None listed
Conditions
Brief summary
We hypothesise that Ketamine could be used therapeutically to manage phobic situations that interfere with health or business activities (e.g. needle phobic patients getting medical/dental procedures; aeroplane/flight phobic patients needing to travel by air). The purpose of the study is to evaluate the effect of oral doses of ketamine and the active control, midazolam, on anxiety ratings in participants with spider phobia. Images of spiders will be presented to participants at 60 minutes via a virtual reality (VR) headset. 5 spider encounters will be presented that vary in terms of size, activity level and proximity of the VR spider to the participant. Resting EEG will be recorded predose, during the VR spider simulation, and at 70 mins, after the spider simulation exercise is completed. Changes in anxiety and phobia ratings, plus heart rate will be obtained pre-dose, at 30 mins and immediately after each VR spider exposure at 60 mins.. This study is a replication study of ACTRN12619001504101.
Interventions
Participants with DSM 5 specific spider phobia will receive one of 2 randomized study treatments separated by one week. Participants will be administered single oral doses of 1.5 mg/kg ketamine and 0.02mg/kg midazolam (the psychoactive control) liquid added to 50mls orange juice. The order of the doses is randomized.
One hour after dosing participants will be exposed to images of spiders using a Virtual Reality
(VR) headset. We are using commercially available spider exposure software (https:/
Participants with DSM 5 specific spider phobia will receive one of 2 randomized study treatments separated by one week. Participants will be administered single oral doses of 1.5 mg/kg ketamine and 0.02mg/kg midazolam (the psychoactive control) liquid added to 50mls orange juice. The order of the doses is randomized. One hour after dosing participants will be exposed to images of spiders using a Virtual Reality (VR) headset. We are using commercially available spider exposure software (https://store.steampowered.com/app/485270/Arachnophobia/) which has 5 levels. Lower levels have less spiders, that are contained in a glass jar. Higher levels have more spiders, more movement, and they are uncontained. Progression from lower to higher levels is under control of the participant, who can stop the simulation at any time. Resting EEG will be recorded predose, during the VR simulation, at 70 minutes and 48-72 hours post dose. We will monitor ratings of anxiety using a 100mm Visual Analog Scale (0mm = no anxiety, 100mm = worst anxiety) and physiological measures of anxiety including heart rate. Participants will also complete the Fear Questionnaire (FQ) item 18 - which measures level of phobic avoidance. The maximum duration of vR stimulation per visit is up to 5 minutes.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.Capable of understanding and signing an informed consent 2.Aged >18 years on the day of consent. 3.Must meet criteria for DSM5 specific phobia, and have a Fear of Spiders Questionnaire score >95 to participate.
Exclusion criteria
1.Female participants who are or intend to become pregnant, or are lactating 2.Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved). 3.Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
Outcome results
None listed