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MDMA for PTSD

Phase 1
Waitlist Available
Led By Benjamin Kelmendi, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have a medical/neurological problem or use medication that would render MDMA unsafe by history or medical evaluation.
No prior exposure to MDMA.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, initial and second drug dose, 24 hours after initial and second drug dose, 1 week after initial and second drug dose.
Awards & highlights

Study Summary

This trial will study how MDMA affects the brain of people with PTSD, in hopes of finding a better way to treat the disorder.

Who is the study for?
Adults aged 21-55 with PTSD, able to consent and communicate in English. Participants must not be pregnant, agree to birth control if applicable, have no severe medical issues or history of substance abuse, and cannot be on certain medications. They should score at least 23 on the PTSD scale without a significant past exposure to MDMA.Check my eligibility
What is being tested?
The trial is examining how MDMA affects brain activity in areas linked to emotions and behavior in people with PTSD. It compares these effects against Niacin as a control. Participants will stay overnight post-session for monitoring.See study design
What are the potential side effects?
MDMA may cause anxiety, mood changes, sleep disturbances, appetite loss, physical discomfort like muscle tension or nausea, and potential risks related to heart rate and blood pressure changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have any health issues or take medications that make MDMA unsafe for me.
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I have never used MDMA.
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I am between 21-55 years old, not pregnant, and use or agree to use certain birth control methods or am unable to have children.
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I have never used MDMA.
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I have had a mild traumatic brain injury.
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I have been diagnosed with PTSD by a professional.
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I agree to have someone drive me home after the sessions.
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I have had a mild traumatic brain injury.
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I don't have health issues or take medications that make MDMA unsafe for me.
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I am not taking any medications listed for the study.
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I am between 21 and 55 years old.
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I have been diagnosed with PTSD by a professional.
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I have been diagnosed with PTSD by a professional.
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I am not taking any of the medications listed for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24 hours after initial and second drug dose, 3 and 5 days after initial and second drug dose (phone), 1 week after initial and second drug dose, 15, 17, 19, and 21 days after second drug dose (phone).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24 hours after initial and second drug dose, 3 and 5 days after initial and second drug dose (phone), 1 week after initial and second drug dose, 15, 17, 19, and 21 days after second drug dose (phone). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in activation of mPFC, amygdala, and nucleus accumbens upon presentation of emotional faces.
Secondary outcome measures
Brain injury will be assessed for with the CogState Neuropsychological Test
Changes in PTSD symptoms, which will be measured by The Clinician-Administered PTSD Scale 5 (CAPS-5).
Changes in PTSD symptoms, which will be measured by The Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5).
+14 more

Side effects data

From 2018 Phase 1 & 2 trial • 12 Patients • NCT02876172
17%
Abortion, spontaneous
17%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSO Patients at 6-month Follow-up
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
PTSD Patients at 6-month Follow-up
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MDMAExperimental Treatment1 Intervention
MDMA (1.5mg/kg)
Group II: NiacinPlacebo Group1 Intervention
Niacin (250mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MDMA
2001
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,393 Total Patients Enrolled
Benjamin Kelmendi, MDPrincipal Investigator - Yale University
Yale University
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

MDMA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03752918 — Phase 1
Post-Traumatic Stress Disorder Research Study Groups: MDMA, Niacin
Post-Traumatic Stress Disorder Clinical Trial 2023: MDMA Highlights & Side Effects. Trial Name: NCT03752918 — Phase 1
MDMA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03752918 — Phase 1
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT03752918 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental study open to geriatric patients?

"For admittance into this clinical trial, the age range must be between 21 and 55. There are 46 studies aimed at those younger than 18 years old, while 345 studies target those over 65."

Answered by AI

Are there any past experiments that looked into the therapeutic advantages of MDMA?

"Presently, there are 19 separate clinical trials for the use of MDMA. One is currently in Phase 3 and 35 locations across the country have studies running. The highest concentration of these tests can be found in Knoxville, TN."

Answered by AI

Has the FDA sanctioned MDMA for medicinal use?

"Our Power team gauged MDMA's safety at a 1, as this is an early Phase 1 trial which only has scant evidence of its effectiveness and security."

Answered by AI

What has been the traditional application of MDMA?

"MDMA is often used to reduce the risk of cardiovascular illness. It also may be effective for managing dyslipidemias, pancreatitis and lipidemia."

Answered by AI

How many applicants are being considered for participation in this research endeavor?

"Affirmative, clinicaltrials.gov indicates that this trial is presently recruiting participants. It was originally posted on January 15th 2023 and most recently updated on October 20th 2022, aiming to secure participation from 20 individuals at a single medical centre."

Answered by AI

Are there still places available to be a participant in this experiment?

"Based on the clinicaltrials.gov listing, this clinical trial is actively recruiting participants. It initially appeared online on January 15th 2023 and was last updated October 20th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
Utah
Connecticut
How old are they?
18 - 65
What site did they apply to?
Connecticut Mental Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am a disabled veteran who suffers with ptsd and I'd like to try and help myself and others.
PatientReceived 1 prior treatment
I've tried lots of meds and they don't help and I have poured my heart out in therapy for 20 years! My PTSD originated because of abuse of all kinds! Then 7 years ago I got in a car accident and I'm to afraid to drive!! I have my mother drive me where I have to go!! For the most part I'm agoraphobic and only leave the house for therapy!! I really would like my life back and I hope you will help me!
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How many weeks does this take and what exactly do you need to know from me?
PatientReceived 1 prior treatment
~13 spots leftby Jan 2028