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

Methamphetamine Dependence in Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405193
• Other study ID #: UI-BNN
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Methamphetamine Dependence in Remission
• Substance Withdrawal Syndrome

Intervention

Drug:
• N-acetyl cysteine
Eligible patients will be randomised to receive N-acetylcysteine or placebo
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Indonesia	Rehabilitation Center, National Narcotics Agency	Bogor	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Melva Louisa

Country where clinical trial is conducted

Indonesia, 

References & Publications (8)

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. Review. — View 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. — View Citation

Ling W, Mooney L, Haglund M. Treating methamphetamine abuse disorders. Curr Psychiatry. 2014; 13(9): 37 - 44.

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. — View 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. doi: 0151801/AIM.008. — View 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. Review. — View 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. Review. — View Citation

Winslow BT, Voorhees KI, Pehl KA. Methamphetamine abuse. Am Fam Physician. 2007 Oct 15;76(8):1169-74. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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
Secondary	Safety of N-acetylcysteine vs placebo	The number of subjects with adverse events at week 1	Subjects with adverse events at week 1
Secondary	Safety of N-acetylcysteine vs placebo	The number of subjects with adverse events at week 2	Subjects with adverse events at week 2
Secondary	Safety of N-acetylcysteine vs placebo	The number of subjects with adverse events at week 4	Subjects with adverse events at week 4