Posttraumatic Stress Disorder (PTSD)Phase 2NCT07765693
MDMA-AT for PTSD in Young Adults With Childhood Trauma
A Phase 2 study testing MDMA assisted psychotherapy in people with Posttraumatic Stress Disorder (PTSD), run by Jenna M. Traynor at 1 site in United States.
Trial summary
This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT). Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- MDMA assisted psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 1 Dec 2028
- 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 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Demographic and Participant Information
- Between the ages of 18-26 years old upon signing the written consent form
- Proficient in speaking and reading English.
- Capable of providing informed consent.
- Is able to swallow pills.
- Willing and able to be contacted by phone throughout the study
Show all 23Show fewer
- Resides in the United States
- Meets DSM-5 criteria for PTSD with sufficient severity assessed at study screening
- History of index Criterion A trauma that occurred in childhood
- Must agree to inform the research team within 48 hours of any emerging or new medical conditions and/or procedures
- Must provide an emergency contact
- Has someone to drive them home after each MDMA-AT session (or agrees to take a taxi/rideshare while accompanied by a close other)
- Agree not to drive for 24 hours after each MDMA-AT session
- Agree to return to place of residence immediately after each MDMA-AT session, and stay there until the next morning
- Has a trusted close other who is at least 18 years of age that agrees to stay with them throughout the night until the morning after each MDMA-AT session, and is willing to attend the ICF meeting and co-sign the ICF
- Agree to not participate in any other interventional clinical trials from baseline to the primary study endpoint
- Is willing and able to refrain from taking any psychiatric medications during the study period.
- Agrees to abstain from other medications (e.g., over the counter, PRN medications, etc) unless approval from PI has been obtained
- If able to become pregnant:
- Must have a negative pregnancy screen during study screening and on the morning of each MDMA-AT session;
- Must agree to use adequate birth control for the duration of participation
- Has a primary care provider (PCP)
- Has a regular outpatient mental health treater (e.g., psychiatrist, psychologist) that will resume care for the participant following completion or termination of study participation
Who cannot join
- Recently attempted suicide or engaged in high risk self-injury or is otherwise assessed to be at imminent risk of suicide by study staff
- In the opinion of the PI, would present a serious risk to others as established through study screening measures or clinical observations.
- Meets DSM-5 criteria for any current substance use disorder, other than alcohol, cannabis, or nicotine use disorder
- For cannabis use and alcohol use disorders without physiological dependence, must agree to be abstinent from alcohol and cannabis for one week prior to and following each MDMA-AT session.
- Meets DSM-5 criteria for current cannabis or alcohol use disorder with physiological dependence, or physiological dependence cannot be determined
- Meets other DSM-5 criteria for serious mental illness, as assessed by the DART or through clinical interviews or observations
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- Has a current restrictive eating disorder with current low body-mass index, or any eating disorder with active purging, currently, or in the 3 months prior to enrollment
- Diagnosed major neurodevelopmental or neurological disorder.
- Scaled score on the Test of Premorbid Functioning that is suggestive of possible cognitive impairment.
- Has used MDMA in the month prior to enrollment
- Has used MDMA excessively in the past
- Has participated in a previous MDMA-AT for PTSD clinical trial
- Has hypersensitivity to any ingredient of the Investigational Product
- Requires ongoing concomitant therapy with a psychiatric drug, excluding gabapentin.
- Is currently receiving trauma-focused psychotherapy and unwilling or unable to put treatment on hold for the duration of active study participation
- Has received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Has received ketamine infusions and/or ketamine-assisted therapy in the 8 weeks prior to enrolment
- Requires the use of opiates for pain management
- Currently on methadone maintenance treatment
- Has symptomatic liver disease or significant liver enzyme elevation
- Weighs less than 48 kg (105 lbs)
- History of concussion with loss of consciousness ≥ 24 hours or traumatic brain injury
- History of hyponatremia or hyperthermia.
- Any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate.
- Uncontrolled hypertension
- History of arrythmia (e.g., atrial or ventricular arrhythmia) at any time, other than occasional premature atrial contractions (PACs) or premature ventricular contractions (PVCs) in the absence of ischemic heart disease, within 12 months of screening.
- History of tachycardia or cardiac disorder.
- Has Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- marked Baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms) in males and >460 ms in females corrected by Fridericia's formula). For transgender or non- binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for five or more years.
- History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Requires use of concomitant medications that prolong the QT/QTc interval
- Standard MRI contraindications
- Is pregnant or nursing, planning to become pregnant during the course of the study, or is able to become pregnant and not practicing an effective means of birth control.
- In the opinion of the PI, participant's current place of residence is unstable
- Is currently engaged in compensation litigation whereby financial gain would be achieved from prolonged psychiatric symptoms
- Requires a legally authorized representative to provide informed consent
- In the opinion of the study PI, is not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support
- Is participating in another interventional clinical trial at any point from study screening to the primary study endpoint (i.e., post-treatment visit)
- Does not reside in the US
- Substantial colorblindness sufficient to impede performance on the fMRI tasks
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
McLean Hospital
Belmont, Massachusetts, 02478
Alexandra Velev, BA, 617-855-3430, avelev@mclean.harvard.edu
About this study
Official title: MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder in Young Adults With Childhood Trauma: An Open-Label Pilot Study
This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).
The main questions it aims to answer are:
Read more
- Is the treatment safe and feasible to administer?
- Does the treatment improve PTSD symptoms?
Participants will be asked to:
- Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation
- Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session
- Attend three integration talk therapy sessions after each MDMA-AT dosing session
- Attend up to three total MDMA-AT dosing sessions
- Complete assessments from baseline to 38-weeks post-baseline
- Complete a fMRI scan at baseline and at 18-weeks post-treatment
- Complete self-report measures and ecological momentary assessments (EMAs) across the study period
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- MDMA assisted psychotherapy
- Keywords
- Young adults, Ages 18-26, MDMA, Posttraumatic Stress Disorder, PTSD
- 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.
MDMA assisted psychotherapyDrug
Recruiting young adults with PTSD for an interventional study testing a combination of MDMA and talk therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: MDMA-AT for PTSD | Experimental | Open-label MDMA-assisted therapy (up to three sessions of 120mg MDMA) Receives: Drug: MDMA assisted psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
The safety of MDMA-AT will be assessed by the number, type, and severity of adverse events.
Measured: Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline).
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The efficacy of MDMA-AT will be assessed using the CAPS-5 total severity score. The CAPS-5 is a 30-item structured clinical interview used to diagnose PTSD, including overall PTSD severity. The severity score ranges from 0 to 80, with higher scores indicating greater overall severity of PTSD symptoms
Measured: From baseline to 18-weeks post-baseline.
Secondary outcomes (5)
The PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure of PTSD symptom severity. Responses range from 0 (not at all) to 4 (extremely), and total scores range from 0-80, with higher scores indicating greater PTSD symptom severity.
Measured: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
The Inventory of Altered Self Capacities (IASC)
The IASC is a 63-item self-report measure of problems in identity, affect regulation, and interpersonal functioning. The scale produces a total score and seven subscores (representing Interpersonal Conflicts; Idealizing-Devaluing; Abandonment Concerns; Identity Impairment; Susceptibility to Influence; Emotion Dysregulation; and Tension Reduction Activities) representing common areas of impairment in individuals with PTSD as a result of childhood trauma.
Measured: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Cognitive Flexibility Inventory (CFI)
The CFI is a 20-item self-report measure of adaptive cognitive responses to stressful life events. Responses range from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 20 and 140, where higher scores indicate more cognitive flexibility.
Measured: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Self Compassion Scale Short Form (SCS-SF)
The SCS-SF is a 12-item self-report measure of self-kindness. It is made up of six Self Care items and the six Self Disparagement. Responses range from 1 (almost never) to 5 (almost always), with higher scores indicating high Self Care together with low Self Disparagement.
Measured: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Sheehan Disability Scale (SDS)
The SDS is 3-item a self-report measure that assesses measures impairment in three domains: work/school, social life/leisure activities, and family life/home responsibilities. A total score ranges from 0 (no impairment) to 30 (severe impairment).
Measured: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jenna M. Traynor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jenna M. Traynor, Mclean Hospital
- Investigators
- Jenna M Traynor, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765693
- Sponsor's protocol ID
- 2026P000839
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is an internal, Phase II study and there are no current plans to share IPD with personnel outside of Mass General Brigham (MGB). In the event that a decision is made in the future to share data from this research study with collaborators outside of MGB, data will be de-identified and aggregated prior to sharing and will comply with all relevant MGB data sharing policies. The possibility that data may be shared with outside collaborators will be clearly outlined in the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder in Young Adults With Childhood Trauma: An Open-Label Pilot Study
- ClinicalTrials.gov ID
- NCT07765693
- Acronym / sponsor ID
- 2026P000839
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Young adults, Ages 18-26, MDMA, Posttraumatic Stress Disorder, PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jenna M. TraynorUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Aug 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.
This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).
The main questions it aims to answer are:
- Is the treatment safe and feasible to administer?
- Does the treatment improve PTSD symptoms?
Participants will be asked to:
- Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation
- Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session
- Attend three integration talk therapy sessions after each MDMA-AT dosing session
- Attend up to three total MDMA-AT dosing sessions
- Complete assessments from baseline to 38-weeks post-baseline
- Complete a fMRI scan at baseline and at 18-weeks post-treatment
- Complete self-report measures and ecological momentary assessments (EMAs) across the study period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: MDMA-AT for PTSD | Experimental | Drug: MDMA assisted psychotherapyOpen-label MDMA-assisted therapy (up to three sessions of 120mg MDMA) |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Demographic and Participant Information
- Between the ages of 18-26 years old upon signing the written consent form
- Proficient in speaking and reading English.
- Capable of providing informed consent.
- Is able to swallow pills.
Key exclusion criteria (40 listed)
- Recently attempted suicide or engaged in high risk self-injury or is otherwise assessed to be at imminent risk of suicide by study staff
- In the opinion of the PI, would present a serious risk to others as established through study screening measures or clinical observations.
- Meets DSM-5 criteria for any current substance use disorder, other than alcohol, cannabis, or nicotine use disorder
- For cannabis use and alcohol use disorders without physiological dependence, must agree to be abstinent from alcohol and cannabis for one week prior to and following each MDMA-AT session.
- Meets DSM-5 criteria for current cannabis or alcohol use disorder with physiological dependence, or physiological dependence cannot be determined
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 |
|---|---|---|
| MDMA assisted psychotherapyRecruiting young adults with PTSD for an interventional study testing a combination of MDMA and talk therapy. | Drug | Experimental: MDMA-AT for PTSD |
Primary outcome
Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Time frame: Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline).
The safety of MDMA-AT will be assessed by the number, type, and severity of adverse events.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: From baseline to 18-weeks post-baseline.
The efficacy of MDMA-AT will be assessed using the CAPS-5 total severity score. The CAPS-5 is a 30-item structured clinical interview used to diagnose PTSD, including overall PTSD severity. The severity score ranges from 0 to 80, with higher scores indicating greater overall severity of PTSD symptoms
5 secondary outcomes
The PTSD Checklist for DSM-5 (PCL-5)
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
The Inventory of Altered Self Capacities (IASC)
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Cognitive Flexibility Inventory (CFI)
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Self Compassion Scale Short Form (SCS-SF)
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).
Sheehan Disability Scale (SDS)
Time frame: From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks 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 20 Aug 2026.
- Individual participant dataSharing planned: No. This is an internal, Phase II study and there are no current plans to share IPD with personnel outside of Mass General Brigham (MGB). In the event that a decision is made in the future to share data from this research study with collaborators outside of MGB, data will be de-identified and aggregated prior to sharing and will comply with all relevant MGB data sharing policies. The possibility that data may be shared with outside collaborators will be clearly outlined in the informed consent form.
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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.
Jenna M Traynor principal investigator
Mclean Hospital
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 assisted psychotherapy in people with Posttraumatic Stress Disorder (PTSD), run by Jenna M. Traynor 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 23 inclusion and 40 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: opening soon, as of the sponsor's last update on 20 Aug 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 Alexandra Velev, BA (617-855-3430, avelev@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest (time frame: Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline).). 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 20 Aug 2026.