Methamphetamine Dependence in Remission
Conditions
Keywords
methamphetamine, N-acetylcysteine, substance abuse
Brief summary
Up to date, no approved medications are available for the treatment of methamphetamine addiction. Recently, N-acetylcysteine is recently being studied for methamphetamine withdrawal. N-acetylcysteine, is a drug that has been long used as a mucolytic. Recent studies investigate the use of N-acetylcysteine in cocaine and withdrawal symptoms by its effect on restoring glutamate homeostasis in nucleus accumbens. Up to date, there has been 2 pilot study investigating the efficacy of N-acetylcysteine for methamphetamine dependence. The present study is aimed to confirm the efficacy and safety of N-acetylcysteine in the treatment of methamphetamine withdrawal symptoms.
Detailed description
Methamphetamine is a stimulant commonly abused worldwide. Methamphetamine can produce a rapid pleasurable rush caused by release of dopamine, nor-ephinephrine and serotonin. It produces euphoria, a heightened level of alertness and increased level of alertness and increased energy. Long-term regular meth use can lead to severe tooth decay, infection, weight loss, malnutrition, kidney damage, liver damage, respiratory issues, paranoia, violent behaviour, psychosis, severe anxiety and depression. Studies suggested that withdrawal symptoms in methamphetamine dependent patients were due to the state of hypodopaminergic activities. Up to date, no approved medications are available for the treatment of methamphetamine addiction. Recently, N-acetylcysteine is recently being studied for methamphetamine withdrawal. N-acetylcysteine, is a drug that has been long used as a mucolytic. Up to date, there has been 2 pilot study investigating the efficacy of N-acetylcysteine for methamphetamine dependence. The present study is aimed to confirm the efficacy and safety of N-acetylcysteine in the treatment of methamphetamine withdrawal symptoms.
Interventions
DRUGN-acetyl cysteine
Eligible patients will be randomised to receive N-acetylcysteine or placebo
DRUGPlacebo
Matching Placebo
Sponsors
Melva Louisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Matching placebo
Intervention model description
Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Men or women, 18 - 60 years old * Diagnosed with methamphetamine addiction based on DSM-V criteria, enrolling for methamphetamine withdrawal treatment * Agree to participate in the trial by signing informed consent
Exclusion criteria
* Known hypersensitivity to N-acetylcysteine * Patients with serious conditions that will not allow protocol compliance or safe participation in the clinical trials. * Pregnant or breastfeeding women * History of suicidal thoughts / behaviour * History of N-acetylcysteine treatment * History of asthma and convulsions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo | Change from baseline at 1 week. | Withdrawal symptoms will be measured using Addiction Severity Index (ASI). ASI score ranged from 0 to 9, with score of 0 indicates no withdrawal symptoms and 9 indicates extreme symptoms of withdrawal symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidative effects of N-acetylcysteine vs placebo | Change from baseline at 4 weeks | antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L). |
| Safety of N-acetylcysteine vs placebo | Subjects with adverse events at week 1 | The number of subjects with adverse events at week 1 |
Countries
Indonesia
Outcome results
None listed