MDMA brain study on PTSD never got off the ground
NCT ID NCT03752918
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see how MDMA changes brain activity in people with PTSD, especially in areas that handle emotions. Researchers planned to give MDMA to a small group and measure brain scans and PTSD symptoms. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
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May 2024
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males or females between the ages of 21-55 years. Females will be included if they are not pregnant and agreed to utilize a medically (non-hormonal)\* accepted birth control method (to include implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile. * Able to provide written informed consent according to Yale HIC guidelines. * Able to read and write English as a primary language. * Diagnosis of PTSD, as determined by the Clinician Administered PTSD Scale (CAPS-5). * Must have a score of 23 or higher on the Clinician-Administered PTSD Scale (CAPS-5) at screening. * No more than mild TBI according to a modified version of the Brief TBI Screen. * Must not have a medical/neurological problem or use medication that would render MDMA unsafe by history or medical evaluation. * No prior exposure to MDMA. * Are willing to remain overnight at the study site after each experimental session. * Are willing to be driven home the day after the experimental sessions. * Not currently taking any of the listed medications at the time of the study. * Are willing to sign a medical release for the investigators to communicate directly with their therapist and doctors. * Are willing to abstain from alcohol, street drugs, and tobacco products while in the study. Exclusion Criteria: * Patients with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the MINI 7.0 for the DSM-5. * Serious suicide or homicide risk, as assessed by evaluating clinician. * Substance abuse or dependence during the 6 months prior to screening; or a positive pre-study (screening) urine drug screen. * Any significant history of serious medical or neurological illness. * Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory tests (e.g. positive urine tox, positive HIV/AIDS tests ). * Abnormality on physical examination. A participant with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure. * Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day. * Any history indicating learning disability, mental retardation, or attention deficit disorder. * Family history of cardiovascular diseases. History of hypertension with baseline blood pressure above 140 mmHg (systolic) and over 90 mmHg (diastolic). Any history of syncope and/or baseline blood pressure below 100mmHg (systolic). * History of claustrophobia. * BMI \> 30 kg/m2 or \>250 pounds. * Anxiolytic, neuroleptic and SRI medications (off SRIs for 4 weeks, fluoxetine 5 weeks). * Females taking hormonal contraceptives will not be able to participate in the study \*(Hormonal contraceptives are exclusionary because MDMA increases production of oxytocin which is heavily modulated by other hormones (e.g. estrogen). Therefore, women need to be naturally cycling/ovulating and not taking any hormonal medications to participate in this study). * Any metal or electromagnetic implants, including: (Cardiac pacemaker, artificial heart valve, defibrillator, aneurysm clip, cochlear implants, shrapnel, neurostimulators, history of metal fragments in eyes or skin, significant hearing loss or other severe sensory impairment, a history of seizures or current use of anticonvulsants.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Enact Research Collaborative
New Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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