RECRUITING

Combining Esketamine and Prolonged Exposure Treatment for PTSD (Post Traumatic Stress Disorder)

Conditions

Post Traumatic Stress Disorder PTSD Massed Prolonged Exposure Esketamine

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to see if Prolonged Exposure (PE), a well-researched, very effective individual (one-to-one) behavioral therapy designed to help people to directly deal with traumatic events they have suffered in the past, can be combined with intranasal esketamine (ketamine) for the treatment of posttraumatic stress disorder (PTSD) to enhance treatment benefits. Ketamine nasal spray is a drug approved by the U.S. Food \& Drug Administration (FDA) for treatment resistant depression. Combined with PE, intranasal ketamine may help to augment PE and further reduce participants' PTSD symptoms.

Official Title

Combining Esketamine and Prolonged Exposure for PTSD: A Proof-of-Concept Clinical Trial

Quick Facts

Study Start:2025-06-09

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06795659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Individual between the ages of 18-65 years old (Young adults \[18 to 24 years old\] must not be taking an antidepressant). 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5) 3. Able to speak and read English (due to standardization of outcome measures) 4. On stable doses of current medications for at least 4 weeks 5. Weigh between 50-100 kg (110-220 pounds).	1. Young adults (18-24) currently taking any antidepressant. 2. Lifetime history of psychotic disorder or history of significant psychotic symptoms. 3. Lifetime history of manic episode. 4. Moderate or greater severity for alcohol or substance use disorder (DSM-5) in the previous six months. 5. A history of ketamine or phencyclidine abuse. 6. Evidence of a traumatic brain injury severe enough to interfere with comprehension and responding to the baseline screening questionnaires. 7. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider) 8. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment. 9. Current use (with past 4 weeks) of any prohibited concomitant medications 10. Benzodiazepines, other medications, sedatives, acute alcohol use, or recreational drug use that would put patients at risk in the judgment of clinical providers). 11. Planned use of ketamine (i.e., for pain control) or participation in another trauma-focused psychotherapy during the time of the study. 12. Uncontrolled hypertension or tachycardia 13. A history of sensitivity or adverse reaction to ketamine or its excipients 14. An unstable medical, cardiovascular, pulmonary, or neurological condition that the investigator considers a contraindication to ketamine administration 15. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. 16. Intracerebral hemorrhage. 17. Pregnancy or breastfeeding; women of childbearing potential unwilling to utilize reliable methods of contraception 18. History of nasal surgery or nasal obstructions experienced as an adult. 19. Inability to arrange for assisted transportation on ketamine treatment days due to recommendation that patient not drive for the remainder of the day following a ketamine treatment.

Inclusion Criteria

Exclusion Criteria

1. Individual between the ages of 18-65 years old (Young adults \[18 to 24 years old\] must not be taking an antidepressant).
2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
3. Able to speak and read English (due to standardization of outcome measures)
4. On stable doses of current medications for at least 4 weeks
5. Weigh between 50-100 kg (110-220 pounds).

1. Young adults (18-24) currently taking any antidepressant.
2. Lifetime history of psychotic disorder or history of significant psychotic symptoms.
3. Lifetime history of manic episode.
4. Moderate or greater severity for alcohol or substance use disorder (DSM-5) in the previous six months.
5. A history of ketamine or phencyclidine abuse.
6. Evidence of a traumatic brain injury severe enough to interfere with comprehension and responding to the baseline screening questionnaires.
7. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider)
8. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment.
9. Current use (with past 4 weeks) of any prohibited concomitant medications
10. Benzodiazepines, other medications, sedatives, acute alcohol use, or recreational drug use that would put patients at risk in the judgment of clinical providers).
11. Planned use of ketamine (i.e., for pain control) or participation in another trauma-focused psychotherapy during the time of the study.
12. Uncontrolled hypertension or tachycardia
13. A history of sensitivity or adverse reaction to ketamine or its excipients
14. An unstable medical, cardiovascular, pulmonary, or neurological condition that the investigator considers a contraindication to ketamine administration
15. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation.
16. Intracerebral hemorrhage.
17. Pregnancy or breastfeeding; women of childbearing potential unwilling to utilize reliable methods of contraception
18. History of nasal surgery or nasal obstructions experienced as an adult.
19. Inability to arrange for assisted transportation on ketamine treatment days due to recommendation that patient not drive for the remainder of the day following a ketamine treatment.

Contacts and Locations

Study Contact

Casey Straud, PsyD

CONTACT

210-562-6742

straud@uthscsa.edu

Principal Investigator

Casey Straud, PsyD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Casey Straud, PsyD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2025-06-09

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

Massed Prolonged Exposure
Esketamine

Additional Relevant MeSH Terms

Post Traumatic Stress Disorder PTSD