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A Study of Psilocybin for PTSD
Sponsor: Johns Hopkins University
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
Conditions
Interventions
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.
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.
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