Clinical trial NCT04405193: The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
Official title: The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Methamphetamine Dependence in Remission
Keywords: methamphetamine
N-acetylcysteine
substance abuse
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
timeFrame: Change from baseline at 1 week.
measure: Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
timeFrame: Change from baseline at 2 weeks
measure: Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Antioxidative effects of N-acetylcysteine vs placebo
timeFrame: Change from baseline at 4 weeks
measure: Safety of N-acetylcysteine vs placebo
timeFrame: Subjects with adverse events at week 1
measure: Safety of N-acetylcysteine vs placebo
timeFrame: Subjects with adverse events at week 2
measure: Safety of N-acetylcysteine vs placebo
timeFrame: Subjects with adverse events at week 4
Other outcomes:
Locations:
city: Bogor
country: Indonesia
facility: Rehabilitation Center, National Narcotics Agency
state: West Java
Study officials:
affiliation: Indonesia University
name: Erniawati Lestari, MD
role: STUDY_CHAIR
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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.
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.