Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

Part of paid clinical trials in Fort Hood, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05889741
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ropivacaine injection — DRUG
    6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
  • Normal saline — DRUG
    6.5cc of Normal Saline one time into the stellate ganglion.

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stellate Ganglion Block
    One time administration of a stellate ganglion block
  • Placebo Comparator: Sham SGB
    One time administration

Primary Outcome Measure

Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5) [ Time Frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Carl R. Darnall Army Medical CenterFort HoodTexas76544
Paul Fowler
[email protected]
726-225-5520
Caleb Dickinson, DO (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Amanda Flores
[email protected]
210-562-6726
Alan Peterson, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Hood, TX

By research site
Carl R. Darnall Army Medical Center· Fort Hood, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

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