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 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. Changes in anxiety and phobia ratings, heart rate and skin response will be obtained pre-dose and immediately after each VR spider exposure.
Interventions
Participants with DSM V specific spider phobia will receive one of 3 randomized study treatments at weekly intervals - over a period of 3 weeks. Participants will be administered single oral doses of 0.5 mg/kg ketamine, 1.5mg/kg ketamine, 0.05mg/kg of midazolam (the psychoactive control) liquid added to 50 mls of orange juice. The order of the doses are randomized.
One hour after dosing the participants will be exposed to images of spiders using a virtual reality headset. We are using commercia
Participants with DSM V specific spider phobia will receive one of 3 randomized study treatments at weekly intervals - over a period of 3 weeks. Participants will be administered single oral doses of 0.5 mg/kg ketamine, 1.5mg/kg ketamine, 0.05mg/kg of midazolam (the psychoactive control) liquid added to 50 mls of orange juice. The order of the doses are randomized. One hour after dosing the participants will be exposed to images of spiders using a virtual reality headset. We are using commercially-available spider exposure software (https://store.steampowered.com/app/485270/Arachnophobia/), which has 5 levels. Lower levels have fewer spiders, and these are contained in a glass jar. Higher levels have more spiders, more movement, and are uncontained. Progression from lower to higher levels is under control of the participant, who can stop the simulation at any time. We will monitor ratings of anxiety using a 100 mm Visual Analog Scale (0mm= no anxiety; 100mm = worst anxiety ever), and physiological measures of anxiety including heart rate and galvanic skin response. Galvanic skin response is measured using an E4 wristband which is a wearable wireless device, galvanic skin response is changes in the electrical resistance of the skin caused by emotional stress. Participants will also complete the Fear Questionnaire item 18 - which measures level of phobic avoidance.
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 or over on the day of consent 3.Must meet criteria for DSM 5 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 who 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. 3. Any participant, for whom the investigator believes, for any reason, that participation would not be an acceptable risk 4..Current MDE, past or current bipolar disorder, schizophrenia. Participants with current anxiety disorders may be eligible. Use of antidepressants or other anxiolytics at stable doses >4 weeks is acceptable. 5.Participants with severe acute or chronic medical illnesses. 6. Participants with current active suicidal ideation.
Outcome results
None listed