Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000353594
Ethics application status
Approved
Date submitted
28/07/2006
Date registered
16/08/2006
Date last updated
16/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Oxytocin on Extinction of fear in a Pavlovian Fear- Conditioning Procedure.
Scientific title
A randomised phase III trial to evaluate the effect of Oxyocin on non-clinical conditioned fear in a Pavlovian Fear-Conditioning Procedure to enhance extinction.
Secondary ID [1] 293 0
Human Research Ethics Committee (HREC): HREC06074
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Clinical Conditioned Fear 1323 0
Condition category
Condition code
Mental Health 1410 1410 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive 24 Intranasal Units (IU) of Oxytocin Nasal Spray 45 minuites before an Pavlovian extinction procedure whereby the conditioned stimulus is presented 4 times without the Unconditioned Stimulus (US; shock) over a 4 minute period.
Intervention code [1] 1233 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1931 0
Skin-Conductance Levels
Timepoint [1] 1931 0
Assessed the day after the extinction procedure.
Primary outcome [2] 1932 0
Expectency for shock
Timepoint [2] 1932 0
Assessed the day after the extinction procedure.
Secondary outcome [1] 3392 0
Skin-Conductance Levels and Expectency for shock to the reinforced and safe cue.
Timepoint [1] 3392 0
Assessed the day after extinction.

Eligibility
Key inclusion criteria
Adult university students.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) severe psychosis, depression, and anxiety didosrders, presence of severe medical illness, 2) smoking more than 15 cigarettes per day, 3) drug or alcohol abuse, 4) any possibility of pregnancy. Subjects are instructed to abstain from food and drink (other than water) for 2 h before the experiment, and from alcohol, smoking and caffeine, or any illegal frugs, for 24 h before the experiment.

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)
Allocation concealment was conducted by numbering drug capsule containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generarion using computer software to generate random allocation in blocks such that for the doses given, equal numbers of placebo and oxytocin are handed out
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All therapists, assessors, and data antry staff are blinded to drug condition.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1543 0
University
Name [1] 1543 0
University of New South Wales
Country [1] 1543 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 1356 0
None
Name [1] 1356 0
Nil
Address [1] 1356 0
Country [1] 1356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2973 0
University of New South Wales
Ethics committee address [1] 2973 0
Ethics committee country [1] 2973 0
Australia
Date submitted for ethics approval [1] 2973 0
Approval date [1] 2973 0
Ethics approval number [1] 2973 0
06074

Summary
Brief summary
The aim of this study is to evaluate whether Oxytocin facilitates extinction of conditioned fear. On day 1, participants 2 pictures are conditioned to the shock such that upon presentation of these pictures, participants respond with a fear response as indicated by skin conductance and expectancy measures. One picture is never paired with shock is a referred to as the safe cue. The next day (day 2) participants receive either OT or Placebo and return 45 minutes later. All three pictures are presented in the same way, except one of the pictures that was paird with shock originally is no longer paird with shock. This is called an extinction procedure. Participants then return the following day and are presented with the three pictures. We are assessing their fear response to the pictures with the hypothesis being that those who had the Oxytocin will respond with less of a fear response to the extinguished cue, as measured by skin conductance and expectancy measures, in comparison to those who received the placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35874 0
Address 35874 0
Country 35874 0
Phone 35874 0
Fax 35874 0
Email 35874 0
Contact person for public queries
Name 10422 0
Adam Guastella
Address 10422 0
School of Psychology
University of New South Wales
Kensignton NSW 2052
Country 10422 0
Australia
Phone 10422 0
+61 2 93858071
Fax 10422 0
Email 10422 0
[email protected]
Contact person for scientific queries
Name 1350 0
Adam Guastella
Address 1350 0
School of Psychology
University of New South Wales
Kensignton NSW 2052
Country 1350 0
Australia
Phone 1350 0
+61 2 93858071
Fax 1350 0
Email 1350 0
[email protected]

No information has been provided regarding IPD availability


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.