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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
Eligible patients will be randomised to receive N-acetylcysteine or placebo
Matching Placebo
Rehabilitation Center, National Narcotics Agency
Bogor, West Java, Indonesia
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
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
Time frame: Change from baseline at 1 week.
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
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
Time frame: Change from baseline at 2 weeks
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
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
Time frame: Change from baseline at 4 weeks
Antioxidative effects of N-acetylcysteine vs placebo
antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L).
Time frame: Change from baseline at 4 weeks
Safety of N-acetylcysteine vs placebo
The number of subjects with adverse events at week 1
Time frame: Subjects with adverse events at week 1
Safety of N-acetylcysteine vs placebo
The number of subjects with adverse events at week 2
Time frame: Subjects with adverse events at week 2
Safety of N-acetylcysteine vs placebo
The number of subjects with adverse events at week 4
Time frame: Subjects with adverse events at week 4
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