NCT05889741 Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
| NCT ID | NCT05889741 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Stress Disorders, Post-Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2024-02-26 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.
Eligibility Criteria
Inclusion Criteria: 1. Active duty and retired military service members ages 18-65 years 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale 3. Able to speak and read English (due to standardization of outcome measures) 4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed. Exclusion Criteria: 1. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider. 2. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment) 3. Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment. 4. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment 5. Pregnancy or breastfeeding 6. Current anticoagulant use 7. History of bleeding disorder 8. Infection or mass at injection site 9. Myocardial infarction within 6 months of procedure 10. Pathologic bradycardia or irregularities of heart rate or rhythm 11. Symptomatic hypotension 12. Phrenic or laryngeal nerve palsy 13. History of glaucoma 14. Uncontrolled seizure disorder 15. History of allergy to local anesthetics 16. Current use of Class III antiarrhythmics
Contact & Investigator
Alan Peterson, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT05889741 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Stress Disorders, Post-Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05889741 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05889741 currently recruiting?
Yes, NCT05889741 is actively recruiting participants. Contact the research team at floresa13@uthscsa.edu for enrollment information.
Where is the NCT05889741 trial being conducted?
This trial is being conducted at Fort Hood, United States, San Antonio, United States.
Who is sponsoring the NCT05889741 clinical trial?
NCT05889741 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Alan Peterson, PhD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 140 participants.