Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

NCT ID: NCT05889741

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2027-08-31

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.

Detailed Description

Massed PE will be conducted by master-level or doctoral-level therapists. Participants will meet with their providers for individual, 90-minute sessions. They will then be asked to complete out-of-session treatment assignments throughout the rest of the day. Between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, Monday through Friday, for two weeks. Each participant will also be offered three booster sessions at 1-, 3-, and 7-weeks posttreatment.

The stellate ganglion block injection or the sham SGB will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration.

Assessments will be administered at pretreatment, during treatment, at posttreatment, and at 1-, 3-, and 6-months following the completion of PE. The primary outcome assessment will be 1-month following the completion of PE. Following this assessment, participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Stellate Ganglion Block

One time administration of a stellate ganglion block

Group Type: EXPERIMENTAL

Ropivacaine injection

Intervention Type: DRUG

6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion

Sham SGB

One time administration

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

6.5cc of Normal Saline one time into the stellate ganglion.

Interventions

Ropivacaine injection

6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion

Intervention Type: DRUG

Normal saline

6.5cc of Normal Saline one time into the stellate ganglion.

Intervention Type: DRUG

Other Intervention Names

Naropin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Peterson, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

Carl R. Darnall Army Medical Center

Fort Hood, Texas, United States

Site Status: RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amanda Flores

Role: CONTACT

floresa13@uthscsa.edu

210-562-6726

Facility Contacts

Paul Fowler

Role: primary

fowlerp@uthscsa.edu

726-225-5520

Amanda Flores

Role: primary

floresa13@uthscsa.edu

210-562-6726

References

Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.

Reference Type: BACKGROUND

PMID: 29362795 (View on PubMed)

Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, McLay RN. Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):494-500. doi: 10.1097/AAP.0000000000000402.

Reference Type: BACKGROUND

PMID: 27187898 (View on PubMed)

Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available.

Reference Type: BACKGROUND

PMID: 19034755 (View on PubMed)

Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518.

Reference Type: BACKGROUND

PMID: 27612365 (View on PubMed)

Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151.

Reference Type: BACKGROUND

PMID: 25269132 (View on PubMed)

Odosso RJ, Petta L. The Efficacy of the Stellate Ganglion Block as a Treatment Modality for Posttraumatic Stress Disorder Among Active Duty Combat Veterans: A Pilot Program Evaluation. Mil Med. 2021 Jul 1;186(7-8):e796-e803. doi: 10.1093/milmed/usaa246.

Reference Type: BACKGROUND

PMID: 33242072 (View on PubMed)

Peterson AL, Blount TH, Foa EB, Brown LA, McLean CP, Mintz J, Schobitz RP, DeBeer BR, Mignogna J, Fina BA, Evans WR, Synett S, Hall-Clark BN, Rentz TO, Schrader C, Yarvis JS, Dondanville KA, Hansen H, Jacoby VM, Lara-Ruiz J, Straud CL, Hale WJ, Shah D, Koch LM, Gerwell KM, Young-McCaughan S, Litz BT, Meyer EC, Blankenship AE, Williamson DE, Roache JD, Javors MA, Sharrieff AM, Niles BL, Keane TM; Consortium to Alleviate PTSD. Massed vs Intensive Outpatient Prolonged Exposure for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2249422. doi: 10.1001/jamanetworkopen.2022.49422.

Reference Type: BACKGROUND

PMID: 36602803 (View on PubMed)

Other Identifiers

HSC20230087H

Identifier Type: -

Identifier Source: org_study_id