Stress Disorders, Post-TraumaticPhase 2NCT05889741
Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
A Phase 2 study testing Ropivacaine injection and Normal saline in people with Stress Disorders, Post-Traumatic, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Ropivacaine injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2024to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active duty and retired military service members ages 18-65 years
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
- Able to speak and read English (due to standardization of outcome measures)
- Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.
Who cannot join
- 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.
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
- Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
- Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
- Pregnancy or breastfeeding
- Current anticoagulant use
Show all 16Show fewer
- History of bleeding disorder
- Infection or mass at injection site
- Myocardial infarction within 6 months of procedure
- Pathologic bradycardia or irregularities of heart rate or rhythm
- Symptomatic hypotension
- Phrenic or laryngeal nerve palsy
- History of glaucoma
- Uncontrolled seizure disorder
- History of allergy to local anesthetics
- Current use of Class III antiarrhythmics
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
Paul Fowler, 726-225-5520, fowlerp@uthscsa.edu
Caleb Dickinson, DO
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Amanda Flores, 210-562-6726, floresa13@uthscsa.edu
Alan Peterson, PhD
About this study
Official title: Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- Ropivacaine injection, Normal saline
- Keywords
- SGB, Military
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Also called Naropin
6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
Normal salineDrug
6.5cc of Normal Saline one time into the stellate ganglion.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block | Experimental | One time administration of a stellate ganglion block Receives: Drug: Ropivacaine injection |
| Sham SGB | Placebo comparator | One time administration Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)
A 30-item structured interview used to assess change symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. Total severity scores range from 0 to 80 with higher score indicative of greater PTSD severity. The measure can also be used to confirm the presence of a PTSD diagnosis.
Measured: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)
A 20-item self-report measure that assesses the presence and change in severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). Total severity scores range from 0 to 80 with higher score indictive of greater PTSD severity.
Measured: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Secondary outcomes (10)
Patient Health Questionnaire-9 items (PHQ-9)
A 9-item self-report measure that assesses the presence and change in severity of depressive symptoms. Total scores range from 0 to 27 with higher scores reflective of greater severity.
Measured: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
General Anxiety Disorder Screener - 7 Items (GAD-7)
A 9-item self-report measure that assesses the presence and change in severity of general anxiety symptoms. Total scores range from 0 to 21 with higher scores reflective of greater severity.
Measured: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Posttraumatic Cognitions Inventory (PTCI)
A 36-item self-report measure that assesses change in self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure. Total scores range from 33 to 231 with higher scores reflective of more problematic cognitions.
Measured: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Psychophysiological arousal - Galvanic Skin Response
Change in Psychophysiological data collected from a smart watch measuring galvanic skin response
Measured: Two weeks
Psychophysiological arousal - Skin Temperature
Change in Psychophysiological data collected from a smart watch measuring skin temperature
Measured: Two weeks
Psychophysiological arousal - Heart Rate
Change in Psychophysiological data collected from a smart watch measuring heart rate
Measured: Two weeks
Psychophysiological arousal - Interbeat Interval
Change in Psychophysiological data collected from a smart watch measuring interbeat interval
Measured: Two weeks
Psychophysiological arousal - Three-Dimensional Accelerometer Movement
Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement
Measured: Two weeks
Psychophysiological arousal - Electrodermal Activity
Change in Psychophysiological data collected from a smart watch measuring electrodermal activity
Measured: Two weeks
Psychophysiological arousal - Photoplethysmography
Change in Psychophysiological data collected from a smart watch measuring photoplethysmography
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start26 Feb 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Alan Peterson, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889741
- Sponsor's protocol ID
- HSC20230087H
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29362795Hanling 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.
PubMed 27187898Lipov 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.
PubMed 19034755Lynch 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.
PubMed 27612365Mulvaney 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.
PubMed 25269132Odosso 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.
PubMed 33242072Peterson 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.
PubMed 36602803
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05889741
- Acronym / sponsor ID
- HSC20230087H
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- SGB, Military
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block | Experimental | Drug: Ropivacaine injectionOne time administration of a stellate ganglion block |
| Sham SGB | Placebo comparator | Drug: Normal salineOne time administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active duty and retired military service members ages 18-65 years
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
- Able to speak and read English (due to standardization of outcome measures)
- Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.
Key exclusion criteria (16 listed)
- 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.
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
- Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
- Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine injectionAlso: Naropin6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion | Drug | Stellate Ganglion Block |
| Normal saline6.5cc of Normal Saline one time into the stellate ganglion. | Drug | Sham SGB |
Primary outcome
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
A 30-item structured interview used to assess change symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. Total severity scores range from 0 to 80 with higher score indicative of greater PTSD severity. The measure can also be used to confirm the presence of a PTSD diagnosis.
Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 20-item self-report measure that assesses the presence and change in severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). Total severity scores range from 0 to 80 with higher score indictive of greater PTSD severity.
10 secondary outcomes
Patient Health Questionnaire-9 items (PHQ-9)
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
General Anxiety Disorder Screener - 7 Items (GAD-7)
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Posttraumatic Cognitions Inventory (PTCI)
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Psychophysiological arousal - Galvanic Skin Response
Time frame: Two weeks
Psychophysiological arousal - Skin Temperature
Time frame: Two weeks
Psychophysiological arousal - Heart Rate
Time frame: Two weeks
Psychophysiological arousal - Interbeat Interval
Time frame: Two weeks
Psychophysiological arousal - Three-Dimensional Accelerometer Movement
Time frame: Two weeks
Psychophysiological arousal - Electrodermal Activity
Time frame: Two weeks
Psychophysiological arousal - Photoplethysmography
Time frame: Two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 29362795Foa 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.
- Background: PubMed 27187898Hanling 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.
- Background: PubMed 19034755Lipov 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.
- Background: PubMed 27612365Lynch 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.
- Background: PubMed 25269132Mulvaney 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.
- Background: PubMed 33242072Odosso 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.
- Background: PubMed 36602803Peterson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Peterson, PhD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine injection and Normal saline in people with Stress Disorders, Post-Traumatic, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Flores (210-562-6726, floresa13@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05889741, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.