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Neurotransmission during THC intoxication


- candidate number20893
- NTR NumberNTR4897
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-nov-2014
- Secondary IDs 
- Public TitleNeurotransmission during THC intoxication
- Scientific TitleBrain kinetics of neurotransmission during THC intoxication
- ACRONYM
- hypothesisThe study will assess brain kinetics of glutamate, GABA and dopamine during the absorption and elimination phase of THC.
And relate THC kinetics in blood to brain kinetics of neurotransmission and subjective experiences of drug liking and wanting.
- Healt Condition(s) or Problem(s) studiedCannabis, Neurotransmission, Pharmacokinetics
- Inclusion criteria Used cannabis between 1 times a month and 1 times a week during the previous year
Age between 18 and 40 years
Free from psychotropic medication
Good physical health as determined by medical examination and laboratory analysis
Absence of any major medical, endocrine and neurological condition
Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
Written Informed Consent
Good knowledge and understanding of the Dutch language
- Exclusion criteria History of drug abuse (other than the use of cannabis) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
Pregnancy or lactation
Hypertension (diastolic> 90; systolic> 140)
Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
Liver dysfunction
(Serious) side effects to previous cannabis
History of cardiac dysfunctions (arrhythmia, ischemic heart disease,)
For women: no use of a reliable contraceptive
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate1-nov-2015
- Target number of participants20
- Interventions300 microg/kg bodyweight THC and placebo
- Primary outcomeNeurotransmission of glutamate, GABA and dopamine will be assessed using MRS and resting state fMRI.
- Secondary outcomeTHC kinetics in blood, subjective experiences of drug, and cognitive performance
- TimepointsMeasurments will take place at and after Tmax of THC
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E.L. Theunissen
- CONTACT for SCIENTIFIC QUERIES E.L. Theunissen
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-nov-2014 - 22-dec-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl