MDMA Plus Exposure Therapy for PTSD

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05746572
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 13, 2024
Status verified
Jan 2026
Primary completion
May 29, 2026
Completion
May 29, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Medicine Session
    3,4-methylenedioxymethamphetamine (MDMA) in combination with massed exposure therapy for PTSD

Primary Outcome Measure

Effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptoms [ Time Frame: Baseline (day 1) and day 42 (+/- 2 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory Brain Health CenterAtlantaGeorgia30329-

Find similar trials in Atlanta, GA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Emory Brain Health Center· Atlanta, GA

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