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

NCT04405193 | Completed Phase 2

• 1 other identifier: UI-BNN
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence in Remission

Keywords

methamphetamine; N-acetylcysteine; substance abuse

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Antioxidative effects of N-acetylcysteine vs placebo

  Change from baseline at 4 weeks

• Safety of N-acetylcysteine vs placebo

  Subjects with adverse events at week 1

• Safety of N-acetylcysteine vs placebo

  Subjects with adverse events at week 2

• Safety of N-acetylcysteine vs placebo

  Subjects with adverse events at week 4

Study Arms (2)

Treatment

EXPERIMENTAL

2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.

Drug: N-acetyl cysteine

Placebo

PLACEBO COMPARATOR

2 capsules of matching placebo administered once daily every morning

Drug: Placebo

Interventions

N-acetyl cysteine DRUG

Eligible patients will be randomised to receive N-acetylcysteine or placebo

Also known as: Placebo

Treatment

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Melva Louisa: lead

Study Sites (1)

Rehabilitation Center, National Narcotics Agency

Bogor, West Java, 16110, Indonesia

Location

Related Publications (8)

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

  BACKGROUND

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

  PMID: 17990840 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.

  PMID: 28302577 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.

  PMID: 27927042 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.

  PMID: 27241765 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.

  PMID: 28213190 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.

  PMID: 20655182 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.

  PMID: 25556383 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Erniawati Lestari, MD

  Indonesia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Melva Louisa, SSi, MBiomed; Research Coordinator for the Department of Pharmacology and Therapeutics, Primary Investigator

Model Details: Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 28, 2020
• Study Start: October 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)