Post Traumatic Stress DisorderPhase 2NCT07288151
MDMA-Assisted Massed Exposure Therapy for PTSD
A Phase 2 study testing 3,4-Methylenedioxymethamphetamine (MDMA) and Massed Prolonged Exposure (PE) in people with Post Traumatic Stress Disorder, run by Emory University at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- 3,4-Methylenedioxymethamphetamine (MDMA) and Massed Prolonged Exposure (PE)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jan 2030
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).
- Able to speak and read English (due to standardization of outcome measures).
- Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.
- Able to swallow pills.
- Agree to have study visits video and/or audio recorded, including Experimental Session, assessments, and non-drug therapy sessions.
- Willing to provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be contacted by the investigators.
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- Agree to inform the investigators within 48 hours of any medical conditions and procedures.
- If able to become pregnant, must have a negative pregnancy test before study entry, at study entry, and before the Medicine Session. Must agree to use adequate birth control for a month before the Medicine session and through 10 days after the Medicine Session.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications before the Medicine Session, and not participating in any other interventional clinical trials during the duration of the study, are driven home or to a hotel after the Medicine Session, and commit to medication dosing, therapy, and study procedures
Who cannot join
- Are not able to give adequate informed consent.
- Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.
- Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).
- Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to participating in the study
- Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider.
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- Have a history of any medical condition that could make receiving MDMA dangerous because of increases in blood pressure and heart rate or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism is exclusionary.
- Have any unstable medical condition that would interfere with participation.
- Have uncontrolled hypertension) documented on three separate occasions.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Have a history of ever having ventricular arrhythmia or any other abnormal heart rhythm that the study physician believes would pose a significant risk of participation.
- Have an abnormal finding on electrocardiogram
- Have a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Require the use of concomitant medications that could impact the effects or safety of MDMA during the Medicine Session.
- Have symptomatic liver disease or significant liver enzyme elevations.
- Have a history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms (105 lbs.).
- Are pregnant or nursing
- Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syreese Fuller contact
United States1 site, 1 recruiting
- Recruiting
Emory Brain Health Center
Atlanta, Georgia, 30329
Jessica Maples-Keller, PhD, 404-712-1035, patstudy@emory.edu
About this study
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants.
The main questions it aims to answer are:
Read more
- Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo?
- Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo?
- Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes?
Participants will:
- Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks
- Be administered either 100 mg of MDMA or a placebo at Visit 2
- Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up
Read the detailed description
Posttraumatic stress disorder (PTSD) affects many individuals, including military veterans and civilians exposed to trauma. While trauma-focused therapies like Prolonged Exposure (PE) are effective, many people do not fully recover, and current medications often have limited success.
This study will test whether combining PE therapy with a single dose of MDMA (a psychoactive drug) can improve PTSD treatment outcomes. Ninety-five participants with PTSD will be randomly assigned to receive either MDMA or a placebo during the second of ten PE therapy sessions, which are delivered over two weeks. Researchers will measure PTSD symptoms one month after treatment using a standardized interview.
The study will also explore how MDMA affects brain responses related to fear and emotional memory, which may help explain how it works. Early results from a pilot study suggest this combination may lead to large reductions in PTSD symptoms. This is the first clinical trial to formally test MDMA with PE therapy, and it may lead to new, more effective treatment options for PTSD.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- 3,4-Methylenedioxymethamphetamine (MDMA), Placebo, Massed Prolonged Exposure (PE)
- Keywords
- MDMA, 3,4-Methylenedioxymethamphetamine, Massed prolonged exposure therapy, Pos traumatic stress disorder
- 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.
3,4-Methylenedioxymethamphetamine (MDMA)Drug
Also called MDMA
MDMA is a synthetic compound, commonly administered as MDMA hydrochloride (HCl).
The drug will be administered in 100mg doses for a single session on Visit 2 out of 10- day study sessions over 2 weeks. MDMA is administered orally in capsule form and is taken under supervision in a controlled, therapeutic environment
PlaceboDrug
Placebos will visually match the 3 MDMA capsules (40mg, 40mg, and 20mg).
Massed Prolonged Exposure (PE)Behavioural
Massed exposure therapy will be conducted for 11 sessions, 10 daily sessions and an additional therapy session during V2. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy.
Also consistent with this treatment manual, participants will listen to imaginal exposures outside of PE sessions for "homework."
| Study group | Role | What they receive |
|---|---|---|
| MDMA group | Experimental | Not described Receives: Drug: 3,4-Methylenedioxymethamphetamine (MDMA); Behavioral: Massed Prolonged Exposure (PE) |
| Standard of Care | Placebo comparator | Not described Receives: Drug: Placebo; Behavioral: Massed Prolonged Exposure (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PTSD symptoms measured by CAPS-5-R
The CAPS-5-R is a structured clinical interview used to assess PTSD symptoms based on DSM-5 criteria. Each symptom is rated on frequency and intensity
- Combined into a severity score per item
- Total score reflects overall PTSD symptom severity
Measured: Baseline, 1 month post-treatment
Secondary outcomes (2)
Changes in PTSD symptoms measured by PCL-5
The PCL-5 is a 20-item self-report questionnaire used to measure PTSD symptoms based on DSM-5 criteria. Participants rate how much they've been bothered by each symptom in relation to a specific traumatic event, using a scale from 0 ("Not at all") to 4 ("Extremely"). A total score of 33 or higher indicates clinically elevated PTSD symptoms
Measured: Baseline, 1 month post treatment
Change in PHQ questionnaire scores
The PHQ-9 is a questionnaire used to assess depression severity. Each of the 9 items is scored from 0 to 3, giving a total score between 0 and 27.
Higher scores suggest more severe depressive symptoms.
Measured: Baseline, 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study startJul 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Jessica Maples-Keller, Emory University
- Investigators
- Jessica Maples-Keller, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288151
- Sponsor's protocol ID
- 2025P012039
- Other IDs
- TP240376
- Status last verified
- May 2026
- First submitted
- 15 Dec 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDMA-Assisted Massed Exposure Therapy for PTSD
- ClinicalTrials.gov ID
- NCT07288151
- Acronym / sponsor ID
- 2025P012039
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- MDMA, 3,4-Methylenedioxymethamphetamine, Massed prolonged exposure therapy, Pos traumatic stress disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Dec 2025 (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.
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants.
The main questions it aims to answer are:
- Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo?
- Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo?
- Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes?
Participants will:
- Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks
- Be administered either 100 mg of MDMA or a placebo at Visit 2
- Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up
Detailed description
Posttraumatic stress disorder (PTSD) affects many individuals, including military veterans and civilians exposed to trauma. While trauma-focused therapies like Prolonged Exposure (PE) are effective, many people do not fully recover, and current medications often have limited success.
This study will test whether combining PE therapy with a single dose of MDMA (a psychoactive drug) can improve PTSD treatment outcomes. Ninety-five participants with PTSD will be randomly assigned to receive either MDMA or a placebo during the second of ten PE therapy sessions, which are delivered over two weeks. Researchers will measure PTSD symptoms one month after treatment using a standardized interview.
The study will also explore how MDMA affects brain responses related to fear and emotional memory, which may help explain how it works. Early results from a pilot study suggest this combination may lead to large reductions in PTSD symptoms. This is the first clinical trial to formally test MDMA with PE therapy, and it may lead to new, more effective treatment options for PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDMA group | Experimental | Drug: 3,4-Methylenedioxymethamphetamine (MDMA), Behavioral: Massed Prolonged Exposure (PE) |
| Standard of Care | Placebo comparator | Drug: Placebo, Behavioral: Massed Prolonged Exposure (PE) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).
- Able to speak and read English (due to standardization of outcome measures).
- Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.
- Able to swallow pills.
- Agree to have study visits video and/or audio recorded, including Experimental Session, assessments, and non-drug therapy sessions.
Key exclusion criteria (19 listed)
- Are not able to give adequate informed consent.
- Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.
- Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).
- Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to participating in the study
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 |
|---|---|---|
| 3,4-Methylenedioxymethamphetamine (MDMA)Also: MDMAMDMA is a synthetic compound, commonly administered as MDMA hydrochloride (HCl). The drug will be administered in 100mg doses for a single session on Visit 2 out of 10- day study sessions over 2 weeks. MDMA is administered orally in capsule form and is taken under supervision in a controlled, therapeutic environment | Drug | MDMA group |
| PlaceboPlacebos will visually match the 3 MDMA capsules (40mg, 40mg, and 20mg). | Drug | Standard of Care |
| Massed Prolonged Exposure (PE)Massed exposure therapy will be conducted for 11 sessions, 10 daily sessions and an additional therapy session during V2. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy. Also consistent with this treatment manual, participants will listen to imaginal exposures outside of PE sessions for "homework." | Behavioural | MDMA group, Standard of Care |
Primary outcome
Changes in PTSD symptoms measured by CAPS-5-R
Time frame: Baseline, 1 month post-treatment
The CAPS-5-R is a structured clinical interview used to assess PTSD symptoms based on DSM-5 criteria. Each symptom is rated on frequency and intensity * Combined into a severity score per item * Total score reflects overall PTSD symptom severity
2 secondary outcomes
Changes in PTSD symptoms measured by PCL-5
Time frame: Baseline, 1 month post treatment
Change in PHQ questionnaire scores
Time frame: Baseline, 1 month post-treatment
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 26 May 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.
Syreese Fuller contact
Jessica Maples-Keller, PhD principal investigator
Emory 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 3,4-Methylenedioxymethamphetamine (MDMA) and Massed Prolonged Exposure (PE) in people with Post Traumatic Stress Disorder, run by Emory University 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 19 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 26 May 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. Some participants in this study may receive a placebo. 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 Jessica Maples-Keller, PhD (404-712-1035, patstudy@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PTSD symptoms measured by CAPS-5-R (time frame: Baseline, 1 month post-treatment). 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 26 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.