Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615908
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Treatment of Persistent Post-concussive Symptoms With Psilocybin Assisted Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double Blinded Controlled Trial for the Treatment of Persistent Post-concussion Symptoms With Psilocybin Assisted Therapy A Safety and Feasibility Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PatACT
Brief Summary:
The goal of this randomized controlled trial is to evaluate the safety feasibility and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients aged 18-65 with persistent post-concussion symptoms PPCS
This trail will test the following 2 aims
AIM 1 To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PPCS
AIM 2 To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PPCS
Participants will be asked to
Complete a 2 part screening process
Attend a baseline assessment
Complete a psychoeducation preparation sessions
Attend psilocybin administration session receive high dose 25mg or low dose psilocybin 1mg
Complete 5-6 weekly sessions of BrainACT
Repeat outcome measures at 1-week 4 weeks 3 months and 6 months post-psilocybin administration online only at 6 months
This trail will test the following 2 aims
AIM 1 To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PPCS
AIM 2 To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PPCS
Participants will be asked to
Complete a 2 part screening process
Attend a baseline assessment
Complete a psychoeducation preparation sessions
Attend psilocybin administration session receive high dose 25mg or low dose psilocybin 1mg
Complete 5-6 weekly sessions of BrainACT
Repeat outcome measures at 1-week 4 weeks 3 months and 6 months post-psilocybin administration online only at 6 months
Detailed Description:
The overall objective of this study is to evaluate the safety feasibility and efficacy of psilocybin assisted therapy administered with Acceptance and Commitment Therapy ACT modified to the needs of people with acquired injury BrainACT as an intervention to reduce symptom burden in patients with persistent post-concussion symptoms PPCS
This trail will test the following 2 aims
AIM 1 To test the safety and feasibility of an activehigh dose 25mg psilocybin-assisted psychotherapy to an active control 1mg for adults with PPCS Safety will be determined through the reporting of adverse events and response following psilocybin for each participant up to 6-months Feasibility will be determined through recruitment enrollment and adherence rates
AIM 2 To evaluate the efficacy of an activehigh dose 25mg psilocybin-assisted psychotherapy compared to an active control 1mg as a treatment for PPCS at 1-week 4 weeks 3 months and 6 months post-psilocybin administration The primary efficacy outcome will be the change in PPCS burden RPQ
The secondary efficacy outcomes will include measures of headache dizziness mood anxiety post-traumatic stress cognitive flexibility emotional regulation and quality of life
A total of 40 male and female patients between the ages of 18-65 with a diagnosis of mild traumatic brain injury American College of Rehabilitation Medicine 2023 criteria who meet criteria for persistent post-concussion symptoms ICD-10 within 3 months to 5 years will be recruited from Calgary brain injury clinics and the community
All patients will undergo a thorough 2-part screening procedure Eligible participants will be randomly allocated 11 to either the high dose 20 participants or low dose 20 participants psilocybin groups All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session Following the single dosing session participants will complete 5-6 weekly BrainACT sessions Outcome measure assessments will be repeated at 1-week 4 weeks 3 months and 6 months post-dosing
This trail will test the following 2 aims
AIM 1 To test the safety and feasibility of an activehigh dose 25mg psilocybin-assisted psychotherapy to an active control 1mg for adults with PPCS Safety will be determined through the reporting of adverse events and response following psilocybin for each participant up to 6-months Feasibility will be determined through recruitment enrollment and adherence rates
AIM 2 To evaluate the efficacy of an activehigh dose 25mg psilocybin-assisted psychotherapy compared to an active control 1mg as a treatment for PPCS at 1-week 4 weeks 3 months and 6 months post-psilocybin administration The primary efficacy outcome will be the change in PPCS burden RPQ
The secondary efficacy outcomes will include measures of headache dizziness mood anxiety post-traumatic stress cognitive flexibility emotional regulation and quality of life
A total of 40 male and female patients between the ages of 18-65 with a diagnosis of mild traumatic brain injury American College of Rehabilitation Medicine 2023 criteria who meet criteria for persistent post-concussion symptoms ICD-10 within 3 months to 5 years will be recruited from Calgary brain injury clinics and the community
All patients will undergo a thorough 2-part screening procedure Eligible participants will be randomly allocated 11 to either the high dose 20 participants or low dose 20 participants psilocybin groups All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session Following the single dosing session participants will complete 5-6 weekly BrainACT sessions Outcome measure assessments will be repeated at 1-week 4 weeks 3 months and 6 months post-dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None