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临床试验/NCT01563224
NCT01563224已完成不适用

GABA-B Receptor Function in Healthy Volunteers: a Pilot, Double Blind Crossover Study of the Effects of 2 Doses of Baclofen and Placebo on Objective and Subjective Measurements of Brain Function

Imperial College London1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
EEG spectral power in theta band

研究概览

简要总结

There are several developing lines of evidence suggesting that brain receptors called GABA-B receptors play a significant role in addiction and its treatment. The investigators wish to examine the sensitivity of brain GABA-B receptors in alcohol and opiate addicts as part of the investigators MRC programme of research in neurotransmitters in alcohol and opiate addiction (NOAA). In this present study the investigators will give 2 different single doses of a drug called baclofen, and a placebo, to 8 healthy male volunteers. This drug affects GABA-B receptors in the central nervous system and is licensed for the treatment of spasticity in people with eg spinal injuries; the investigators are interested in its effects on brain GABA-B receptors. The investigators will measure EEG (brainwaves), eye movements, blood pressure and heart rate, motor co-ordination and subjective effects and also blood levels of the drug in the investigators volunteers before and at intervals after dosing. The investigators will use a double-blind randomised design to minimise expectation effects. The study will provide information on timing and magnitude of effects of baclofen on brain function in healthy subjects so that the investigators can optimise selection and timing of functional measures in future studies of addicts.

详细描述

After informed consent and screening participants will attend for 3 study days. On each of these there will be a set of baseline measurements including EEG, saccadic eye movements, vital signs, motor co-ordination task, subjective visual analogue ratings and questionnaires and blood sample. After dosing these measurements will be repeated at intervals during the day up to 6 hours after dosing. Participants will be allowed home after a health check.

研究设计

研究类型
Interventional
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Currently healthy
  • Non-smoker
  • Willing to comply with protocol
  • Excellent understanding of English (for questionnaires)
  • Alcohol consumption between 1 and 28 units/week

排除标准

  • Current or past history of psychiatric or substance use disorder

研究组 & 干预措施

single group, crossover, 3 interventions

Experimental

干预措施: Baclofen 60mg (Drug)

single group, crossover, 3 interventions

Experimental

干预措施: Baclofen 10mg (Drug)

single group, crossover, 3 interventions

Experimental

干预措施: placebo (Drug)

结局指标

主要结局

EEG spectral power in theta band

时间窗: Change from baseline to 4 hours after dosing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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