|- candidate number||22397|
|- NTR Number||NTR5266|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jun-2015|
|- Secondary IDs||METC NL49138.041.14|
|- Public Title||The effect of cannabidiol (40mg) on fear conditioning|
|- Scientific Title||The effect of cannabidiol in facilitating fear extinction and in attenuating fear retention and reinstatement|
|- hypothesis||The objective is to investigate the effect of cannabidiol (synthetic) as compared to placebo in facilitating fear extinction and reducing fear retention and reinstatement.|
|- Healt Condition(s) or Problem(s) studied||Anxiety disorders|
|- Inclusion criteria||- Male or female volunteers between 18 and 40 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||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
- Have a 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 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 respiratory disease or history of respiratory disease.
- Current asthma or history of asthma.
- Acute cardiac disease and/or history of cardiac disease.
￼￼￼- ￼ History of abuse or current regular use of cannabis more than once a week.
- ￼ Have been using psychoactive drugs in the four weeks prior to the study.
- ￼￼￼Known hypersensitivity to CBD.
- Exposed to cannabinoids with adverse reactions.
- Have a history of severe allergy or general drug hypersensitivity.
￼￼￼- ￼ Current drug use or indications, from urine screening, of current drug use.
-￼ History of epilepsy.
￼￼￼- Reduced startle activity, defined as no discernible response in at least 3 startle stimuli presented at screening.
- Pregnancy, i.e., a positive β-HCG urine test.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2015|
|- planned closingdate||31-dec-2015|
|- Target number of participants||48|
|- Interventions||Cannabidiol (synthetic) in ethanol solution, inhaled via a vaporizer|
|- 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||Questionnaires, skin conductance responses. |
|- Timepoints||fear acquisition, fear expression, fear extinction, fear retention, reinstatement|
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||Dr. Ivo Heitland|
|- 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||30-jun-2015 - 18-okt-2015|