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临床试验/NCT02556060
NCT02556060已完成2 期

Lamotrigine for Ketamine Dependence: A Randomized, Double-Blind, Placebo-Controlled Trial

Taipei City Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Urine drug screen

研究概览

简要总结

The purpose of this study is to investigate the efficacy of lamotrigine in the treatment of ketamine dependence in a double-blind, placebo controlled design.

详细描述

Introduction

Ketamine is an anesthetic derivative of phencyclidine (PCP; 'Angel dust') with dissociative, analgesic and psychedelic properties. Recreational use of ketamine was first documented on the west coast of the United States in the early 1970s. Ketamine is frequently described as a "unique drug" because it shows hypnotic (sleep producing), analgesic (pain relieving) and amnesic (short-term memory loss) effects; no other drug used in clinical practice combines these three important features at the same time. Ketamine produces an anaesthetic state, which has been termed "dissociative anaesthesia", characterized by analgesia and changes in vigilance and perception, but it is not a sedative or hypnotic. It appears that ketamine selectively interrupts the thalamocortical system. Ketamine has some anxiolytic- and antidepressant-like properties in sub-anesthetic doses.

Mechanism of ketamine addiction

The existence of binding sites for PCP and ketamine were first identified in 1979. Earlier reports indicate that ketamine essentially blocks the N-methyl-D-aspartate (NMDA) subtype of glutamate receptors. The antagonism of NMDA receptor is responsible for its specific properties including psychedelic, anesthetic, analgesic, anxiolytic, antidepressant, hypnotic effects and cognitive impairment. In fact, ketamine also binds to non-NMDA glutamate receptors and involves glutamate-independent mechanisms associated with nicotinic and muscarinic cholinergic, monoaminergic and opioid receptors.

Currently there is no specific pharmacological treatment model for ketamine dependence. Continuous urine screen plus medications for psychiatric symptoms treatment revealed fair results.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current users of ketamine, including having a ketamine-positive urine
  • Meeting DSM-5 criteria for ketamine use disorder
  • Age between 18 to 65 years old
  • Women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.

排除标准

  • Significant medical conditions such as abnormal liver function or renal function confirmed by laboratory tests
  • Hypertension
  • A current cardiac condition or high risk of cardiovascular disease
  • Seizure disorders
  • Any another significant underlying medical condition which would contraindicate lamotrigine treatment
  • Meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders
  • Meeting DSM-IV psychiatric classifications for substance use disorder other than ketamine within three month except tobacco or caffeine.
  • Exhibiting current suicidality or homicidality
  • Pregnant women, lactating women or women who are planning to be pregnant.

研究组 & 干预措施

lamotrigine

Experimental

lamotrigine extended release up to 200 mg/day,

干预措施: Lamotrigine (Drug)

lamotrigine

Experimental

lamotrigine extended release up to 200 mg/day,

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Identical Placebo

干预措施: Lamotrigine (Drug)

Placebo

Placebo Comparator

Identical Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Urine drug screen

时间窗: 12 weeks

Negative result of urinary drug toxicology screen of ketamine

次要结局

  • subjective visual analogue scales of craving(12 weeks)
  • Retention rate(12 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lin, Shih-Ku

Chair of Department of Psychiatry

Taipei City Hospital

研究点 (1)

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