The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
NCT ID: NCT04405193
Last Updated: 2021-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
66 participants
INTERVENTIONAL
2019-10-01
2020-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment
2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.
N-acetyl cysteine
Eligible patients will be randomised to receive N-acetylcysteine or placebo
Placebo
2 capsules of matching placebo administered once daily every morning
Placebo
Matching Placebo
Interventions
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N-acetyl cysteine
Eligible patients will be randomised to receive N-acetylcysteine or placebo
Placebo
Matching Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Melva Louisa
OTHER
Responsible Party
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Melva Louisa
Dr Melva Louisa, SSi, MBiomed; Research Coordinator for the Department of Pharmacology and Therapeutics, Primary Investigator
Principal Investigators
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Erniawati Lestari, MD
Role: STUDY_CHAIR
Indonesia University
Locations
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Rehabilitation Center, National Narcotics Agency
Bogor, West Java, Indonesia
Countries
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References
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Ling W, Mooney L, Haglund M. Treating methamphetamine abuse disorders. Curr Psychiatry. 2014; 13(9): 37 - 44.
Winslow BT, Voorhees KI, Pehl KA. Methamphetamine abuse. Am Fam Physician. 2007 Oct 15;76(8):1169-74.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UI-BNN
Identifier Type: -
Identifier Source: org_study_id
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