EUCTR2015-000222-11-GB
进行中（未招募）
1 期
A phase II, randomised, double-blind, placebo- controlled, multi-site, parallel group clinical trial to examine ketamine as a pharmacological treatment for alcohol dependence in an alcohol dependent population. - KARE: Ketamine for reduction of Alcoholic Relapse Version 1
niversity College London0 个研究点目标入组 96 人2020年7月30日
相关药物Ketalar
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- niversity College London
- 入组人数
- 96
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •18 \- 60 years old
- •Meet either a) DSM\-5 criteria for severe alcohol use disorder and b) DSM\-IV criteria for alcohol dependence
- •Currently abstinent (breathlyser BAC level 0\.02 and negative urine drug and alcohol screen)
- •Minimum of mild depression(\>14 on Beck Depression Inventory\-II)
- •Capacity to give informed consent as defined by GCP guidelines
- •Willing and able to wear a SCRAM\-X bracelet for 6 months
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment and on day of first treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
排除标准
- •Currently taking any other relapse prevention medication or anti\-depressants
- •Uncontrolled hypertension, systolic 140mm Hg or greater and diastolic 90mm Hg or greater
- •\< 16 or \> 35 BMI
- •History of psychosis, or in a first\-degree relative; co\-morbid current psychiatric diagnosis excluding depression as identified by DSM\-5 or DSM\-IV SCID
- •Previous or current diagnosis of substance dependence / severe substance misuse disorder
- •History of neuropsychological difficulties
- •One or more previous confirmed seizures
- •Currently taking daily prescribed medication contraindicated in the Summary of Product Characteristics with ketamine:
- •Barbiturates and/or narcotics
- •Halogenated anaesthetics
结局指标
主要结局
未指定
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