A double blind, randomized, placebo controlled four way cross-over trial to investigate the effects of metoclopramide on central vasopressin release and HPA-axis activation - Metoclopramide effects on vasopressin and HPA-axis.

Centre for Human Drug Research0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•Age of 18-45 years (extremes included);
•Able and willing to sign the Informed Consent Form prior to screening evaluations; Able to refrain from use of all (methyl)xanthines (e.g. coffee, tea, cola, chocolate) from admission at 22h00 prior to each study day and during each stay at the CHDR clinic;
•Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic;
•Able to refrain from strenuous physical exercise from 48-hours prior to each dosing until dismissal from the CHDR clinic;
•No disturbed day/night rhythm due to e.g. working in night-shifts or traveling over time zones within 3 weeks prior to the first dose;
•Use of no prescribed drug (especially psychotropic drugs) within two weeks preceding the first dose, excluding paracetamol and certain dermatological preparations (as to judgement of research physician);
•Using a current daily average of less than 4 Units alcohol, or maximally consuming less than 6 U alcohol per occasion of alcohol use;
•Using a current daily average of less than 4 Units (methyl)xanthines (e.g. coffee, tea, cola, chocolate);
•Smoking less than 5 cigarettes per day;
•No past or present recreational use of methamphetamines, MDMA or *ecstasy*;
•No history of drug sensitivity.

•A body mass index (BMI) of less than 18 or more than 28 (extremes included) and a body weight of less than 60 kg;
•(History of) physical and mental illness as determined by history taking, physical and laboratory examinations, ECG and vital signs recordings;
•Clinically significant pulmonary, cardiac, renal, hepatic, neurological (including epilepsy), endocrinological or gastrointestinal disease;
•History of movement disorder (including movement disorder due to D-antagonists);
•Past or present clinically significant DSM-IV psychiatric disorder and/or substance abuse disorder, as diagnosed by GP or psychiatrist;
•Parents, children or siblings with a psychiatric disease as diagnosed by GP or psychiatrist;
•Use of illicit drugs within two weeks prior to screening;
•Positive drug (morphine, benzodiazepines, cocaine, amphetamine, THC, metamphetamines, MDMA) or alcohol screen at screening and or/admission;
•Blood donation within 90 days prior to the first dose;
•Participation in an investigational drug study within 90 days prior to the first dose, or in four studies (or more) in the past year;
•Positive test result on hepatitis B surface antigen or hepatitis C antibodies;
•Positive test result on HIV 1/2 serology

发起方