NCT05746572

MDMA Plus Exposure Therapy for PTSD

A Pilot Study of MDMA-Assisted Massed Exposure Therapy for PTSD (MDMA PE)

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Posttraumatic stress disorder (PTSD) is a debilitating disorder. While effective treatments exist, some patients fail to receive the full benefits. Alternative treatment approaches are needed. 3,4-methylenedioxymethamphetamine (MDMA) is a medicine associated with feelings of closeness and love for others, empathy, insightfulness, and feelings of peace or well-being. Recent research combining one or two doses of MDMA with psychotherapy has shown improvements in PTSD symptoms. For the present study, the researchers will investigate MDMA in combination with Prolonged Exposure therapy (PE), a gold-standard treatment for PTSD. All participants receive MDMA on the second day of a 10-day PE treatment program in which a PE therapy session occurs each day. This study will occur at the Emory Brain Health Center. Potential participants will be recruited via community advertising and mental health referrals. The research team will also collect psychophysiological data for exploratory analyses regarding how MDMA may improve PE treatment for PTSD. This is an important study as it is the first time MDMA will be combined with an evidence-based existing PTSD treatment. The study population will consist of people who meet the criteria for PTSD and are medically appropriate for MDMA administration.

Detailed description

Exposure-based interventions for PTSD have strong empirical support and involve helping PTSD patients confront feared trauma-related memories and triggers in a therapeutic manner so that distress decreases. This study will involve massed exposure therapy, which involves daily therapy sessions for two weeks, in combination with a one-time administration of MDMA. This is an open-label trial in which all enrolled participants will receive MDMA administration during treatment. An initial phone screen will be conducted for interested individuals to describe the study and assess eligibility. Following the phone screen, informed consent will occur. Interested individuals will also complete a drug test in their local community to be reviewed by the study team. For individuals interested in tapering their psychiatric medication, this may be done with a local provider or study physician. In this event, a psychiatric assessment will be conducted at the end of medication tapering to reassess eligibility. For those who choose to participate and are eligible, the first day will involve a medical and psychiatric assessment to confirm eligibility, a blood draw to check medical labs, a psychophysiological assessment, completing self-report measures, and one therapy session. Additionally, an optional fMRI scan will be offered at a pre-treatment visit and an end-of-treatment visit. Upon confirmation of eligibility, the second day (or Medicine session) will involve MDMA administration followed by two therapy sessions with a break in between. A psychophysiological session will also occur on Day 2. Days 3-10 (which do not involve drug administration) will include a daily exposure therapy session. Psychophysiology will be collected during the therapy session. A psychophysiology session will occur on Days 4, 9, and 10 in addition to Days 1 and 2. Participants will be contacted at one week, two weeks, four weeks, and 6 months after treatment ends to complete symptom assessments via phone or online measures.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	MDMA	Participants will receive MDMA HCl (100 mg, 84 mg MDMA) in combination with massed exposure therapy for PTSD.

Timeline

• Start date: 2024-02-13
• Primary completion: 2026-05-29
• Completion: 2026-05-29
• First posted: 2023-02-27
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study