MDMA-Assisted Massed Exposure Therapy for PTSD

ConditionPost Traumatic Stress Disorder

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age21-70

SponsorEmory University

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

3,4-Methylenedioxymethamphetamine (MDMA)
Placebo
Massed Prolonged Exposure (PE)

Treatment groups

200 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov