Phase 2 PTSD Trial, Recruiting NCT05837845 Sponsor: Patricia Suppes Condition: PTSD
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Phase 2 PTSD Trial, Recruiting

NCT05837845
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are at least 18 years old at the time of signing the consent form
  • People who are U.S. Military Veterans
  • People who are currently receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
  • People who can speak and read English fluently
  • People who agree to have their study visits recorded by audio and/or video
  • People assigned to the MDMA-assisted therapy group who are able to identify suitable support person(s) to stay with them on the evenings of MDMA sessions
  • People who meet the clinical diagnostic criteria for PTSD (post-traumatic stress disorder) with symptoms lasting at least 6 months
  • People who have had severe PTSD symptoms in the past month
  • People who weigh at least 48 kilograms (approximately 106 pounds)
  • People who are not pregnant, not planning to become pregnant, and not breastfeeding
  • People who are able to give informed consent to participate

Who may not be able to join:

  • People with a history of certain medical conditions that could make receiving a type of drug called a sympathomimetic (a stimulant-type medication) harmful to them (confirm with trial site)
  • People with a current unstable medical illness
  • People with heart-related conditions, including uncontrolled high blood pressure, certain irregular heart rhythms, or other heart conditions
  • People who have received electroconvulsive therapy (ECT), ketamine-assisted therapy, or have used ketamine within the 12 weeks before enrolling
  • People with moderate or severe alcohol or cannabis use disorder within the past 12 months
  • People with any level of active substance use disorder involving illicit drugs (other than cannabis) or misuse of prescription drugs within the past 12 months
  • People who are currently at serious risk of suicide
  • People who are unable or unwilling to stop or safely reduce certain medications that are not permitted during the trial
  • People who have ever used MDMA (also known as ecstasy) at any point in their life
  • People who are currently enrolled in another clinical study
  • People with a personal history of a primary psychotic disorder, Type I bipolar disorder, severe personality disorder, an eating disorder involving compensatory behaviours, or a depressive disorder with psychotic features
  • People who lack social support or a stable living situation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Trisha Suppes, MD, PhD, VA Palo Alto Healthcare System / Stanford University

Phone: 650-849-0161

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Patricia Suppes
Registry
ClinicalTrials.gov
Start date
10 February 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov