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Completed

NCT Number: NCT04405193

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

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.

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Key information

Conditions

Methamphetamine Dependence in Remission Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rehabilitation Center, National Narcotics Agency

Bogor, West Java, 16110, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetyl cysteine

Drug

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

Other names: Placebo

Placebo

Drug

Matching Placebo

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Melva Louisa

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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