A Study of Psilocybin for PTSD

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 7, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
Post Traumatic Stress Disorder
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.

Trial Locations (1)

21224

RECRUITING

Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

All Listed Sponsors
collaborator

Steven & Alexandra Cohen Foundation

OTHER

collaborator

Usona Institute

OTHER

lead

Johns Hopkins University

OTHER