Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-18
Brief Title:
Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder An Open-label Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
This is an open-label trial evaluating feasibility tolerability safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder PTSD
Detailed Description:
Current front-line treatments for Posttraumatic stress disorder PTSD are ineffective for up to half of patients with serious medical and societal consequences It is imperative to improve the efficacy of front-line treatment options such as cognitive processing therapy CPT CPT is an effective treatment for PTSD including when delivered intensively ie multiple sessions over 7 days However a substantial proportion of patients continue to meet criteria for PTSD or have residual PTSD symptoms post-treatment Psilocybin-assisted CPT may be a potential solution as preliminary evidence supports the potential of psilocybin to alleviate symptoms of PTSD
Fifteen participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT and 2 psychotherapy sessions related to psilocybin over 7 days Participants will complete clinician-administered scales self-reported mental health questionnaires and use a wearable device After the 1-week interventional period participants will enter a 12-weeks follow-up period
Fifteen participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT and 2 psychotherapy sessions related to psilocybin over 7 days Participants will complete clinician-administered scales self-reported mental health questionnaires and use a wearable device After the 1-week interventional period participants will enter a 12-weeks follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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