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MDMA-Assisted Exposure Therapy for PTSD

Phase 4
Recruiting
Led By Jessica Maples-Keller, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and day 42 (+/- 2 days)
Awards & highlights

Study Summary

This trial is researching if combining MDMA with an evidence-based PTSD treatment improves outcomes. It will occur at the Emory Brain Health Center with potential participants recruited via community advertising and mental health referrals.

Who is the study for?
This trial is for individuals with PTSD who can swallow pills, have a support contact, and agree to lifestyle changes including fasting and avoiding certain medications. Women must test negative for pregnancy and use birth control. Participants cannot be in other clinical trials or have conditions that MDMA exacerbates, like uncontrolled hypertension or heart issues.Check my eligibility
What is being tested?
The study tests the combination of MDMA with Prolonged Exposure therapy for treating PTSD over a 10-day program at Emory Brain Health Center. All participants receive MDMA on day two alongside daily PE sessions. The aim is to see if MDMA enhances the standard treatment's effectiveness.See study design
What are the potential side effects?
MDMA may cause increased blood pressure and heart rate, which could be risky for those with certain medical conditions. Other potential side effects include feelings of empathy and well-being but also risks associated with psychoactive substances such as altered sensory perception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and day 42 (+/- 2 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and day 42 (+/- 2 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptoms
Secondary outcome measures
Effect of MDMA on massed exposure therapy on self-reported PTSD symptoms.

Side effects data

From 2018 Phase 1 & 2 trial • 12 Patients • NCT02876172
33%
Anxiety
17%
Nasal congestion
17%
Rash
17%
Dyspnoea
17%
Visual Impairment
17%
Vomiting
17%
Upper respiratory tract infection
17%
Arthropod bite
17%
Disturbance in attention
17%
Paresthesia
17%
Oropharyngeal pain
17%
Pruritis
17%
Dizziness
17%
Insomnia
17%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
CSO Patients at 6-month Follow-up
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

1Treatment groups
Experimental Treatment
Group I: Medicine SessionExperimental Treatment1 Intervention
3,4-methylenedioxymethamphetamine (MDMA) in combination with massed exposure therapy for PTSD
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?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,617 Total Patients Enrolled
Jessica Maples-Keller, PhDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
23 Total Patients Enrolled
Barbara O Rothbaum, PhDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
89 Total Patients Enrolled

Media Library

MDMA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05746572 — Phase 4
Post-Traumatic Stress Disorder Research Study Groups: Medicine Session
Post-Traumatic Stress Disorder Clinical Trial 2023: MDMA Highlights & Side Effects. Trial Name: NCT05746572 — Phase 4
MDMA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746572 — Phase 4

Frequently Asked Questions

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

Is the age limit for participating in this clinical trial set at 25 or above?

"This trail seeks applicants aged between 21 and 70 years of age."

Answered by AI

Am I a suitable candidate for participating in this evaluation?

"To qualify for this trial, applicants must have PTSD and should be between 21 and 70 years old. A total of 40 individuals will be accepted into the study."

Answered by AI

What risks do individuals face when undergoing Medicine Session therapy?

"This therapy has been approved and is thus perceived to have a high level of safety, earning it a rating of 3."

Answered by AI

Are individuals able to sign up for this trial at the present time?

"Per the information posted on clinicaltrials.gov, this experiment is no longer actively searching for participants. The trial was initially announced on February 1st 2023 and its last edit occurred a fortnight later. However, there are 307 other trials currently enlisting patients at present."

Answered by AI

Who else is applying?

What site did they apply to?
Emory Brain Health Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
MDMA Plus Exposure Therapy for PTSD
Jessica Maples-Keller 2024. "MDMA Plus Exposure Therapy for PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746572.
~27 spots leftby Dec 2025
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