A Phase 4 interventional study of Alcohol N-acetylcysteine and Alcohol Placebo in Cocaine Addiction and Alcohol Addiction, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 4, Interventional, and Treatment
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.
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.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Drug: Alcohol N-acetylcysteine
A placebo capsule matching color and smell of the active medication
Drug: Alcohol Placebo
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
Drug: Cocaine N-acetylcysteine
A placebo capsule matching color and smell of the active medication
Drug: Cocaine Placebo
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
Also known as: NAC
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
Also known as: NAC
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
Number of participants who attended all study appointments
Completers (i.e. subjects who attended all study appointments) vs non-completers
Time frame: 8 weeks
Abstinence by urine
Amount of positive urine tests for cocaine users
Time frame: 8 weeks
Abstinence by breathalyzer
Amount of positive breathalyzer tests for alcohol users
Time frame: 8 weeks
Abstinence by self report
Timeline Followback Method
Time frame: 8 weeks
Days of inpatient treatment
The difference (if any) between placebo and intervention groups in the amount of inpatient treatment days.
Time frame: Up to 4 weeks
Change in scores of CGI
Differences in scores of the Clinical Global Impression (CGI)
Time frame: 8 weeks
Change in scores of FAST
Differences in scores of the Functioning Assessment Short Test (FAST).
Time frame: 8 weeks
Depressive symptoms
Differences in scores of the Beck Depression Inventory (BDI)
Time frame: 8 weeks
Anxiety symptoms
Differences in scores of the Beck Anxiety Inventory (BAI)
Time frame: 8 weeks
BDNF
Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)
Time frame: 8 weeks
GSSG
Differences between groups regarding dosage of Oxidized Glutathione (GSSG)
Time frame: 8 weeks
GSH
Differences between groups regarding dosage of Glutathione (GSH)
Time frame: 8 weeks
GPx
Differences between groups regarding dosage of Glutathione Peroxidase (GPx)
Time frame: 8 weeks
CAT
Differences between groups regarding dosage of Catalase (CAT)
Time frame: 8 weeks
TBARS
Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)
Time frame: 8 weeks
SOD
Differences between groups regarding dosage of Superoxide Dismutase (SOD)
Time frame: 8 weeks
Carbonyl
Differences between groups regarding dosage of Carbonyl
Time frame: 8 weeks
Adverse events
Systematic Assessment for Treatment Emergent Events (SAFTEE) application
Time frame: 8 weeks
Plan to share: Undecided
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre