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The effect of cannabidiol (40mg) on fear conditioning


- candidate number22397
- NTR NumberNTR5266
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jun-2015
- Secondary IDsMETC NL49138.041.14
- Public TitleThe effect of cannabidiol (40mg) on fear conditioning
- Scientific TitleThe effect of cannabidiol in facilitating fear extinction and in attenuating fear retention and reinstatement
- ACRONYM
- hypothesisThe 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) studiedAnxiety 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 criteriaA 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.
- Lactating.

- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate31-dec-2015
- Target number of participants48
- InterventionsCannabidiol (synthetic) in ethanol solution, inhaled via a vaporizer
- 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 outcomeQuestionnaires, skin conductance responses.
- Timepointsfear acquisition, fear expression, fear extinction, fear retention, reinstatement
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Ivo Heitland
- CONTACT for SCIENTIFIC QUERIESDr. Joke Baas
- Sponsor/Initiator Utrecht University (UU)
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-jun-2015 - 18-okt-2015


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