No registrations found.
ID
Source
Health condition
anxiety disorders
Sponsors and support
Intervention
Outcome measures
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.
Study objective
The objective is to investigate the effect of cannabidiol (synthetic) as compared to placebo in facilitating fear extinction and reducing fear retention and reinstatement.
Study design
fear acquisition, fear expression, fear extinction, fear retention, reinstatement
Intervention
Cannabidiol (synthetic) in ethanol solution, inhaled via a vaporizer
Ivo Heitland
Heidelberglaan 1
Utrecht 3584CS
The Netherlands
+31302534582
i.heitland@uu.nl,
Ivo Heitland
Heidelberglaan 1
Utrecht 3584CS
The Netherlands
+31302534582
i.heitland@uu.nl,
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.
- Lactating.

Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5037 |
NTR-old | NTR5266 |
Other | NL49138.041.14 : METC |