The properties of CBD, namely potential effects on variables pertaining to fear extinction and potentially on fear retention/reinstatement while having non of the problematic side-effects found in *9-THC, make CBD plausibly preferential over *9-THC…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
NA
Background summary
A sizable number of patients do not respond optimally to standard treatment,
necessitating research for other potential therapeutic approaches to treating
anxiety disorders. One such alternative may be targeting the cannabinoid
system. Indeed, the endocannabinoid system has gained attention for its
involvement in the regulation of fear and memory.
Previous studies have shown that *9-THC induces anxiolytic effects. However,
the effect is dose dependent and results from our research group suggest that
effects of *9-THC may not extend beyond acute symptom-attenuating effects. One
other main constituent of cannabis, is cannabidiol which also affects the
endocannabinoid system. Although the evidence is still rather scarce, one
isolated study suggests that cannabidiol (CBD) may consolidate fear extinction
in human subjects, and a similar study using an inhalation method shows
positive effects of CBD on extinguishing fear over a longer time period. The
drawback of these studies was the aversiveness of the inhalation, therefor in
this study we will use capsules with CBD. This could have substantial
implications for the treatment of anxiety related psychopathology.
Study objective
The properties of CBD, namely potential effects on variables pertaining to fear
extinction and potentially on fear retention/reinstatement while having non of
the problematic side-effects found in *9-THC, make CBD plausibly preferential
over *9-THC (or preferential to a combination of *9-THC with CBD) in enhancing
fear extinction and reducing fear retention/reinstatement. Indeed, if so, CBD
may be an ideal candidate to aid exposure based treatment for anxiety
disorders. The specific objective in the current study is to assess the effect
of CBD in facilitating fear extinction and attenuating fear retention and
reinstatement as contrasted to placebo in a sample of healthy participants.
Parameters pertaining to fear will be assessed by both subjective
(questionnaires) as well as objective (electrophysiological) measures (EMG,
SCR).
Study design
This study follows a between subjects, double blind, randomized, placebo
controlled design.
Intervention
The primary intervention consists of one oral intake of a capsule with 300 mg
cannabidiol or placebo.
Study burden and risks
The burden and risk involved in participating in this study is negligible to
our opinion. Side-effects of CBD are minimal and CBD is well tolerated. The
intensity of the electric schocks is determined on an individual level, and is
well tolerated. Participation is voluntary, and participants can withdraw from
the study at any time, this will be clearly explained to participants.
Heidelberglaan 1
Utrecht 3584CS
NL
Heidelberglaan 1
Utrecht 3584CS
NL
Listed location countries
Age
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 *-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
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2017-003992-79-NL |
| CCMO | NL63520.041.17 |
| Other | NTR28295 |