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Stellate Ganglion Block + Therapy for PTSD
Phase 2
Recruiting
Led By Alan Peterson, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 1-month, 3-month, and 6-month follow-up assessments
Summary
"This trial aims to see if combining Massed Prolonged Exposure therapy with a stellate ganglion block injection is more effective in treating PTSD in military service members compared to just the therapy with
Who is the study for?
This trial is for active duty and retired military service members aged 18-65 with PTSD, who can speak and read English. They must be eligible to receive care at a military treatment facility where the neck injection will take place.
What is being tested?
The study tests if adding a stellate ganglion block (a local anesthetic neck injection) to Massed Prolonged Exposure therapy improves PTSD outcomes compared to the same therapy with a sham injection.
What are the potential side effects?
Possible side effects from the Ropivacaine injection include soreness or bruising at the injection site, dizziness, nausea, or numbness. The saline sham may cause discomfort but no medicinal side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at 1-month, 3-month, and 6-month follow-up assessments
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 1-month, 3-month, and 6-month follow-up assessments
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)
Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)
Secondary study objectives
General Anxiety Disorder Screener - 7 Items (GAD-7)
Patient Health Questionnaire-9 items (PHQ-9)
Posttraumatic Cognitions Inventory (PTCI)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stellate Ganglion BlockExperimental Treatment1 Intervention
One time administration of a stellate ganglion block
Group II: Sham SGBPlacebo Group1 Intervention
One time administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine injection
2012
Completed Phase 4
~510
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,835 Total Patients Enrolled
United States Department of DefenseFED
910 Previous Clinical Trials
333,591 Total Patients Enrolled
Alan Peterson, PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
3 Previous Clinical Trials
812 Total Patients Enrolled
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