Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-01 @ 3:11 PM
Study NCT ID:
NCT04405193
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2020-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Matching placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo', 'timeFrame': 'Change from baseline at 1 week.', 'description': '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'}, {'measure': 'Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo', 'timeFrame': 'Change from baseline at 2 weeks', 'description': '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'}, {'measure': 'Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo', 'timeFrame': 'Change from baseline at 4 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Antioxidative effects of N-acetylcysteine vs placebo', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L).'}, {'measure': 'Safety of N-acetylcysteine vs placebo', 'timeFrame': 'Subjects with adverse events at week 1', 'description': 'The number of subjects with adverse events at week 1'}, {'measure': 'Safety of N-acetylcysteine vs placebo', 'timeFrame': 'Subjects with adverse events at week 2', 'description': 'The number of subjects with adverse events at week 2'}, {'measure': 'Safety of N-acetylcysteine vs placebo', 'timeFrame': 'Subjects with adverse events at week 4', 'description': 'The number of subjects with adverse events at week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['methamphetamine', 'N-acetylcysteine', 'substance abuse'], 'conditions': ['Methamphetamine Dependence in Remission']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ling W, Mooney L, Haglund M. Treating methamphetamine abuse disorders. Curr Psychiatry. 2014; 13(9): 37 - 44.'}, {'pmid': '17990840', 'type': 'BACKGROUND', 'citation': 'Winslow BT, Voorhees KI, Pehl KA. Methamphetamine abuse. Am Fam Physician. 2007 Oct 15;76(8):1169-74.'}, {'pmid': '28302577', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27927042', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27241765', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28213190', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20655182', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25556383', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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\nN-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.\n\nThe present study is aimed to confirm the efficacy and safety of N-acetylcysteine in the treatment of methamphetamine withdrawal symptoms.', 'detailedDescription': '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.\n\nStudies suggested that withdrawal symptoms in methamphetamine dependent patients were due to the state of hypodopaminergic activities.\n\nUp to date, no approved medications are available for the treatment of methamphetamine addiction. Recently, N-acetylcysteine is recently being studied for methamphetamine withdrawal.\n\nN-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women, 18 - 60 years old\n* Diagnosed with methamphetamine addiction based on DSM-V criteria, enrolling for methamphetamine withdrawal treatment\n* Agree to participate in the trial by signing informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to N-acetylcysteine\n* Patients with serious conditions that will not allow protocol compliance or safe participation in the clinical trials.\n* Pregnant or breastfeeding women\n* History of suicidal thoughts / behaviour\n* History of N-acetylcysteine treatment\n* History of asthma and convulsions'}, 'identificationModule': {'nctId': 'NCT04405193', 'briefTitle': 'The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms', 'orgStudyIdInfo': {'id': 'UI-BNN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.', 'interventionNames': ['Drug: N-acetyl cysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 capsules of matching placebo administered once daily every morning', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'N-acetyl cysteine', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Eligible patients will be randomised to receive N-acetylcysteine or placebo', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bogor', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Rehabilitation Center, National Narcotics Agency', 'geoPoint': {'lat': -6.59444, 'lon': 106.78917}}], 'overallOfficials': [{'name': 'Erniawati Lestari, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The results will be published in peer-reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melva Louisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr Melva Louisa, SSi, MBiomed; Research Coordinator for the Department of Pharmacology and Therapeutics, Primary Investigator', 'investigatorFullName': 'Melva Louisa', 'investigatorAffiliation': 'Indonesia University'}}}}