Posttraumatic Stress DisorderPhase 2DosOpNCT06418178
Dose Optimization of MDMA-Assisted Therapy for PTSD
A Phase 2 study testing Midomafetamine and Psychotherapy in people with Posttraumatic Stress Disorder, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Midomafetamine and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to Oct 2029
- 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
- Are a U.S. military veteran at least 18 years old.
- Are able to provide written, informed consent.
- Are able to swallow pills.
- Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
- Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.
- If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods.
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- Must have a current PTSD diagnosis at screening and baseline.
- Must not participate in any other interventional clinical trials for the duration of the study.
- Must commit to medication dosing, therapy, and all study procedures.
Who cannot join
- Are not able to give adequate informed consent.
- Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful.
- Have uncontrolled hypertension.
- Have evidence or history of significant medical or psychiatric disorders.
- Have symptomatic liver disease.
- Have history of hyponatremia or hyperthermia.
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- Weigh less than 48 kilograms (kg).
- Unable or unwilling to safely taper off prohibited psychiatric medication.
- Abusing illegal drugs or alcohol.
- Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment.
- Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception.
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
James J. Peters VA Medical Center
The Bronx, New York, 10468
Lesley Lu, 9297363104, yongyi.lu@va.gov
About this study
Official title: A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans
This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.
Read the detailed description
This open label, within-subjects dose optimization study will determine the optimal number of treatment cycles of MDMA-AT (one cycle consists of one Experimental Session followed by three Integrative Sessions) for significant improvement in a sample of U.S. veterans with PTSD. All participants will receive three non-drug preparatory sessions and at least one cycle of MDMA-assisted therapy with a team of two therapists. Each cycle will consist of one approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions. After each cycle, participants will determine, in consultation with their therapy team, whether to continue with an additional cycle or to discontinue treatment. The decision will reflect the participant's perception of the potential for continued improvement (e.g., as based on current symptom burden, treatment response to date) weighed against the burden of an additional cycle (e.g., time required, any adverse events or emotional burden). Participants may complete up to a maximum of five cycles. The dose optimizing design allows for the identification of the optimal number of MDMA-AT cycles to achieve the best response and to assess tolerability of multiple cycles of MDMA-AT. Participants will also provide blood samples to be banked for future analysis of biological markers associated with treatment response.
For each participant, the study will consist of:
- Screening Period: initial screen, informed consent, eligibility assessment
- Enrollment Period with Enrollment Confirmation: Enrollment and medication tapering period (if needed) followed by psychological assessment and Enrollment Confirmation, collection of biomarker blood samples.
- Treatment Period: 3 Preparatory sessions; one to five Experimental Sessions, each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists
- Post-treatment Period and Study Termination: Psychological Evaluation, biomarker blood samples, study termination visit
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Midomafetamine, Psychotherapy
- Keywords
- Posttraumatic Stress Disorder, MDMA-Assisted Therapy, Dose Optimization, Veterans
- 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.
MidomafetamineDrug
Also called MDMA, 3,4-methylenedioxymethamphetamine
One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)
PsychotherapyBehavioural
Standardized psychotherapy performed by therapy team
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Open label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions. Receives: Drug: Midomafetamine; Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms per DSM-5. Participants indicate how much distress they have experienced due to each symptom on a five-point Likert-type scale (1=Not at all to 5=Extremely).
Measured: From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles)
Secondary outcomes (1)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The last month CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure and past-month symptom severity to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation.
Measured: From Pre-treatment Psychological Evaluation to Post-treatment Psychological Evaluation (up to ~28 weeks for participants who complete all five treatment cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start3 Jun 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Rachel Yehuda, Bronx VA Medical Center
- Investigators
- Rachel Yehuda, PhD, Principal investigator, James J. Peters VA Medical CenterAmy Lehrner, PhD, Principal investigator, James J. Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418178
- Sponsor's protocol ID
- 171633
- Acronym
- DosOp
- Status last verified
- Oct 2026
- First submitted
- 6 May 2024
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans
- ClinicalTrials.gov ID
- NCT06418178
- Acronym / sponsor ID
- DosOp / 171633
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, MDMA-Assisted Therapy, Dose Optimization, Veterans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 17 May 2024 (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.
This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.
Detailed description
This open label, within-subjects dose optimization study will determine the optimal number of treatment cycles of MDMA-AT (one cycle consists of one Experimental Session followed by three Integrative Sessions) for significant improvement in a sample of U.S. veterans with PTSD. All participants will receive three non-drug preparatory sessions and at least one cycle of MDMA-assisted therapy with a team of two therapists. Each cycle will consist of one approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions. After each cycle, participants will determine, in consultation with their therapy team, whether to continue with an additional cycle or to discontinue treatment. The decision will reflect the participant's perception of the potential for continued improvement (e.g., as based on current symptom burden, treatment response to date) weighed against the burden of an additional cycle (e.g., time required, any adverse events or emotional burden). Participants may complete up to a maximum of five cycles. The dose optimizing design allows for the identification of the optimal number of MDMA-AT cycles to achieve the best response and to assess tolerability of multiple cycles of MDMA-AT. Participants will also provide blood samples to be banked for future analysis of biological markers associated with treatment response.
For each participant, the study will consist of:
- Screening Period: initial screen, informed consent, eligibility assessment
- Enrollment Period with Enrollment Confirmation: Enrollment and medication tapering period (if needed) followed by psychological assessment and Enrollment Confirmation, collection of biomarker blood samples.
- Treatment Period: 3 Preparatory sessions; one to five Experimental Sessions, each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists
- Post-treatment Period and Study Termination: Psychological Evaluation, biomarker blood samples, study termination visit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Midomafetamine, Behavioral: PsychotherapyOpen label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are a U.S. military veteran at least 18 years old.
- Are able to provide written, informed consent.
- Are able to swallow pills.
- Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
- Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.
Key exclusion criteria (11 listed)
- Are not able to give adequate informed consent.
- Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful.
- Have uncontrolled hypertension.
- Have evidence or history of significant medical or psychiatric disorders.
- Have symptomatic liver disease.
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 |
|---|---|---|
| MidomafetamineAlso: MDMA, 3,4-methylenedioxymethamphetamineOne to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below) | Drug | Treatment Arm |
| PsychotherapyStandardized psychotherapy performed by therapy team | Behavioural | Treatment Arm |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles)
The PCL-5 is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms per DSM-5. Participants indicate how much distress they have experienced due to each symptom on a five-point Likert-type scale (1=Not at all to 5=Extremely).
1 secondary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: From Pre-treatment Psychological Evaluation to Post-treatment Psychological Evaluation (up to ~28 weeks for participants who complete all five treatment cycles)
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 8 Oct 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.
Rachel Yehuda, PhD principal investigator
James J. Peters VA Medical Center
Amy Lehrner, PhD principal investigator
James J. Peters VA Medical Center
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 Midomafetamine and Psychotherapy in people with Posttraumatic Stress Disorder, run by Bronx VA Medical Center 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 9 inclusion and 11 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 8 Oct 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 Amy Lehrner, PhD (718-584-9000 ext. 3205, Amy.Lehrner@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles)). 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 8 Oct 2026.