Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000363583
Ethics application status
Approved
Date submitted
16/08/2006
Date registered
21/08/2006
Date last updated
21/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of Temgesic in combination with exposure therapy to treat social anxiety symptoms.
Scientific title
A randomised controlled trial to evaluate the effect of Temgesic (0.2mg) in combination with exposure therapy for the treatment of social phobia to improve the severity of social phobia symptoms.
Secondary ID [1] 299 0
Human Research Ethics Committee (HREC): HREC05240
Secondary ID [2] 300 0
Clinical Trial Notification (CTN): CTN 2005/605
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Phobia 1332 0
Condition category
Condition code
Mental Health 1420 1420 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with social phobia are given group exposure based therapy over 5 weekly treatment sessions in combination with a sublingual dose of Temgesic (0.2mg) or placebo. Exposure therapy consists of 3 to 10 minute speech tasks in front of a group where a decrease in anxiety within this situation is observed.
Intervention code [1] 1313 0
Treatment: Drugs
Comparator / control treatment
Participants with social phobia are given group exposure based therapy over 5 weekly treatment sessions in combination with placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 1941 0
Severity of Social Phobia Symptoms
Timepoint [1] 1941 0
Assessed one month post-treatment.
Secondary outcome [1] 3402 0
General functioning
Timepoint [1] 3402 0
Assessed at one-month follow-up.

Eligibility
Key inclusion criteria
Adults with a primary diagnosis of social phobia.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant liver and kidney impairment, imparied respiratory function, head injury, substance abuse and dependence. Participants must not drink alcohol, caffeine or grapefruit juice on the day of drug administration.

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)
Drug Allocation Concealmet is conducted by numbering all containers whereby each container is numbered
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using computer software. There is no stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1552 0
University
Name [1] 1552 0
University of New South Wales
Country [1] 1552 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 1365 0
None
Name [1] 1365 0
None
Address [1] 1365 0
Country [1] 1365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2982 0
University of New South Wales
Ethics committee address [1] 2982 0
Ethics committee country [1] 2982 0
Australia
Date submitted for ethics approval [1] 2982 0
Approval date [1] 2982 0
14/11/2005
Ethics approval number [1] 2982 0
HREC05240
Ethics committee name [2] 2983 0
NSW Health
Ethics committee address [2] 2983 0
Ethics committee country [2] 2983 0
Australia
Date submitted for ethics approval [2] 2983 0
Approval date [2] 2983 0
13/09/2005
Ethics approval number [2] 2983 0

Summary
Brief summary
This study tests whether Temgesic improves the effectiveness of exposure therapy for decreasing social anxiety symptoms. We predict that individuals from the community diagnosed with social phobia who receive four exposure therapy sessions in combination with Temgesic will experience a greater reduction in social anxiety symptoms in comparison to individuals who received the placebo in combination with four exposure therapy sessions. Participants receive, in total, five weekly group therapy sessions, the first is educational and the next four consist of public speaking exposure therapy. One month post intervention participants are assessed for social anxiety symptoms as well as other general health indicators. All subjects, therapists, assessors, and data entry staff are blind to condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27920 0
Address 27920 0
Country 27920 0
Phone 27920 0
Fax 27920 0
Email 27920 0
Contact person for public queries
Name 10502 0
Dr Adam Guastella
Address 10502 0
School of Psychology
University of New South Wales
Kensington, 2052
Country 10502 0
Australia
Phone 10502 0
02 9385 8071
Fax 10502 0
Email 10502 0
[email protected]
Contact person for scientific queries
Name 1430 0
Dr Adam Guastella
Address 1430 0
School of Psychology
University of New South Wales
Kensington, 2052
Country 1430 0
Australia
Phone 1430 0
02 9385 8071
Fax 1430 0
Email 1430 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.