The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD.

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder

In brief

This study aims to investigate the effects of MDMA on prefrontal and amygdala activation, and to explore the relationship between these MDMA-induced neural changes and the acute behavioral effects of the drug in patients with PTSD.

Key facts

Study ID

NCT03752918

Run by

Yale University

People needed

0

Starts

2024-05-01

Expected to finish

2028-01-01

Last updated by the study team

2026-05-19

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Enact Research Collaborative — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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