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Psychedelic
MDMA-Assisted Therapy for PTSD (MPVA6 Trial)
Phase 2
Waitlist Available
Led By Rachel Yehuda
Research Sponsored by MAPS Public Benefit Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are at least 18 years old.
Are able to swallow pills.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 4 months from enrollment
Awards & highlights
MPVA6 Trial Summary
This trial will compare the effectiveness of 2 vs 3 sessions of MDMA-assisted therapy in treating PTSD in US military veterans.
Who is the study for?
This trial is for U.S. military veterans aged 18 or older with moderate chronic PTSD. Participants must not be in other trials, able to swallow pills, and fluent in the study site's language. They need a contact person in case of emergencies and agree to recorded sessions and overnight stays post-treatment.Check my eligibility
What is being tested?
The study compares the effectiveness of two versus three active MDMA-assisted psychotherapy sessions for treating PTSD in veterans. It's an open-label, randomized trial where participants will receive either two or three doses of MDMA during therapy at a VA clinic.See study design
What are the potential side effects?
MDMA can cause side effects like anxiety, headache, fatigue, muscle tension, insomnia, nausea, confusion after use (known as 'Tuesday Blues'), mood swings and may increase the risk of suicidal thoughts especially if there's a history of mental health issues.
MPVA6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can swallow pills.
Select...
I have been diagnosed with moderate PTSD.
Select...
I can fluently speak and read the main language used at the study site.
Select...
I can swallow pills.
Select...
I have been diagnosed with moderate PTSD.
Select...
I can fluently speak and read the main language used at the study site.
Select...
I am 18 years old or older.
Select...
I agree to stay overnight at the study site and follow all study procedures.
MPVA6 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline - 4 months from enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 4 months from enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CAPS-5 Total Severity Score from Baseline to Visit 12 for 2 Session Group
Change in CAPS-5 Total Severity Score from Baseline to Visit 16 for 3 Session Group
Secondary outcome measures
Change in Sheehan Disability Scale (SDS) from Baseline to Visit 12 for 2 Session Group
Change in Sheehan Disability Scale (SDS) from Baseline to Visit 16 for 3 Session Group
MPVA6 Trial Design
2Treatment groups
Active Control
Group I: Two sessions of MDMA-assisted therapyActive Control2 Interventions
Two experimental sessions of MDMA-assisted therapy
Group II: Three sessions of MDMA-assisted therapyActive Control2 Interventions
Three experimental sessions of MDMA-assisted therapy
Find a Location
Who is running the clinical trial?
MAPS Public Benefit CorporationLead Sponsor
29 Previous Clinical Trials
1,276 Total Patients Enrolled
Lykos TherapeuticsLead Sponsor
41 Previous Clinical Trials
1,613 Total Patients Enrolled
Multidisciplinary Association for Psychedelic StudiesLead Sponsor
39 Previous Clinical Trials
1,587 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had low sodium levels or very high body temperature in the past.You are not participating in any other interventional clinical trials during the duration of the study.I am 18 years old or older.You have a history of serious medical conditions or currently have a significant medical problem.I have symptoms caused by liver problems.I can swallow pills.I have been diagnosed with moderate PTSD.I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.I can fluently speak and read the main language used at the study site.I can swallow pills.I have been diagnosed with moderate PTSD.I can fluently speak and read the main language used at the study site.I am 18 years old or older.I agree to stay overnight at the study site and follow all study procedures.Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.My high blood pressure is not under control.I weigh less than 48 kg.I am unable to understand or sign the consent form.You agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).
Research Study Groups:
This trial has the following groups:- Group 1: Two sessions of MDMA-assisted therapy
- Group 2: Three sessions of MDMA-assisted therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04784143 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left in the experiment for participants?
"Affirmative. According to the clinicaltrials.gov website, enlistment for this medical trial is still open after its initial posting on November 8th 2021 and subsequent update made on September 13th 2022. For completion of the study, 60 participants will be sought from a single site."
Answered by AI
What is the aggregate number of participants enrolled in this clinical investigation?
"Affirmative. According to the clinicaltrials.gov, this medical trial is currently in recruitment mode and has been since November 8th 2021. The latest update was posted on September 13th 2022 and it requires 60 volunteers from a single location."
Answered by AI
To what extent are Three MDMA-assisted Psychotherapy Sessions potentially harmful to the patient?
"Our team at Power has assigned Three MDMA-assisted Psychotherapy Sessions a safety rating of 2, as this is considered to be in the second phase of clinical trials. Thus far, there are data points that hint towards its security but no evidence supporting efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
New Jersey
Other
New York
How old are they?
18 - 65
What site did they apply to?
James J. Peters VA Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
Why did patients apply to this trial?
Because I need help with my PTSD. I want to explore my treatment options. Interested (within reason) in psychedelics to hear.
PatientReceived no prior treatments
I have tried several things to help me, I have used marijuana and had a decent response to this medicine. I am all about learning and trying different methods.
PatientReceived 1 prior treatment
I have tried a couple of different treatments for PTSD and have never had any relief from it. I am looking for something that is new. I am motivated and looking forward.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Are there any locations closer to my zip code? When would this be available to start? What has the previous tests taught the researchers?
PatientReceived 1 prior treatment
Do I have to be a veteran? Is there any compensation for time and travel? How long is this study? What are the staff looking for as benefits of MDMA?
PatientReceived 1 prior treatment
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