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Post Traumatic Stress DisorderPTSD and traumaPsychedelicsBehavioralDrugBehavioralPhase 2

What this study is

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

What's being tested

  • 3,4-Methylenedioxymethamphetamine (MDMA)

    Intervention · DRUG

    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

  • Placebo

    Intervention · DRUG

    Placebos will visually match the 3 MDMA capsules (40mg, 40mg, and 20mg).

  • Massed Prolonged Exposure (PE)

    Intervention · BEHAVIORAL

    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 details

Sponsor
Emory University
Conditions
Post Traumatic Stress Disorder
Enrolling
200 people
Starts
2026-07
Est. completion
2030-01
Design
Triple-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗