|- candidate number||28295|
|- NTR Number||NTR6893|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-dec-2017|
|- Secondary IDs||METC NL63520.041.17 |
|- Public Title||The effect of cannabidiol (300 mg) on fear conditioning.|
|- Scientific Title||The effect of cannabidiol in facilitating fear extinction and in attenuating fear retention and reinstatement in humans.|
|- Healt Condition(s) or Problem(s) studied||Anxiety, 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.
- Reduced startle reactivity, defined as no discernable response in at least 3 out of the 12 startle stimuli presented at screening.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-jan-2019|
|- Target number of participants||56|
|- Interventions||Capsule with 300 mg cannabidiol of placebo|
|- Primary outcome||Both 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 outcome||n.a.|
|- Timepoints||fear acquisition, fear expression, fear extinction, fear retention, reinstatement|
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES|| Febe Flier, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Joke Baas|
|- Sponsor/Initiator ||Utrecht University (UU)|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||4-dec-2017 - 29-dec-2017|