The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
Primary Purpose
Methamphetamine Dependence in Remission
Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
N-acetyl cysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Methamphetamine Dependence in Remission focused on measuring methamphetamine, N-acetylcysteine, substance abuse
Eligibility Criteria
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
Sites / Locations
- Rehabilitation Center, National Narcotics Agency
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.
2 capsules of matching placebo administered once daily every morning
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Antioxidative effects of N-acetylcysteine vs placebo
antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L).
Safety of N-acetylcysteine vs placebo
The number of subjects with adverse events at week 1
Safety of N-acetylcysteine vs placebo
The number of subjects with adverse events at week 2
Safety of N-acetylcysteine vs placebo
The number of subjects with adverse events at week 4
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04405193
Brief Title
The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
Official Title
The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Melva Louisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine Dependence in Remission
Keywords
methamphetamine, N-acetylcysteine, substance abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Matching placebo
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules of matching placebo administered once daily every morning
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Other Intervention Name(s)
Placebo
Intervention Description
Eligible patients will be randomised to receive N-acetylcysteine or placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
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
Time Frame
Change from baseline at 1 week.
Title
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
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
Time Frame
Change from baseline at 2 weeks
Title
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
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
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Antioxidative effects of N-acetylcysteine vs placebo
Description
antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L).
Time Frame
Change from baseline at 4 weeks
Title
Safety of N-acetylcysteine vs placebo
Description
The number of subjects with adverse events at week 1
Time Frame
Subjects with adverse events at week 1
Title
Safety of N-acetylcysteine vs placebo
Description
The number of subjects with adverse events at week 2
Time Frame
Subjects with adverse events at week 2
Title
Safety of N-acetylcysteine vs placebo
Description
The number of subjects with adverse events at week 4
Time Frame
Subjects with adverse events at week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erniawati Lestari, MD
Organizational Affiliation
Indonesia University
Official's Role
Study Chair
Facility Information:
Facility Name
Rehabilitation Center, National Narcotics Agency
City
Bogor
State/Province
West Java
ZIP/Postal Code
16110
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The results will be published in peer-reviewed journal
Citations:
Citation
Ling W, Mooney L, Haglund M. Treating methamphetamine abuse disorders. Curr Psychiatry. 2014; 13(9): 37 - 44.
Results Reference
background
PubMed Identifier
17990840
Citation
Winslow BT, Voorhees KI, Pehl KA. Methamphetamine abuse. Am Fam Physician. 2007 Oct 15;76(8):1169-74.
Results Reference
background
PubMed Identifier
28302577
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.
Results Reference
background
PubMed Identifier
27927042
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.
Results Reference
background
PubMed Identifier
27241765
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.
Results Reference
background
PubMed Identifier
28213190
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.
Results Reference
background
PubMed Identifier
20655182
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.
Results Reference
background
PubMed Identifier
25556383
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.
Results Reference
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The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
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