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The effect of cannabidiol in facilitating fear extinction and in attenuating fear retention and reinstatement in humans

The effect of cannabidiol in facilitating fear extinction and in attenuating fear retention and reinstatement in humans - The effect of cannabidiol (300 mg) on fear conditioning

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46397
Enrollment
56
Registered
2018-03-14
Start date
2018-04-09
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anxiety disorders pathological fear

Interventions

The primary intervention consists of one oral intake of a capsule with 300 mg cannabidiol or placebo.

Sponsors

Universiteit Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 *-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.

Design outcomes

Primary

MeasureTime frame
Fear as reflected in the EMG and SCR amplitude and as reflected in answers on a VAS during a passive VR navigation task (see protocol [C1] for details).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)