The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms

Conditions
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Methamphetamine Dependence in Remission

Intervention / Treatment
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* Drug: N-acetyl cysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning. | Drug: N-acetyl cysteine<br>* Eligible patients will be randomised to receive N-acetylcysteine or placebo<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>2 capsules of matching placebo administered once daily every morning | Drug: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidative effects of N-acetylcysteine vs placebo | antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L). | Change from baseline at 4 weeks | 
| Safety of N-acetylcysteine vs placebo | The number of subjects with adverse events at week 1 | Subjects with adverse events at week 1 | 
| Safety of N-acetylcysteine vs placebo | The number of subjects with adverse events at week 2 | Subjects with adverse events at week 2 | 
| Safety of N-acetylcysteine vs placebo | The number of subjects with adverse events at week 4 | Subjects with adverse events at week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methamphetamine, N-acetylcysteine, substance abuse