PTSDPhase 2NCT05837845
MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
A Phase 2 study testing MDMA, Cognitive Processing Therapy and MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in people with PTSD, run by Patricia Suppes at 1 site in United States.
Trial summary
In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- MDMA, Cognitive Processing Therapy and MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Are at least 18 years at the time of signing the informed consent
- Are a U.S Military Veteran
- Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
- Are fluent in speaking and reading in English
- Agree to have study visits audio and/or video recorded
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- If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions
- Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months
- Have severe PTSD symptoms in the last month
- Body weight of at least 48 kilograms (kg)
- Is not pregnant, planning to get pregnant, or breastfeeding
- Capable of giving signed informed consent
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful
- Have current unstable medical illness
- Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
- Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
- Moderate or severe alcohol or cannabis use disorder within the last 12 months
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- Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months
- Have current serious suicide risk
- Unable or unwilling to stop or safely taper off prohibited medications
- Have used MDMA (ecstasy) ever
- Currently enrolled in any clinical study
- Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features
- Lack social support, or lack a stable living situation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Health Care System / Stanford University
Palo Alto, California, 94304
Anna Donnelly, 650-849-0161, anna.donnelly@va.gov
Trisha Suppes, MD, PhD
About this study
Official title: A Randomized Trial to Compare MDMA-assisted Cognitive Processing Therapy (aCPT) Versus a VA Standard-of-care CPT for the Treatment of Severe Posttraumatic Stress Disorder Among Veterans
In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-aCPT for PTSD within the VA system.
Read the detailed description
Posttraumatic stress disorder (PTSD) is a serious debilitating disorder that negatively impacts a person's daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance use disorders, high-cost healthcare utilization, increased depression, and suicide risk. People who suffer from PTSD relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. Symptoms can be severe and long lasting.
Many available PTSD treatments, including medications and therapy, effectively treat only a fraction of people who try them. This indicates a need to assess treatments targeting durable remission of PTSD. An extensive list of medications, namely antipsychotics, anxiolytics, antidepressants, and sleep aids, are frequently prescribed off-label but are minimally effective in reducing PTSD symptoms.
Cognitive Processing Therapy (CPT) is a cognitively-oriented approach to treating PTSD developed in the late 1980's by Dr. Patricia Resick. Significant research on CPT has been conducted in the VA system nationally. Across a number of studies, a meta-analysis found the number of subjects that no longer meet PTSD criteria after receiving a full course of CPT ranged from 30% to 97%, and 51% of subjects receiving CPT achieved loss of diagnosis compared to waitlist, self-help booklets, and treatment as usual control groups. There are various task forces and active efforts to deploy CPT more broadly in the VA.
MDMA-assisted cognitive processing therapy (MDMA-aCPT) is a novel treatment package that combines standard CPT with the administration of MDMA (3,4-methylenedioxymethamphetamine) during medication sessions separate from CPT sessions. This includes the regular course of 8-15 CPT sessions, three sessions during which MDMA is used, and an additional one 'preparatory' session and three 'integration' sessions without the use of medication. Data from a series of Phase 2 and Phase 3 studies of MDMA-assisted therapy provide preliminary evidence suggesting that chronic PTSD symptoms are improved by up to three sessions of MDMA-assisted therapy and associated non-drug preparatory and integrative therapy sessions.
Our goal is to learn how MDMA-aCPT compares to CPT in reducing PTSD symptoms among Veterans. Comparing MDMA-aCPT and CPT for the treatment of PTSD is particularly important due to the urgent need for effective treatments within the VA system.
PTSD carries a high public burden, both economically and socially, by increased healthcare utilization, use of social services, lost wages, and disability payments. Given the chronicity of PTSD, low treatment compliance evidenced by high dropouts, and limited recovery with current medications contributing to serious outcomes, PTSD patients exhibit an unmet medical need. Currently, the VA serves approximately nine million Veterans and the conservative estimate of those with PTSD is 25%, or over two million Veterans. The potential importance and benefits of this novel treatment to Veterans, doctors, researchers, and the VA system cannot be underestimated. The clinical effectiveness, implementation evaluation, and economic assessment conducted in this study will provide critical information and understanding of the feasibility of utilization in the VA system.
- Conditions
- PTSD
- Being tested
- MDMA, Cognitive Processing Therapy, MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)
- Keywords
- MDMA-assisted Therapy, Cognitive Processing Therapy, Veterans, Posttraumatic stress disorder, Quality of Life
- 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.
MDMADrug
Participants will receive a flexible divided-dose of MDMA HCl plus therapy at three Experimental Sessions, as well as non-drug Preparatory and Integration Sessions
Cognitive Processing TherapyBehavioural
Participants will receive 8-15 (average of 12) sessions of Cognitive Processing Therapy
MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)Behavioural
Participants assigned to MDMA-aCPT will undergo a therapeutic approach administered by trained therapists. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. MDMA can elicit feelings of empathy, love, and deep appreciation, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present. A combined treatment of MDMA and therapy may be especially useful for treating PTSD because MDMA can attenuate the fear response of a perceived threat to one's emotional integrity and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion.
| Study group | Role | What they receive |
|---|---|---|
| MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) | Experimental | This arm consists of 8-15 virtual CPT sessions (average of 12), one 90-minute, non-drug Preparatory Session, three Experimental Sessions with MDMA (~8 hours), and three 90-minute, non-drug Integration Sessions, occurring over a 9-15-week Treatment Period. Standardized homework is assigned at each CPT session to promote the practice of the skills taught in the session. Participants will receive 80mg MDMA HCl for the first Experimental Session and will have the option of a supplemental dose of 40mg MDMA HCI 1.5-2 hours after the initial dose. For the second and third Experimental Sessions, participants will receive either 80mg or 120mg MDMA HCl as the initial dose, and an optional supplemental dose of 40mg or 60mg MDMA HCl 1.5-2 hours after the initial dose. Participants interested in receiving CPT treatment alone after study completion will have the option to be referred to their local VA PTSD Clinical Team for services 6 months after all study visits are completed. Receives: Drug: MDMA; Behavioral: MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) |
| Cognitive processing therapy | Experimental | This arm consists of 8-15 virtual CPT treatment sessions lasting approximately 1-1.5 hours, occurring over a ~12-16-week Treatment Period. These sessions will take place approximately one week apart. Standardized homework is assigned at each session to promote the practice of the skills taught in the session. Participants will have the option to crossover to the MDMA-aCPT arm 6 months after all study visits are completed. Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score
The Primary Outcome measure will be the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Baseline to 4 months post-baseline assessed by a blinded study staff rater.
The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Measured: From Baseline to approximately 4 months post-baseline
Secondary outcomes (1)
Change in Quality of Life Enjoyment and Satisfaction Questionnaire
The secondary outcome measure will be the change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF).
The Q-LES-Q-SF is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The summary scores were found to be reliable and valid measures of these dimensions in a group of depressed outpatients. The Q-LES-Q-SF measures were related to, but not redundant with, measures of overall severity of illness or severity of depression within this sample. These findings suggest that the Q-LES-Q-SF measures may be sensitive to important differences among depressed patients that are not detected by the measures usually employed. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score ranges from 0-70, with higher scores indicating greater life satisfaction and enjoyment.
Measured: From Baseline to approximately 4 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start10 Feb 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Model description
- This is a randomized study. Participants will be 1:1 randomized to receive either MDMA-aCPT or CPT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patricia Suppes
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, VA Palo Alto Health Care System, Steven & Alexandra Cohen Foundation
- Responsible party
- Sponsor-investigator, Patricia Suppes, Palo Alto Veterans Institute for Research
- Investigators
- Trisha Suppes, MD, PhD, Principal investigator, VA Palo Alto Healthcare System / Stanford UniversityShannon Wiltsey Stirman, PhD, Principal investigator, VA Palo Alto Healthcare System / Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837845
- Sponsor's protocol ID
- SUP0023APR
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Compare MDMA-assisted Cognitive Processing Therapy (aCPT) Versus a VA Standard-of-care CPT for the Treatment of Severe Posttraumatic Stress Disorder Among Veterans
- ClinicalTrials.gov ID
- NCT05837845
- Acronym / sponsor ID
- SUP0023APR
- Conditions
- PTSD
- Keywords
- MDMA-assisted Therapy, Cognitive Processing Therapy, Veterans, Posttraumatic stress disorder, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Patricia SuppesUniversity, hospital or other
- Collaborators
- Stanford University, VA Palo Alto Health Care System, Steven & Alexandra Cohen Foundation
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 May 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.
In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-aCPT for PTSD within the VA system.
Detailed description
Posttraumatic stress disorder (PTSD) is a serious debilitating disorder that negatively impacts a person's daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance use disorders, high-cost healthcare utilization, increased depression, and suicide risk. People who suffer from PTSD relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. Symptoms can be severe and long lasting.
Many available PTSD treatments, including medications and therapy, effectively treat only a fraction of people who try them. This indicates a need to assess treatments targeting durable remission of PTSD. An extensive list of medications, namely antipsychotics, anxiolytics, antidepressants, and sleep aids, are frequently prescribed off-label but are minimally effective in reducing PTSD symptoms.
Cognitive Processing Therapy (CPT) is a cognitively-oriented approach to treating PTSD developed in the late 1980's by Dr. Patricia Resick. Significant research on CPT has been conducted in the VA system nationally. Across a number of studies, a meta-analysis found the number of subjects that no longer meet PTSD criteria after receiving a full course of CPT ranged from 30% to 97%, and 51% of subjects receiving CPT achieved loss of diagnosis compared to waitlist, self-help booklets, and treatment as usual control groups. There are various task forces and active efforts to deploy CPT more broadly in the VA.
MDMA-assisted cognitive processing therapy (MDMA-aCPT) is a novel treatment package that combines standard CPT with the administration of MDMA (3,4-methylenedioxymethamphetamine) during medication sessions separate from CPT sessions. This includes the regular course of 8-15 CPT sessions, three sessions during which MDMA is used, and an additional one 'preparatory' session and three 'integration' sessions without the use of medication. Data from a series of Phase 2 and Phase 3 studies of MDMA-assisted therapy provide preliminary evidence suggesting that chronic PTSD symptoms are improved by up to three sessions of MDMA-assisted therapy and associated non-drug preparatory and integrative therapy sessions.
Our goal is to learn how MDMA-aCPT compares to CPT in reducing PTSD symptoms among Veterans. Comparing MDMA-aCPT and CPT for the treatment of PTSD is particularly important due to the urgent need for effective treatments within the VA system.
PTSD carries a high public burden, both economically and socially, by increased healthcare utilization, use of social services, lost wages, and disability payments. Given the chronicity of PTSD, low treatment compliance evidenced by high dropouts, and limited recovery with current medications contributing to serious outcomes, PTSD patients exhibit an unmet medical need. Currently, the VA serves approximately nine million Veterans and the conservative estimate of those with PTSD is 25%, or over two million Veterans. The potential importance and benefits of this novel treatment to Veterans, doctors, researchers, and the VA system cannot be underestimated. The clinical effectiveness, implementation evaluation, and economic assessment conducted in this study will provide critical information and understanding of the feasibility of utilization in the VA system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized study. Participants will be 1:1 randomized to receive either MDMA-aCPT or CPT.
| Arm | Type | Receives |
|---|---|---|
| MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) | Experimental | Drug: MDMA, Behavioral: MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)This arm consists of 8-15 virtual CPT sessions (average of 12), one 90-minute, non-drug Preparatory Session, three Experimental Sessions with MDMA (~8 hours), and three 90-minute, non-drug Integration Sessions, occurring over a 9-15-week Treatment Period. Standardized homework is assigned at each CPT session to promote the practice of the skills taught in the session. Participants will receive 80mg MDMA HCl for the first Experimental Session and will have the option of a supplemental dose of 40mg MDMA HCI 1.5-2 hours after the initial dose. For the second and third Experimental Sessions, participants will receive either 80mg or 120mg MDMA HCl as the initial dose, and an optional supplemental dose of 40mg or 60mg MDMA HCl 1.5-2 hours after the initial dose. Participants interested in receiving CPT treatment alone after study completion will have the option to be referred to their local VA PTSD Clinical Team for services 6 months after all study visits are completed. |
| Cognitive processing therapy | Experimental | Behavioral: Cognitive Processing TherapyThis arm consists of 8-15 virtual CPT treatment sessions lasting approximately 1-1.5 hours, occurring over a ~12-16-week Treatment Period. These sessions will take place approximately one week apart. Standardized homework is assigned at each session to promote the practice of the skills taught in the session. Participants will have the option to crossover to the MDMA-aCPT arm 6 months after all study visits are completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Are at least 18 years at the time of signing the informed consent
- Are a U.S Military Veteran
- Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
- Are fluent in speaking and reading in English
Key exclusion criteria (13 listed)
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful
- Have current unstable medical illness
- Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
- Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
- Moderate or severe alcohol or cannabis use disorder within the last 12 months
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 |
|---|---|---|
| MDMAParticipants will receive a flexible divided-dose of MDMA HCl plus therapy at three Experimental Sessions, as well as non-drug Preparatory and Integration Sessions | Drug | MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) |
| Cognitive Processing TherapyParticipants will receive 8-15 (average of 12) sessions of Cognitive Processing Therapy | Behavioural | Cognitive processing therapy |
| MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)Participants assigned to MDMA-aCPT will undergo a therapeutic approach administered by trained therapists. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. MDMA can elicit feelings of empathy, love, and deep appreciation, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present. A combined treatment of MDMA and therapy may be especially useful for treating PTSD because MDMA can attenuate the fear response of a perceived threat to one's emotional integrity and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion. | Behavioural | MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) |
Primary outcome
Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score
Time frame: From Baseline to approximately 4 months post-baseline
The Primary Outcome measure will be the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Baseline to 4 months post-baseline assessed by a blinded study staff rater. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
1 secondary outcome
Change in Quality of Life Enjoyment and Satisfaction Questionnaire
Time frame: From Baseline to approximately 4 months post-baseline
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 31 Jul 2025.
- 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.
Trisha Suppes, MD, PhD principal investigator
VA Palo Alto Healthcare System / Stanford University
Shannon Wiltsey Stirman, PhD principal investigator
VA Palo Alto Healthcare System / Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDMA, Cognitive Processing Therapy and MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in people with PTSD, run by Patricia Suppes at 1 site 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 12 inclusion and 13 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Anna Donnelly (650-849-0161, exploratorytherapeuticslab@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score (time frame: From Baseline to approximately 4 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.