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
- Conditions
- Er zal bij deze studie niet gekeken worden naar de aandoening die het middel behandelt. De farmacodynamische effecten van THC op neurale netwerken in rust zullen worden bestudeerd.Neural resting state networks
- Registration Number
- NL-OMON32445
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
- 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
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamics:<br /><br>*<br /><br>- Resting state network (RSN) activity<br /><br>*- Arterial spin labeling (ASL): whole brain, voxel-wise cerebral blood flow<br /><br>(CBF) (milliliters of blood per 100g of tissue per minute) and CBF changes<br /><br>due to drug administration<br /><br>*- 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>*<br /><br><br /><br>Pharmacokinetics:<br /><br>*<br /><br>-THC and its metabolites 11-hydroxy-THC and 11-nor-9-carboxy-THC </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>