Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407635
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-06
Brief Title:
A Study of Psilocybin for PTSD
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Psilocybin for PTSD With or Without Psychotherapy A Pilot Study of Safety and Efficacy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSI-3PO
Brief 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
Detailed Description:
This study uses a randomized controlled design to compare the safety and efficacy of 2 doses of psilocybin for PTSD In addition it will investigate the effects of trauma-focused psychotherapy which includes standard psychological support versus standard psychological support alone Twenty participants will be recruited Following the first psilocybin session participants will be randomized to either the trauma-focused psychotherapy which includes standard psychological support treatment condition or the standard psychological support treatment condition the latter being typical for the experimental administration of psilocybin therapy Both groups will receive identical treatment prior to receiving the first dose of psilocybin with one group receiving procedures related to trauma-focused psychotherapy combined with standard psychological support beginning after receipt of psilocybin The study will include clinician and participant ratings of PTSD and mood symptoms pre- and post-drug session and monitor and participant ratings of subjective drug effects during and after each drug session
The intervention for both groups will consist of about 8 hours of preparatory meetings over approximately 2 weeks followed by 2 psilocybin sessions separated by approximately 2 weeks The initial psilocybin dose will be 25 mg The dose for the second session may be increased conditional on the strength of subjective effects as measured by the Mystical Experiences Questionnaire MEQ30 taken at the end of participants first psilocybin session This allows a dose to increase if for example concomitant serotonin reuptake inhibitors reduce subjective effects Participants with a score 60 of the maximum on the MEQ30 will remain at a dose of 25 mg of psilocybin for the second session Participants with an MEQ30 score below 60 will receive a dose of 40 mg for the second session Elevation of dose will also be based on the clinical judgment of the principal investigator study physician and study staff that a higher dose can be safely administered In addition participants who prefer to not elevate the dose will remain at 25 mg for the second session
To support the participants therapeutic integration of psilocybin experiences following each psilocybin session participants will meet with the session facilitators at multiple scheduled time points Additional contact hours will be scheduled if it is judged that the participant would benefit from additional meetings to discuss experiences from the sessions or to prepare for the next session
The intervention for both groups will consist of about 8 hours of preparatory meetings over approximately 2 weeks followed by 2 psilocybin sessions separated by approximately 2 weeks The initial psilocybin dose will be 25 mg The dose for the second session may be increased conditional on the strength of subjective effects as measured by the Mystical Experiences Questionnaire MEQ30 taken at the end of participants first psilocybin session This allows a dose to increase if for example concomitant serotonin reuptake inhibitors reduce subjective effects Participants with a score 60 of the maximum on the MEQ30 will remain at a dose of 25 mg of psilocybin for the second session Participants with an MEQ30 score below 60 will receive a dose of 40 mg for the second session Elevation of dose will also be based on the clinical judgment of the principal investigator study physician and study staff that a higher dose can be safely administered In addition participants who prefer to not elevate the dose will remain at 25 mg for the second session
To support the participants therapeutic integration of psilocybin experiences following each psilocybin session participants will meet with the session facilitators at multiple scheduled time points Additional contact hours will be scheduled if it is judged that the participant would benefit from additional meetings to discuss experiences from the sessions or to prepare for the next session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None