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MDMA Plus Exposure Therapy for PTSD

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary and study completion pushed from May 29, 2026 to Oct 31, 2026 Study description expanded, about 3 wordsv11 Show 1 more changeShow less
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Trial status: Recruiting to Enrolling by Invitation Primary and study completion dates: Dec 2025 to May 29, 2026 · Site details revisedv10 Show 2 more changesShow less
    • Primary and study completion dates: Dec 2025 to May 29, 2026
    • Site details revised
  3. Minor Study description expanded, about 18 wordsv9 See this version in full on ClinicalTrials.gov ↗
  4. Notable Phase: Phase 4 to Phase 2v8
  5. Minor Start date changed from estimate of Jan 2024 to Feb 13, 2024v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Dec 2023 to Jan 2024 · Site details revisedv6 Show 2 more changesShow less
    • Start date: Dec 2023 to Jan 2024
    • Site details revised
  2. Notable Start date: Sep 2023 to Dec 2023v5
  3. Notable Start date: Jun 2023 to Sep 2023v4
  4. Minor Start date: May 2023 to Jun 2023v3
  5. Notable Start date: Feb 2023 to May 2023 Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
821 trials monitored
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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.
Trial Details
NCT Number NCT05746572
Lead Sponsor Emory University
Conditions PTSD
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov