MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

This open-label fixed-dose trial (n=10) aims to determine the safety and feasibility of MDMA-assisted psychotherapy (80-120mg) for adolescents with treatment-resistant post-traumatic stress disorder (PTSD).

Sponsored by the University of California, Los Angeles, the study plans to recruit youth aged 16-17 who have continued PTSD diagnosis despite at least 3 months of psychotherapy and/or SSRI pharmacotherapy. The trial involves a 3-month MDMA-assisted psychotherapy course consisting of 13 therapy sessions, including two MDMA experimental medication sessions of 80mg and 120mg, respectively. Participants will undergo baseline assessments, weekly evaluations throughout treatment, and assessments at 3 and 6 months post-treatment.

The primary objective is to assess changes in heart rhythm, blood pressure, pulse, body temperature, and the potential for MDMA misuse.

Secondary objectives include measuring changes in PTSD and depression symptom severity, along with anxiety symptoms.

Recruitment is estimated to start in July 2025, with a completion date anticipated by December 2026.

Topic PTSD Adolescence and Psychedelics Depression Anxiety
Compound MDMA
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 July 2025
End date 31 December 2026
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 10
Sex All
Age 16- 17
Therapy Yes

Trial Details

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

Trial Number NCT06353282

Data attribution

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