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The effect of cannabidiol (300 mg) on fear conditioning.


- candidate number28295
- NTR NumberNTR6893
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-dec-2017
- Secondary IDsMETC NL63520.041.17 
- Public TitleThe effect of cannabidiol (300 mg) on fear conditioning.
- Scientific TitleThe effect of cannabidiol in facilitating fear extinction and in attenuating fear retention and reinstatement in humans.
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedAnxiety, Fear conditioning
- Inclusion criteria- Male or female volunteers between 18 and 30 years.
- Judged to be in good physical and mental health on the basis of the medical history according to self-report.
- Have a normal binocular acuity, corrected or uncorrected.
- Female participants must declare they are on reliable birth control.
- Exclusion criteria- History of any disease, e.g. neurological disorders, psychiatric disorders, which in the opinion of the investigator may confound the results of the study.
- Present any other conditions in that in the investigators’, the subjects’ personal or the study physicians’ opinion may confound the results of the study.
- History of psychotic disorder/psychosis and/or having a first/second degree family member with (a history of) psychotic disorder/psychosis.
- Current diagnosis of an Axis I or Axis II psychiatric disorder, or suffering from an Axis I or Axis II psychiatric disorder within 4 weeks prior to the study.
- Current cardiac disease and/or history of cardiac disease.
- Known hypersensitivity to CBD.
- History of cannabinoids exopsure with adverse reactions.
- History of severe allergy or general drug hypersensitivity.
- History of abuse or current regular use of cannabis more than once a week.
- Usage of psychoactive drugs in the four weeks prior to the study.
- Current use of drugs of abuse or indications (urine screening)
- History of epilepsy.
- Pregnancy, i.e., a positive β-HCG urine test.
- Lactating.
- Reduced startle reactivity, defined as no discernable response in at least 3 out of the 12 startle stimuli presented at screening.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2019
- Target number of participants56
- InterventionsCapsule with 300 mg cannabidiol of placebo
- Primary outcomeBoth subjective and objective parameters pertaining to fear conditioning and fear extinction will be assessed, the main physiological measure is the fear potentiated startle reflex.
- Secondary outcomen.a.
- Timepointsfear acquisition, fear expression, fear extinction, fear retention, reinstatement
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIES Febe Flier, van der
- CONTACT for SCIENTIFIC QUERIESDr. Joke Baas
- Sponsor/Initiator Utrecht University (UU)
- Funding
(Source(s) of Monetary or Material Support)
NWO, ZonMw
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-dec-2017 - 29-dec-2017


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