A Study of Psilocybin for PTSD (PSI-3PO)

This open-label, controlled study (n=20) will test the feasibility and safety of psilocybin therapy (25mg) for adults with chronic PTSD who are currently taking a serotonin reuptake inhibitor (SSRI).

Conducted by the Johns Hopkins Center for Psychedelic and Consciousness Research, the study aims to determine if psilocybin therapy can significantly alleviate PTSD symptoms and enhance well-being and quality of life.

Participants will be randomised into two groups: one receiving trauma-focused psychotherapy in conjunction with standard psychological support, and the other receiving standard psychological support alone. Both groups will undergo two psilocybin sessions, initially at a dose of 25 mg, with the possibility of increasing to 40 mg based on subjective effects and clinical judgment.

The study will also examine the impact of evidence-based trauma-focused psychotherapy on treatment outcomes. Participants’ PTSD and mood symptoms will be evaluated pre- and post-session, with additional monitoring of subjective drug effects during and after each session.

The study, sponsored by Johns Hopkins University, began in May 2024 and is expected to be completed by May 2027.

Topic PTSD
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 01 May 2024
End date 31 May 2027
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 21- 75
Therapy Yes

Trial Details

The proposed open-label, controlled study at the Johns Hopkins Center for Psychedelic and Consciousness Research (CPCR) will test the following primary hypotheses in adult patients with chronic PTSD who are currently taking a serotonin reuptake inhibitor: psilocybin therapy will be feasible and safe for participants, significantly remediate PTSD symptoms, and enhance wellbeing and quality of life. In addition, the study will examine whether elements of evidence-based trauma-focused psychotherapy enhance treatment response when paired with psilocybin.

NCT Number NCT06407635

Sponsors & Collaborators

Johns Hopkins University
Johns Hopkins University (Medicine) is host to the Center for Psychedelic and Consciousness Research, which is one of the leading research institutes into psychedelics. The center is led by Roland Griffiths and Matthew Johnson.

Data attribution

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