The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
- Conditions
- Methamphetamine Dependence in Remission
- Interventions
- Drug: Placebo
- Registration Number
- NCT04405193
- Lead Sponsor
- Melva Louisa
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment N-acetyl cysteine 2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning. Placebo Placebo 2 capsules of matching placebo administered once daily every morning
- Primary Outcome Measures
Name Time Method Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo Change from baseline at 4 weeks 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 Outcome Measures
Name Time Method 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 4 The number of subjects with adverse events at week 4
Trial Locations
- Locations (1)
Rehabilitation Center, National Narcotics Agency
🇮🇩Bogor, West Java, Indonesia