Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000361909p
Ethics application status
Not yet submitted
Date submitted
5/03/2020
Date registered
13/03/2020
Date last updated
13/03/2020
Date data sharing statement initially provided
13/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Ketamine and spider phobia replication study
Scientific title
Replication study of ketamine in phobic participants using virtual reality stimuli
Secondary ID [1] 300719 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record
This replication study is a follow up to ACTRN12619001504101 with changes to the dosing regimen and additional outcome measure.

Health condition
Health condition(s) or problem(s) studied:
spider phobia 316540 0
Condition category
Condition code
Mental Health 314781 314781 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317041 0
Treatment: Drugs
Comparator / control treatment
0.02 mg/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 randomisation.
Control group
Active

Outcomes
Primary outcome [1] 323138 0
change in anxiety ratings
Fear Questionnaire Item 18
100 mm Visual Analogue Scale
Heart rate
Timepoint [1] 323138 0
-30 mins post dose FQ item 18, VAS, HR;
-60 mins FQ item 18, VAS, HR.
After the VR spider presentation ( 60 mins post-dose using 5 exposure levels);
Secondary outcome [1] 380942 0
Completion of Fear Questionnaire (FQ) item 18 - phobic avoidance

We are assessing the level of phobic avoidance by asking participants to complete Item 18 of the FQ.
Timepoint [1] 380942 0
predose
30 mins post dose
60 mins post dose
Secondary outcome [2] 380943 0
How many of the 5 exposure levels to spiders using VR participants are able to complete

This outcome is assessed by study personnel who can see on the dual monitor how many levels of the simulation the participants complete - and how long they remain at each level.
Timepoint [2] 380943 0
60 mins post dose

Eligibility
Key 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.
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 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 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. Study personnel involved with recruitment, dosing, data collection and analysis will not have 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
6/04/2020
Actual
Date of last participant enrolment
Anticipated
9/11/2020
Actual
Date of last data collection
Anticipated
7/12/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 22421 0
New Zealand
State/province [1] 22421 0
Otago

Funding & Sponsors
Funding source category [1] 305163 0
University
Name [1] 305163 0
University of Otago
Country [1] 305163 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56 Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 305526 0
None
Name [1] 305526 0
N/A
Address [1] 305526 0
N/A
Country [1] 305526 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305530 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 305530 0
Ministry of Health
PO bOx 5013
Wellington 6011
Ethics committee country [1] 305530 0
New Zealand
Date submitted for ethics approval [1] 305530 0
23/03/2020
Approval date [1] 305530 0
Ethics approval number [1] 305530 0

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 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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
This study is a replication study of ACTRN12619001504101.. The primary differences are
1. There are 2 dose periods instead of 3
2. We have added in resting EEG predose, at 60 mins during the VR presentation, at 70 mins and 48-72 hours post dose.

Contacts
Principal investigator
Name 100686 0
Prof Paul Glue
Address 100686 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 100686 0
New Zealand
Phone 100686 0
+64 3 470 9451
Fax 100686 0
Email 100686 0
[email protected]
Contact person for public queries
Name 100687 0
Dr Shona Neehoff
Address 100687 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 100687 0
New Zealand
Phone 100687 0
+64 3 470 9451
Fax 100687 0
Email 100687 0
[email protected]
Contact person for scientific queries
Name 100688 0
Prof Paul Glue
Address 100688 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 100688 0
New Zealand
Phone 100688 0
+64 3 470 9451
Fax 100688 0
Email 100688 0
[email protected]

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.