The effects of cannabidiol (CBD) on psychosocial stress, situational anxiety and nausea experienced in a virtual reality environment
A randomised, double-blind, placebo-controlled, parallel-group trial exploring the effect of purified oral cannabidiol (CBD) on psychosocial stress, situational anxiety, acute motion sickness and cybersickness experienced in a virtual reality environment in healthy individuals.
University of Sydney
74 participants
Oct 26, 2023
Interventional
Conditions
Summary
Preclinical studies and clinical trials involving cannabidiol (CBD) have suggested potential efficacy in treatment of psychosocial stress, situational anxiety, and nausea. This study is a randomised, double-blinded, single-dose experimental trial that use a series of customised virtual reality (VR) experiences to investigate the effects of purified, oral cannabidiol (CBD) on subjective, endocrine, and physiological markers of: (1) acute psychosocial stress during a simulated public speaking task, (2) situational anxiety when walking a narrow plank above a sheer drop, (3) acute motion sickness induced by a virtual reality rollercoaster ride and (4) cybersickness induced by exposure to VR in healthy individuals. Participants will complete one experimental sessions involving either (1) CBD or (2) Placebo. Trials will be conducted at the Brain and Mind Centre, Camperdown. We hypothesise that CBD will improve ratings of psychosocial stress, situational anxiety and nausea.
Eligibility
Inclusion Criteria4
- a) Healthy adults aged between 18-50 years.
- b) Proficient in English (able to provide informed consent).
- c) Residing in Greater Sydney NSW Australia.
- d) Willing to follow the protocol requirements.
Exclusion Criteria16
- a) Self-reported regular use (i.e., more than twice weekly) of any cannabis or cannabinoid-containing products including CBD in the past two weeks.
- b) Self-reported regular use (i.e., more than twice weekly) use of psychotropic drugs (licit or illicit) (e.g., cannabis, amphetamines, cocaine, ecstasy (MDMA), LSD (acid), antidepressants, opioids, benzodiazepines) within the past two weeks.
- c) Self-reported regular use (i.e., more than twice weekly) of medication that may affect the stress response (e.g., corticosteroids, beta-blockers) within the past two weeks
- d) Self-reported history of allergic reactions (e.g., urticaria or anaphylaxis) to cannabis or cannabis-based products.
- e) Self-reported history of liver disease, renal disease, epilepsy or heart disease (currently (i.e., within the past 2-weeks) controlled high blood pressure <140/90mmHg is acceptable)
- f) Current (i.e., within the past 2-weeks) otologic (vestibular) disease
- g) A history of repeated episodes of syncope
- h) Pregnant, lactating, or trying to conceive.
- i) Self-reported drug and/or alcohol dependence (or suspected drug and/or alcohol dependence as determined by the trial physician)
- j) A medically diagnosed anxiety disorder (e.g., social anxiety disorder) within the past 12 months
- k) Current suicide ideation (i.e., a score >0 on Question 9 of the Patient Health Questionnaire) or suspected suicide ideation as determined by the trial physician.
- l) Current depression, anxiety, and stress scores outside the healthy range of the Depression Anxiety Stress Scale-21 (> moderate on DASS-21 for depression, anxiety and stress).
- m) An uncontrolled chronic medical condition (mental or physical)
- n) Self-reported high vulnerability to cybersickness or motion sickness.
- o) Frequent (> weekly) use of VR technologies, which tends to produce desensitisation towards motion sickness.
- p) Self-reported intense fear of heights.
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Interventions
The intervention will be an acute dose of cannabidiol (CBD). Specifically, it will be 2 x soft-gel capsules of CBD (150mg total) in an oil-based formulation. The capsules will be consumed (once only) via oral ingestion under the supervision of an investigator 90-minutes prior to exposure to a series of three customised virtual reality (VR) experiences using the Vive Pro Eye VR headset including (1) a 15-minute simulated public speaking task, the "Public Speaking" task (2) a 5-minute task of walking a narrow virtual plank above a sheer drop, the "Walk the Plank" task; and (3) a 5-minute virtual reality rollercoaster ride, the "Rollercoaster Ride". Each VR task will be separated by a rest period of 10-minutes. Each participant will complete all three VR tasks after treatment (i.e., CBD or placebo) during individual "Test Days".
Locations(1)
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ACTRN12623000872639