Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT07288151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MDMA-Assisted Massed Exposure Therapy for PTSD
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
MDMA-Assisted Massed Exposure Therapy for PTSD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants.
The main questions it aims to answer are:
* Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo?
* Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo?
* Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes?
Participants will:
* Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks
* Be administered either 100 mg of MDMA or a placebo at Visit 2
* Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up
The main questions it aims to answer are:
* Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo?
* Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo?
* Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes?
Participants will:
* Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks
* Be administered either 100 mg of MDMA or a placebo at Visit 2
* Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up
Detailed Description:
Posttraumatic stress disorder (PTSD) affects many individuals, including military veterans and civilians exposed to trauma. While trauma-focused therapies like Prolonged Exposure (PE) are effective, many people do not fully recover, and current medications often have limited success.
This study will test whether combining PE therapy with a single dose of MDMA (a psychoactive drug) can improve PTSD treatment outcomes. Ninety-five participants with PTSD will be randomly assigned to receive either MDMA or a placebo during the second of ten PE therapy sessions, which are delivered over two weeks. Researchers will measure PTSD symptoms one month after treatment using a standardized interview.
The study will also explore how MDMA affects brain responses related to fear and emotional memory, which may help explain how it works. Early results from a pilot study suggest this combination may lead to large reductions in PTSD symptoms. This is the first clinical trial to formally test MDMA with PE therapy, and it may lead to new, more effective treatment options for PTSD.
This study will test whether combining PE therapy with a single dose of MDMA (a psychoactive drug) can improve PTSD treatment outcomes. Ninety-five participants with PTSD will be randomly assigned to receive either MDMA or a placebo during the second of ten PE therapy sessions, which are delivered over two weeks. Researchers will measure PTSD symptoms one month after treatment using a standardized interview.
The study will also explore how MDMA affects brain responses related to fear and emotional memory, which may help explain how it works. Early results from a pilot study suggest this combination may lead to large reductions in PTSD symptoms. This is the first clinical trial to formally test MDMA with PE therapy, and it may lead to new, more effective treatment options for PTSD.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TP240376 | OTHER | DOD | View |