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Methamphetamine Dependence in RemissionPhase 2/3NCT04405193

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

A Phase 2/3 study testing N-acetyl cysteine in people with Methamphetamine Dependence in Remission, run by Melva Louisa at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Methamphetamine Dependence in Remission
What is being tested?
N-acetyl cysteine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteIndonesia
Study dates
1 Oct 2019to 30 Dec 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rehabilitation Center, National Narcotics Agency

    Bogor, West Java, 16110

Other trials in Indonesia

About this study

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.

Read the 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.

Being tested
N-acetyl cysteine, Placebo
Keywords
methamphetamine, N-acetylcysteine, substance abuse
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-acetyl cysteineDrug

    Also called Placebo

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

  • PlaceboDrug

    Matching Placebo

Study groups in NCT04405193
Study groupRoleWhat they receive
TreatmentExperimental2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.
Receives: Drug: N-acetyl cysteine
PlaceboPlacebo comparator2 capsules of matching placebo administered once daily every morning
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from baseline at 1 week.

  2. 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

    Measured: Change from baseline at 2 weeks

  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

    Measured: Change from baseline at 4 weeks

Secondary outcomes (4)

  1. Antioxidative effects of N-acetylcysteine vs placebo

    antioxidative effects will be measured by quantifying malondialdehyde plasma concentrations (micromol/L).

    Measured: Change from baseline at 4 weeks

  2. Safety of N-acetylcysteine vs placebo

    The number of subjects with adverse events at week 1

    Measured: Subjects with adverse events at week 1

  3. Safety of N-acetylcysteine vs placebo

    The number of subjects with adverse events at week 2

    Measured: Subjects with adverse events at week 2

  4. Safety of N-acetylcysteine vs placebo

    The number of subjects with adverse events at week 4

    Measured: Subjects with adverse events at week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2020
  2. Study start1 Oct 2019
  3. Primary completion30 Jul 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04405193
Sponsor's protocol ID
UI-BNN
Status last verified
Feb 2021
First submitted
21 Apr 2020
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results will be published in peer-reviewed journal

Publications

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

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

    PubMed 17990840

  • 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.

    PubMed 28302577

  • 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.

    PubMed 27927042

  • 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.

    PubMed 27241765

  • 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.

    PubMed 28213190

  • 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.

    PubMed 20655182

  • 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.

    PubMed 25556383

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing N-acetyl cysteine in people with Methamphetamine Dependence in Remission, run by Melva Louisa at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo (time frame: Change from baseline at 1 week.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04405193, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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