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

February 9, 2021 updated by: Melva Louisa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bogor, West Java, Indonesia, 16110
        • Rehabilitation Center, National Narcotics Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.
Drug: N-acetyl cysteine
Eligible patients will be randomised to receive N-acetylcysteine or placebo
Other Names:
  • Placebo
Placebo Comparator: Placebo
2 capsules of matching placebo administered once daily every morning
Drug: Placebo
Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
Time Frame: Change from baseline at 1 week.
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
Time Frame: Change from baseline at 2 weeks
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
Time Frame: Change from baseline at 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antioxidative effects of N-acetylcysteine vs placebo
Time Frame: Change from baseline at 4 weeks
antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L).
Change from baseline at 4 weeks
Safety of N-acetylcysteine vs placebo
Time Frame: Subjects with adverse events at week 1
The number of subjects with adverse events at week 1
Subjects with adverse events at week 1
Safety of N-acetylcysteine vs placebo
Time Frame: Subjects with adverse events at week 2
The number of subjects with adverse events at week 2
Subjects with adverse events at week 2
Safety of N-acetylcysteine vs placebo
Time Frame: Subjects with adverse events at week 4
The number of subjects with adverse events at week 4
Subjects with adverse events at week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melva Louisa

Investigators

  • Study Chair: Erniawati Lestari, MD, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UI-BNN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The results will be published in peer-reviewed journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Methamphetamine Dependence in Remission

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe