The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Matching placebo
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment
2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.
干预措施: N-acetyl cysteine (Drug)
Placebo
2 capsules of matching placebo administered once daily every morning
干预措施: Placebo (Drug)
结局指标
主要结局
Methamphetamine withdrawal symptoms in patients treated with N-acetylcysteine vs placebo
时间窗: 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
次要结局
- 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 4)
研究者
Melva Louisa
Dr Melva Louisa, SSi, MBiomed; Research Coordinator for the Department of Pharmacology and Therapeutics, Primary Investigator
Indonesia University