Investigating the acute effects of THC on functional brain systems - THC-phMRI
- Conditions
- This research project will be performed with healthy volunteers in order to determine whether THC modulates activity in functional brain systems.MedDRA version: 9.1Level: LLTClassification code 10007171Term: Cannabis abuse
- Registration Number
- EUCTR2006-004482-33-NL
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
• History of mild cannabis use for at least one year (<1/week and = 4/year)
• History without psychotic experiences after cannabis use
• Age between 18 and 45 years
• Right-handedness, assessed with the Edinburgh Handedness Inventory (Oldfield, 1971
• Written informed consent of the subject
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening
• Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests (see paragraph 8.3.1)
• History of clinically significant psychiatric or neurological illness
• History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
• History of alcohol and/or drug abuse (DSM-IV criteria)
• Body Mass Index (B.M.I.) between 18 and 28 kg/m2
• Paranoid ideation or psychoticism on SCL-90
• Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug
• The use of any medication within three weeks prior to the start of the study, except for paracetamol
• Positive HIV or Hepatitis B/C test
• Blood donation within 3 months before the start of the study
• Claustrophobia
• Metal objects in or around the body (braces, pacemaker, metal fragments)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether THC modulates activity in functional brain systems. We test this by assessing the acute effects of THC on the reward system, the working memory system and the associative memory system. ;Secondary Objective: • To determine the acute behavioral and physiological effects induced by THC.<br>• To investigate the relationship between plasma THC, activational pattern and behavioral data using PK/PD modeling.<br>• To investigate functional and effective connectivity between brain regions activated by THC.<br>;Primary end point(s): The investigator can decide to withdraw a subject from the study. This can be due to medical reasons, for example when serious side effects occur, or when subjects need procedures that are not allowed in the protocol. In case of repeated withdrawal of subjects for urgent medical reasons, the investigator will decide to end the study prematurely.
- Secondary Outcome Measures
Name Time Method