No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Patricia Suppes · Other
Who this trial is looking for
This trial is looking for U.S. military veterans with severe PTSD. Participants will receive either MDMA-assisted therapy or standard therapy for PTSD and will need to attend study visits.
Are You a Good Fit for This Trial?
You may be able to join if
I am a U.S. Military Veteran
I am at least 18 years old
I can read and speak English
I agree to have study visits recorded
I have been diagnosed with PTSD for at least 6 months
I have severe PTSD symptoms in the last month
I weigh at least 48 kilograms
I am not pregnant or breastfeeding
You may not be able to join if
I have a medical condition that makes sympathomimetic drugs harmful
I have a current unstable medical illness
I have any cardiac conditions
I have used ketamine or received ECT in the last 12 weeks
I have moderate or severe alcohol use disorder in the last 12 months
I have current serious suicide risk
I have a personal history of serious mental health disorders
I lack social support or a stable living situation
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT versus Cognitive Processing Therapy …
In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-aCPT for PTSD within the VA system.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Are at least 18 years at the time of signing the informed consent
2. Are a U.S Military Veteran
3. Are receiving services from VA Palo Alto Healthcare System, VA San Francisco …
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Are at least 18 years at the time of signing the informed consent
2. Are a U.S Military Veteran
3. Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
4. Are fluent in speaking and reading in English
5. Agree to have study visits audio and/or video recorded
6. If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions
7. Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months
8. Have severe PTSD symptoms in the last month
9. Body weight of at least 48 kilograms (kg)
10. Is not pregnant, planning to get pregnant, or breastfeeding
11. Capable of giving signed informed consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
1. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful
2. Have current unstable medical illness
3. Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
4. Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
5. Moderate or severe alcohol or cannabis use disorder within the last 12 months
6. Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months
7. Have current serious suicide risk
8. Unable or unwilling to stop or safely taper off prohibited medications
9. Have used MDMA (ecstasy) ever
10. Currently enrolled in any clinical study
11. Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features
12. Lack social support, or lack a stable living situation
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