A double-blind, randomized, three-way cross-over trial to develop a pharmacologic challenge with ketamine. - ketamine-challenge

Centre for Human Drug Research0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Age between 18 and 45 (extremes included)
•Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes included)
•Mild cannabis users (defined as >= 4 times in last year and <= 1x/week in last year)
•Willing to provide informed consent to participate in the study and to comply with all study procedures

•Clinically significant (history of) disease as determined by medical history, physical examination, ECG or routine blood chemistry, hematology or virology tests.
•Clinically significant (history of) psychiatric illnesses (including substance abuse) or (history of) psychotic symptoms
•Family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree)
•Smokes more than five cigarettes a day
•Positive urine drug screen for recreational drugs (i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, MDMA or THC)
•Positive urine pregnancy test or breastfeeding
•Exposure to medication (including St. John's Wort) known to interfere with CYP3A4 metabolism within 14 days prior to dosing
•Unable or unwilling to refrain from smoking, heavy physical exercise or the use of alcohol, xanthine, or grapefruit juice 24 hours prior to dosing until discharge.
•Blood loss or donation outside the limits of the Dutch blood bank (Sanquin)
•Participation in a clinical study within the past three months, or participation within four or more clinical studies in the past twelve months

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