Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001504101
Ethics application status
Approved
Date submitted
16/10/2019
Date registered
31/10/2019
Date last updated
31/10/2019
Date data sharing statement initially provided
31/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of ketamine in phobic participants using virtual reality stimuli
Scientific title
Pilot study of ketamine in phobic participants using virtual reality stimuli
Secondary ID [1] 299548 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spider phobia 314809 0
Condition category
Condition code
Mental Health 313148 313148 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315801 0
Treatment: Drugs
Comparator / control treatment
0.05mg/kg of midazolam will be used as the psychoactive control. The order of dosing will be determined using computer-generated random code, using a balanced randomization.
Control group
Active

Outcomes
Primary outcome [1] 321695 0
Change in anxiety ratings
Timepoint [1] 321695 0
After each virtual reality headset spider presentation (which occurs 60 minutes post dose using 5 exposure levels of approximately 2 minutes each) plus 30 minutes post dose - measured by Fear Questionnaire item 18, visual analog scale of anxiety intensity(0mm = no anxiety, 100mm = most anxiety ever), Heart rate and Galvanic skin response measured using an E4 wristband. The E4 wristband is a wearable wireless device which measures galvanic skin response i.e. measures changes in the electrical resistance of the skin caused by emotional stress.
Secondary outcome [1] 375925 0
Completion of Fear Questionnaire item 18 phobic avoidance.
Timepoint [1] 375925 0
Predose and 30 minutes postdose plus after the virtual reality headset spider presentations which occur after 60 minutes.
Secondary outcome [2] 375926 0
How many of the 5 exposure levels using the virtual reality headset participants are able to complete.
Assessed by clinical observations of anxiety - recording heart rate and galvanic skin response. PLus participants will use 100 mm visual analog scale to self rate their anxiety intensity.
Timepoint [2] 375926 0
One hour after dosing participants will be exposed to images of spiders for approximately 2 minutes at a time using a virtual reality headset.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prof Glue will create the random codes. All study personnel involved with recruitment, dosing, data collection and analysis will have no access to the random codes until the databases are locked.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random code, using a balanced randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/11/2019
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
27/03/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 21925 0
New Zealand
State/province [1] 21925 0
Otago

Funding & Sponsors
Funding source category [1] 304035 0
University
Name [1] 304035 0
University of Otago
Country [1] 304035 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Po Box 56
Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 304225 0
None
Name [1] 304225 0
n/a
Address [1] 304225 0
n/a
Country [1] 304225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304526 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 304526 0
Ministry of Health
PO Box 5013
Wellington 6011
Ethics committee country [1] 304526 0
New Zealand
Date submitted for ethics approval [1] 304526 0
23/09/2019
Approval date [1] 304526 0
08/10/2019
Ethics approval number [1] 304526 0
19/STH/174

Summary
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.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 97266 0
Prof Paul Glue
Address 97266 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 97266 0
New Zealand
Phone 97266 0
+64 3 470 9451
Fax 97266 0
Email 97266 0
paul.glue@otago.ac.nz
Contact person for public queries
Name 97267 0
Dr Shona Neehoff
Address 97267 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 97267 0
New Zealand
Phone 97267 0
+64 3 470 9451
Fax 97267 0
Email 97267 0
shona.neehoff@otago.ac.nz
Contact person for scientific queries
Name 97268 0
Prof Paul Glue
Address 97268 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 97268 0
New Zealand
Phone 97268 0
+64 3 470 9451
Fax 97268 0
Email 97268 0
paul.glue@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.