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ACTIVE NOT RECRUITING
NCT06407635
PHASE1

A Study of Psilocybin for PTSD

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

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.

Official title: Psilocybin for PTSD With or Without Psychotherapy: A Pilot Study of Safety and Efficacy

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-06-07

Completion Date

2027-05

Last Updated

2025-10-31

Healthy Volunteers

No

Interventions

DRUG

Psilocybin

The two psilocybin doses will be administered approximately 2 weeks apart in the form of an oral capsule. The first dose will be 25mg. For the second dosing session, participants will either remain on 25 mg of psilocybin, or will receive a dose of 40 mg, depending on the strength of subjective effects experienced during the first dosing session, as well as clinical judgment and participant preference.

OTHER

Trauma-focused psychotherapy

Components of trauma-focused psychotherapy will include Cognitive Processing Therapy and in vivo exposure. Such components of evidence-based psychotherapy may lower the safety risk profile for this vulnerable population and enhance the effect size and maintenance of psilocybin therapy.

OTHER

Standard psychological support

Standard psychological support involves providing a safe and emotionally supportive environment to participants throughout the course of their participation, and being attentive and responsive to their emotional needs. It includes continued review and discussion of experiences that participants encountered during the psilocybin sessions and the way that those experience relate to the participant's life and clinical status.

Locations (1)

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States