NL-OMON32445已完成不适用
A randomized, double blind, placebo-controlled, 2-way cross-over study to investigate the effects of inhaled THC on resting state functional magnetic resonance imaging in healthy volunteers - THC ph-fMRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Caucasian, legally competent adult from 18 up to and including 45 years old.
- •- able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent.
- •- 3. Subject is a mild cannabis user for at least one year: cannabis use of no more than once a week, and able to refrain from using cannabinoids from at least 2 weeks prior to the first treatment period to the end of the follow-up period
排除标准
- •- Subject has a BMI below 18 or above 28.5 kg/m2.
- •- Subject has a significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, neurological, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease or uses any kind of concomitant medication that - in the opinion of the investigator - may interfere with the study.
- •- Subject has a (history of) a significant medical disorder that may pose a risk for the subject or jeopardize the aims of the study, based on medical history, physical examination, ECG and safety laboratory parameters.
- •- Subject has a history of clinically significant psychiatric or neurological illness in first- degree relatives.
- •- Female subjects not using the Nuvaring® nor one of the monophasic oral contraceptives (including Diane-35), who are unable and unwilling to also skip the pill/ring-free week, from the screening until the end of the study.
- •- Pregnant or breast feeding subjects.
- •- Left-handed handed subjects
- •- History of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds
- •- Drug-, medication-, alcohol-, nicotine-, grape-fruit-, quinine- or xanthine use that is no according to protocol
- •- Claustophobia
- •- Participation in an investigational drug study within 90 days prior to the first dose and/or participation in more than 4 clinical trials in the last year.
- •- Donation of blood/plasma outside limits of Sanquin Blood Supply Foundation guidelines.
- •- Subject is provided with a metal medical device like pacemaker, knee or hip prosthesis, ear-implant, vessel-clip, subcutaneous insulin pump, or carries metal particles (e.g. metal splinter in the eye) inside the body.
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