None listed
Conditions
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.
Interventions
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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with a primary diagnosis of social phobia.
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.
Outcome results
None listed