Clinical TrialAnxiety DisordersKetamineMidalozamNot yet recruiting

Replication study of ketamine in phobic participants using virtual reality stimuli

This randomised controlled parallel group Phase II trial (n=12) evaluated the safety and efficacy of ketamine for spider phobia using 105mg/70kg ketamine.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

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.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine
  • Midalozam

Participants

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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment12 participants
  • Timeline
    Start: 2020-04-06
    End: 2020-11-09
  • Compounds
    KetamineMidalozam
  • Topic
    Anxiety Disorders

Locations

Unknown facility — Australia

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