Alcohol Addiction, Cocaine Addiction
Conditions
Keywords
cocaine, alcohol, substance use disorders, addiction, N-acetylcysteine, 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.
Interventions
DRUGAlcohol N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
DRUGAlcohol Placebo
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
DRUGCocaine N-acetylcysteine
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
DRUGCocaine Placebo
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
Sponsors
Secretaria Nacional de Políticas sobre Drogas (SENAD)
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who attended all study appointments | 8 weeks | Completers (i.e. subjects who attended all study appointments) vs non-completers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence by urine | 8 weeks | Amount of positive urine tests for cocaine users |
| Abstinence by breathalyzer | 8 weeks | Amount of positive breathalyzer tests for alcohol users |
| Abstinence by self report | 8 weeks | Timeline Followback Method |
| Days of inpatient treatment | 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 | 8 weeks | Differences in scores of the Clinical Global Impression (CGI) |
| Change in scores of FAST | 8 weeks | Differences in scores of the Functioning Assessment Short Test (FAST). |
| Depressive symptoms | 8 weeks | Differences in scores of the Beck Depression Inventory (BDI) |
| Anxiety symptoms | 8 weeks | Differences in scores of the Beck Anxiety Inventory (BAI) |
| GSSG | 8 weeks | Differences between groups regarding dosage of Oxidized Glutathione (GSSG) |
| GSH | 8 weeks | Differences between groups regarding dosage of Glutathione (GSH) |
| GPx | 8 weeks | Differences between groups regarding dosage of Glutathione Peroxidase (GPx) |
| CAT | 8 weeks | Differences between groups regarding dosage of Catalase (CAT) |
| TBARS | 8 weeks | Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS) |
| SOD | 8 weeks | Differences between groups regarding dosage of Superoxide Dismutase (SOD) |
| Carbonyl | 8 weeks | Differences between groups regarding dosage of Carbonyl |
| BDNF | 8 weeks | Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 8 weeks | Systematic Assessment for Treatment Emergent Events (SAFTEE) application |
Countries
Brazil
Contacts
Primary ContactLisia von Diemen, PhD
Backup ContactThiago C Hartmann, MsC
Outcome results
None listed