PTSDPhase 2NCT05746572
MDMA Plus Exposure Therapy for PTSD
A Phase 2 study testing MDMA in people with PTSD, run by Emory University at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) is a debilitating disorder. While effective treatments exist, some patients fail to receive the full benefits. Alternative treatment approaches are needed. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- MDMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 31 Oct 2026
- 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
- Meet criteria for PTSD
- Willingness of the participant to sign a release for the investigators to communicate with their primary care or mental health providers if indicated
- Are able to visually read and understand the English language and give written informed consent.
- Are able to swallow pills.
- Agree to have study visits and treatment sessions video and/or audio recorded,
- Must provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be reached by the investigators.
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- Must 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 prior to study entry, at study entry, and prior to the Medicine Session. Must agree to use adequate birth control for a month prior to 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 prior to Medicine Session, and not participate in any other interventional clinical trials during the duration of the study and 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 assessment, have any current or past diagnosis that would be considered a risk to participating in the study
- Current or past substance abuse that would be considered a risk for participating in the study
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- Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider.
- 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.
About this study
Official title: A Pilot Study of MDMA-Assisted Massed Exposure Therapy for PTSD (MDMA PE)
Posttraumatic stress disorder (PTSD) is a debilitating disorder. While effective treatments exist, some patients fail to receive the full benefits. Alternative treatment approaches are needed. 3,4-methylenedioxymethamphetamine (MDMA) is a medicine associated with feelings of closeness and love for others, empathy, insightfulness, and feelings of peace or well-being. Recent research combining one or two doses of MDMA with psychotherapy has shown improvements in PTSD symptoms.
For the present study, the researchers will investigate MDMA in combination with Prolonged Exposure therapy (PE), a gold-standard treatment for PTSD. All participants receive MDMA on the second day of a 10-day PE treatment program in which a PE therapy session occurs each day. This study will occur at the Emory Brain Health Center. Potential participants will be recruited via community advertising and mental health referrals.
Read more
The research team will also collect psychophysiological data for exploratory analyses regarding how MDMA may improve PE treatment for PTSD. This is an important study as it is the first time MDMA will be combined with an evidence-based existing PTSD treatment.
The study population will consist of people who meet the criteria for PTSD and are medically appropriate for MDMA administration.
Read the detailed description
Exposure-based interventions for PTSD have strong empirical support and involve helping PTSD patients confront feared trauma-related memories and triggers in a therapeutic manner so that distress decreases. This study will involve massed exposure therapy, which involves daily therapy sessions for two weeks, in combination with a one-time administration of MDMA. This is an open-label trial in which all enrolled participants will receive MDMA administration during treatment. An initial phone screen will be conducted for interested individuals to describe the study and assess eligibility. Following the phone screen, informed consent will occur. Interested individuals will also complete a drug test in their local community to be reviewed by the study team. For individuals interested in tapering their psychiatric medication, this may be done with a local provider or study physician. In this event, a psychiatric assessment will be conducted at the end of medication tapering to reassess eligibility.
For those who choose to participate and are eligible, the first day will include a medical and psychiatric assessment to confirm eligibility, a blood draw to check medical labs, a psychophysiological assessment, completion of self-report measures, and one therapy session. Additionally, an optional functional magnetic resonance imaging (fMRI) scan will be offered at the pre-treatment and end-of-treatment visits.
Upon confirmation of eligibility, the second day (or Medicine session) will involve MDMA administration followed by two therapy sessions with a break in between. A psychophysiological session will also occur on Day 2. Days 3-10 (which do not involve drug administration) will include a daily exposure therapy session. Psychophysiology will be collected during the therapy session. A psychophysiology session will occur on Days 4, 9, and 10 in addition to Days 1 and 2. Participants will be contacted at one week, two weeks, four weeks, and 6 months after treatment ends to complete symptom assessments via phone or online measures.
- Conditions
- PTSD
- Being tested
- MDMA
- Keywords
- MDMA, Massed Exposure Therapy
- 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
Also called MDMA-assisted massed exposure therapy, MDMA + PE
Participants will receive MDMA HCl (100 mg, 84 mg MDMA) in combination with massed exposure therapy for PTSD.
| Study group | Role | What they receive |
|---|---|---|
| Medicine Session | Experimental | 3,4-methylenedioxymethamphetamine (MDMA) in combination with massed exposure therapy for PTSD Receives: Drug: MDMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptoms
Measured by the change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score from baseline to 1-month post-treatment. The CAPS-5 is a structured clinician-administered measure that assesses the presence and severity of PTSD per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. All the DSM-5 symptoms of PTSD are assessed and rated on a scale from 0 (Absent) to 4 (Extremely Severe), with clear anchors provided to clinicians to assist with accurate ratings.
Measured: Baseline (day 1) and day 42 (+/- 2 days)
Secondary outcomes (1)
Effect of MDMA on massed exposure therapy on self-reported PTSD symptoms.
Measured by the change in the PTSD Checklist for DSM-5 (PCL-5) from baseline to 1-month post-treatment. The PCL-5 is a 20-item self-report measure of DSM-5 PTSD symptoms. Scores on the PCL range from 0 to 80.
Measured: Baseline (day 1) and day 42 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start13 Feb 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Maples-Keller, Emory University
- Investigators
- Jessica Maples-Keller, PhD, Principal investigator, Emory UniversityBarbara O Rothbaum, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746572
- Sponsor's protocol ID
- STUDY00000127
- Other IDs
- 2025P013168
- Status last verified
- Jul 2026
- First submitted
- 16 Feb 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maples-Keller JL, Dunlop BW, Rothbaum BO. The METEMP protocol: Massed exposure therapy enhanced with MDMA for PTSD. Contemp Clin Trials Commun. 2024 Nov 24;43:101400. doi: 10.1016/j.conctc.2024.101400. eCollection 2025 Feb.
PubMed 39895858
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of MDMA-Assisted Massed Exposure Therapy for PTSD (MDMA PE)
- ClinicalTrials.gov ID
- NCT05746572
- Acronym / sponsor ID
- STUDY00000127
- Conditions
- PTSD
- Keywords
- MDMA, Massed Exposure Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Feb 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.
Posttraumatic stress disorder (PTSD) is a debilitating disorder. While effective treatments exist, some patients fail to receive the full benefits. Alternative treatment approaches are needed. 3,4-methylenedioxymethamphetamine (MDMA) is a medicine associated with feelings of closeness and love for others, empathy, insightfulness, and feelings of peace or well-being. Recent research combining one or two doses of MDMA with psychotherapy has shown improvements in PTSD symptoms.
For the present study, the researchers will investigate MDMA in combination with Prolonged Exposure therapy (PE), a gold-standard treatment for PTSD. All participants receive MDMA on the second day of a 10-day PE treatment program in which a PE therapy session occurs each day. This study will occur at the Emory Brain Health Center. Potential participants will be recruited via community advertising and mental health referrals.
The research team will also collect psychophysiological data for exploratory analyses regarding how MDMA may improve PE treatment for PTSD. This is an important study as it is the first time MDMA will be combined with an evidence-based existing PTSD treatment.
The study population will consist of people who meet the criteria for PTSD and are medically appropriate for MDMA administration.
Detailed description
Exposure-based interventions for PTSD have strong empirical support and involve helping PTSD patients confront feared trauma-related memories and triggers in a therapeutic manner so that distress decreases. This study will involve massed exposure therapy, which involves daily therapy sessions for two weeks, in combination with a one-time administration of MDMA. This is an open-label trial in which all enrolled participants will receive MDMA administration during treatment. An initial phone screen will be conducted for interested individuals to describe the study and assess eligibility. Following the phone screen, informed consent will occur. Interested individuals will also complete a drug test in their local community to be reviewed by the study team. For individuals interested in tapering their psychiatric medication, this may be done with a local provider or study physician. In this event, a psychiatric assessment will be conducted at the end of medication tapering to reassess eligibility.
For those who choose to participate and are eligible, the first day will include a medical and psychiatric assessment to confirm eligibility, a blood draw to check medical labs, a psychophysiological assessment, completion of self-report measures, and one therapy session. Additionally, an optional functional magnetic resonance imaging (fMRI) scan will be offered at the pre-treatment and end-of-treatment visits.
Upon confirmation of eligibility, the second day (or Medicine session) will involve MDMA administration followed by two therapy sessions with a break in between. A psychophysiological session will also occur on Day 2. Days 3-10 (which do not involve drug administration) will include a daily exposure therapy session. Psychophysiology will be collected during the therapy session. A psychophysiology session will occur on Days 4, 9, and 10 in addition to Days 1 and 2. Participants will be contacted at one week, two weeks, four weeks, and 6 months after treatment ends to complete symptom assessments via phone or online measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medicine Session | Experimental | Drug: MDMA3,4-methylenedioxymethamphetamine (MDMA) in combination with massed exposure therapy for PTSD |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet criteria for PTSD
- Willingness of the participant to sign a release for the investigators to communicate with their primary care or mental health providers if indicated
- Are able to visually read and understand the English language and give written informed consent.
- Are able to swallow pills.
- Agree to have study visits and treatment sessions video and/or audio recorded,
Key exclusion criteria (20 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 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 |
|---|---|---|
| MDMAAlso: MDMA-assisted massed exposure therapy, MDMA + PEParticipants will receive MDMA HCl (100 mg, 84 mg MDMA) in combination with massed exposure therapy for PTSD. | Drug | Medicine Session |
Primary outcome
Effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptoms
Time frame: Baseline (day 1) and day 42 (+/- 2 days)
Measured by the change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score from baseline to 1-month post-treatment. The CAPS-5 is a structured clinician-administered measure that assesses the presence and severity of PTSD per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. All the DSM-5 symptoms of PTSD are assessed and rated on a scale from 0 (Absent) to 4 (Extremely Severe), with clear anchors provided to clinicians to assist with accurate ratings.
1 secondary outcome
Effect of MDMA on massed exposure therapy on self-reported PTSD symptoms.
Time frame: Baseline (day 1) and day 42 (+/- 2 days)
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 Jul 2026.
- Derived from this study: PubMed 39895858Maples-Keller JL, Dunlop BW, Rothbaum BO. The METEMP protocol: Massed exposure therapy enhanced with MDMA for PTSD. Contemp Clin Trials Commun. 2024 Nov 24;43:101400. doi: 10.1016/j.conctc.2024.101400. eCollection 2025 Feb.
- 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.
Jessica Maples-Keller, PhD principal investigator
Emory University
Barbara O Rothbaum, 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 MDMA in people with PTSD, 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 20 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: enrolling by invitation, as of the sponsor's last update on 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptoms (time frame: Baseline (day 1) and day 42 (+/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746572, which also lists 1 linked publication.
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 Jul 2026; AzTrials last refreshed its copy on 5 Nov 2026.