Actively Recruiting
MDMA-assisted Massed Prolonged Exposure for PTSD
Led by Healing Breakthrough · Updated on 2026-04-24
20
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
H
Healing Breakthrough
Lead Sponsor
S
San Diego Veterans Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive different doses of MDMA.
CONDITIONS
Official Title
MDMA-assisted Massed Prolonged Exposure for PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be a veteran aged 18 to 64 years old with PTSD severity of 25 or higher on the CAPS-5
- Be fluent in English for speaking and reading
- Willing to commit to medication dosing, therapy sessions, follow-ups, and study evaluations
- Able to swallow pills
- Agree to audio and/or video recording of study visits including MDMA and therapy sessions
- Have a contact able to drive participant home after the MDMA session
- Provide a support contact reachable by investigators if participant becomes suicidal or unreachable
- Agree to inform investigators within 48 hours of any new medical conditions or procedures
- For those who can become pregnant, have a sensitive negative pregnancy test at entry and prior to MDMA session and agree to use effective birth control from 1 month before to 10 days after MDMA session
- Agree to lifestyle modifications including fasting and medication restrictions before and after MDMA session
- Agree not to participate in other PTSD psychotherapy during study treatment
- Not enrolled in other interventional clinical trials during study
- Have at least moderate PTSD symptoms in the last month with a PCL-5 score of 40 or greater
- May have well-controlled hypertension if cardiovascular disease is ruled out
- May have asymptomatic Hepatitis C if previously evaluated and treated
- May have alcohol or substance use disorder if not in withdrawal, with a realistic plan to reduce use and manage symptoms
- May have stable diabetes mellitus (Type 2) with physician approval
- May have hypothyroidism if on stable thyroid medication
- May have history or current glaucoma with ophthalmologist approval
You will not qualify if you...
- Unable to provide written informed consent
- Currently engaged in compensation and pension litigation for PTSD or psychiatric disorders
- Likely to be re-exposed to trauma, lack social support, or stable living situation
- Prior use of Ecstasy or participation in MDMA clinical trials
- Positive screen for amphetamine or cocaine
- Any current problem interfering with safety or ability to participate
- Hypersensitivity to any ingredient of study drug
- Electroconvulsive Therapy within 12 weeks prior to enrollment
- Dementia
- History or current primary psychotic disorder
- History or current Bipolar 1 or 2 disorder or manic episode
- Current eating disorder with active purging
- Current major depressive disorder with psychotic features
- Current panic disorder
- History of amphetamine or cocaine substance use disorder
- Current alcohol or substance use disorder considered a safety concern or interfering with study
- Serious current suicide risk or recent suicidal behavior
- Presenting serious risk to others
- Ongoing psychiatric medication therapy not allowed by study
- Medical condition increasing risk from sympathomimetic drugs such as recent myocardial infarction or aneurysm
- Uncontrolled hypertension
- History of ventricular arrhythmia or serious heart rhythm disorders
- Marked prolongation of QT/QTc interval
- Additional risk factors for Torsade de pointes
- Use of medications prolonging QT/QTc interval during study
- Symptomatic liver disease or repeated significant liver enzyme elevations
- History of hyponatremia or hyperthermia
- Body mass index of 18.5 or less
- Pregnant, nursing, or unwilling/unable to use effective birth control
- Ketamine-assisted therapy or ketamine use within 12 weeks
- Preexisting condition affecting kidney function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Actively Recruiting
Research Team
L
Leslie A Morland, Psy.D.
CONTACT
B
Bettye Chargin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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