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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning. |
|
| Placebo | Placebo Comparator | 2 capsules of matching placebo administered once daily every morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl cysteine | Drug | Eligible patients will be randomised to receive N-acetylcysteine or placebo |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erniawati Lestari, MD | Indonesia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Center, National Narcotics Agency | Bogor | West Java | 16110 | Indonesia |
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The results will be published in peer-reviewed journal
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo
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Matching placebo
| Placebo | Drug | Matching 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 |
| Background |
| Prakash MD, Tangalakis K, Antonipillai J, Stojanovska L, Nurgali K, Apostolopoulos V. Methamphetamine: Effects on the brain, gut and immune system. Pharmacol Res. 2017 Jun;120:60-67. doi: 10.1016/j.phrs.2017.03.009. Epub 2017 Mar 14. |
| 27927042 | Background | Ballester J, Valentine G, Sofuoglu M. Pharmacological treatments for methamphetamine addiction: current status and future directions. Expert Rev Clin Pharmacol. 2017 Mar;10(3):305-314. doi: 10.1080/17512433.2017.1268916. Epub 2016 Dec 20. |
| 27241765 | Background | McKetin R, Dean OM, Baker AL, Carter G, Turner A, Kelly PJ, Berk M. A potential role for N-acetylcysteine in the management of methamphetamine dependence. Drug Alcohol Rev. 2017 Mar;36(2):153-159. doi: 10.1111/dar.12414. Epub 2016 May 30. |
| 28213190 | Background | Nocito Echevarria MA, Andrade Reis T, Ruffo Capatti G, Siciliano Soares V, da Silveira DX, Fidalgo TM. N-acetylcysteine for treating cocaine addiction - A systematic review. Psychiatry Res. 2017 May;251:197-203. doi: 10.1016/j.psychres.2017.02.024. Epub 2017 Feb 11. |
| 20655182 | Background | Grant JE, Odlaug BL, Kim SW. A double-blind, placebo-controlled study of N-acetyl cysteine plus naltrexone for methamphetamine dependence. Eur Neuropsychopharmacol. 2010 Nov;20(11):823-8. doi: 10.1016/j.euroneuro.2010.06.018. Epub 2010 Jul 22. |
| 25556383 | Background | Mousavi SG, Sharbafchi MR, Salehi M, Peykanpour M, Karimian Sichani N, Maracy M. The efficacy of N-acetylcysteine in the treatment of methamphetamine dependence: a double-blind controlled, crossover study. Arch Iran Med. 2015 Jan;18(1):28-33. |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |