The effects of THC on Resting State fMRI.
- Conditions
- Resting State fMRIPharmacologyTHCPK/PD
- Registration Number
- NL-OMON20151
- Lead Sponsor
- CHDR in cooperation with LUMC
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1.Subject is a legally competent Caucasian male/female from 18 up to and including 45 years old (extremes included) on the day the informed consent is signed.
2.Subject is right-handed.
Exclusion Criteria
1.Subject has a BMI below 18 or above 28.5 kg/m2.
2.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Resting state network (RSN) activity<br><br /><br>- Arterial spin labeling (ASL)<br><br /><br>- THC and its metabolites 11-hydroxy-THC and 11-nor-9-carboxy-THC <br><br />
- Secondary Outcome Measures
Name Time Method - Visual Analogue Scale (VAS) mood & alertness (Bond and Lader)<br /><br>- VAS feeling high, internal & external perception (Bowdle)<br /><br>- Heart rate<br /><br>- Prolactin, LH, FSH, cortisol levels<br /><br>