Post Traumatic Stress DisorderPhase 2NCT07569159
MDMA Therapy in Veterans With PTSD
A Phase 2 study testing MDMA in people with Post Traumatic Stress Disorder, run by Sunstone Medical at 1 site in United States.
Trial summary
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- MDMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans who are at least 18 years old
- Are able to swallow pills
- Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
- Proficient in speaking and reading English.
Who cannot join
- Condition impairing oral intake or digestive absorption.
- Unable to give adequate informed consent.
- Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months
- Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)
- A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.
- Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.
- Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kalisha Watkins contact
United States1 site, 1 recruiting
- Recruiting
Sunstone Therapies
Rockville, Maryland, 20850
Manish Agarwal
Michelle Leff
About this study
Official title: A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- MDMA
- 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
MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.
| Study group | Role | What they receive |
|---|---|---|
| Individual | Experimental | Not described Receives: Drug: MDMA |
| Group | Experimental | Not described Receives: Drug: MDMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.
Measured: 15 months
C-SSRS
Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale [C-SSRS]) score at all visits from Baseline to EOS Visit.
Measured: 15 months
Secondary outcomes (7)
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Clinician Administered PTSD Scale. (CAPS-5)
Measured: 15 months
Effect of Therapy
To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Sheehan Disability Scale. (SDS)
Measured: 15 months
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the PTSD Checklist for DSM-5.(PCL-5)
Measured: 15 months
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the State-Trait Anxiety Inventory. (STAI)
Measured: 15 months
Efficacy of Therapy
To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Quick Inventory of Depressive Symptomatology- Self-Report. ( QIDS-SR-16)
Measured: 15 months
Effect of Therapy
To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the EQ-5D-5L.
Measured: 15 months
Effects of Therapy
To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Clinician Administered PTSD Scale. (CAPS-5)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunstone Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Agarwal, Principal investigator, Sunstone Medical, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569159
- Sponsor's protocol ID
- SUN005
- Other IDs
- MD Grant
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2025
- Last updated
- 1 Jul 2026
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07569159
- Acronym / sponsor ID
- SUN005
- Conditions
- Post Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sunstone MedicalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 May 2026 (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.
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual | Experimental | Drug: MDMA |
| Group | Experimental | Drug: MDMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans who are at least 18 years old
- Are able to swallow pills
- Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
- Proficient in speaking and reading English.
Key exclusion criteria (7 listed)
- Condition impairing oral intake or digestive absorption.
- Unable to give adequate informed consent.
- Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months
- Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)
- A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.
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 |
|---|---|---|
| MDMAMDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912. | Drug | Group, Individual |
Primary outcome
Safety and Tolerability
Time frame: 15 months
To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.
C-SSRS
Time frame: 15 months
Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale [C-SSRS]) score at all visits from Baseline to EOS Visit.
7 secondary outcomes
Efficacy of Therapy
Time frame: 15 months
Effect of Therapy
Time frame: 15 months
Efficacy of Therapy
Time frame: 15 months
Efficacy of Therapy
Time frame: 15 months
Efficacy of Therapy
Time frame: 15 months
Effect of Therapy
Time frame: 15 months
Effects of Therapy
Time frame: 15 months
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 1 Jul 2026.
- 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.
Kalisha Watkins contact
Manish Agarwal principal investigator
Sunstone Medical, PC
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 in people with Post Traumatic Stress Disorder, run by Sunstone Medical 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 4 inclusion and 7 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 1 Jul 2026. 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 Clinical Evaluation Team ((301) 750-3401, clinical.specialists@sunstonetherapies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 15 months). 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?
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 1 Jul 2026.