participants who attended all study appointments	Completers (i.e. subjects who attended all study appointments) vs non-completers	8 weeks
Secondary	Abstinence by urine	Amount of positive urine tests for cocaine users	8 weeks
Secondary	Abstinence by breathalyzer	Amount of positive breathalyzer tests for alcohol users	8 weeks
Secondary	Abstinence by self report	Timeline Followback Method	8 weeks
Secondary	Days of inpatient treatment	The difference (if any) between placebo and intervention groups in the amount of inpatient treatment days.	Up to 4 weeks
Secondary	Change in scores of CGI	Differences in scores of the Clinical Global Impression (CGI)	8 weeks
Secondary	Change in scores of FAST	Differences in scores of the Functioning Assessment Short Test (FAST).	8 weeks
Secondary	Depressive symptoms	Differences in scores of the Beck Depression Inventory (BDI)	8 weeks
Secondary	Anxiety symptoms	Differences in scores of the Beck Anxiety Inventory (BAI)	8 weeks
Secondary	BDNF	Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)	8 weeks
Secondary	GSSG	Differences between groups regarding dosage of Oxidized Glutathione (GSSG)	8 weeks
Secondary	GSH	Differences between groups regarding dosage of Glutathione (GSH)	8 weeks
Secondary	GPx	Differences between groups regarding dosage of Glutathione Peroxidase (GPx)	8 weeks
Secondary	CAT	Differences between groups regarding dosage of Catalase (CAT)	8 weeks
Secondary	TBARS	Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)	8 weeks
Secondary	SOD	Differences between groups regarding dosage of Superoxide Dismutase (SOD)	8 weeks
Secondary	Carbonyl	Differences between groups regarding dosage of Carbonyl	8 weeks