Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206265
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-09-12
Brief Title:
Assessment of Psilocybin TRP-8802 in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome IBS
Sponsor:
TRYP Therapeutics
Organization:
TRYP Therapeutics
Study Overview
Official Title:
A Phase 2a Open-label Pilot Study to Assess the Safety and Efficacy of Oral Psilocybin TRP-8802 Administration in Concert With Psychotherapy Among Adult Patients With Irritable Bowel Syndrome A Randomized Delayed Treatment Control Design
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Participants with IBS all subtypes and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study
This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants with IBS The study will include clinician and participant ratings of depression and anxiety pre- and post-drug-session monitor and participant ratings of subjective drug effects during and after each drug session
This study comprises approximately a 28-day screening period Days 28 to 1 After screening and enrollment participants will be randomized to an immediate treatment group or a delayed treatment group waitlist control condition
Participants in the immediate treatment group will proceed directly into three weeks of baseline and preparation Days 1 to 18 a 2-dose administration period Days 22 and 37 integration Days 23 30 38 and 45 the End of Therapy EOT visit Day 52 Participants in the delayed treatment group will wait 8 weeks after enrollment before beginning the study interventions and neuroimaging assessments As a safety precaution participants in the delayed treatment group will be assessed weekly via telephone calls or in-person visits during the wait period ie telephone assessments during post-randomization weeks 1 2 3 4 5 6 and 7 in-person assessment during post-randomization week 8 to assess suicide risk to determine if intervention is warranted During week 8 IBS symptoms will also be assessed At the end of the delay period all participants in the delayed treatment group will complete the same intervention as the participants in the immediate treatment group
Validated and commonly used assessment tools will be used to evaluate symptoms at baseline and repeatedly after each session The weekly average of worst daily pain score and weekly stool frequency and consistency for the 7 days immediately prior to EOT visit will be assessed for change from baseline and at the 3- 6 and 12- month follow-up visits Days 120 240 365
This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants with IBS The study will include clinician and participant ratings of depression and anxiety pre- and post-drug-session monitor and participant ratings of subjective drug effects during and after each drug session
This study comprises approximately a 28-day screening period Days 28 to 1 After screening and enrollment participants will be randomized to an immediate treatment group or a delayed treatment group waitlist control condition
Participants in the immediate treatment group will proceed directly into three weeks of baseline and preparation Days 1 to 18 a 2-dose administration period Days 22 and 37 integration Days 23 30 38 and 45 the End of Therapy EOT visit Day 52 Participants in the delayed treatment group will wait 8 weeks after enrollment before beginning the study interventions and neuroimaging assessments As a safety precaution participants in the delayed treatment group will be assessed weekly via telephone calls or in-person visits during the wait period ie telephone assessments during post-randomization weeks 1 2 3 4 5 6 and 7 in-person assessment during post-randomization week 8 to assess suicide risk to determine if intervention is warranted During week 8 IBS symptoms will also be assessed At the end of the delay period all participants in the delayed treatment group will complete the same intervention as the participants in the immediate treatment group
Validated and commonly used assessment tools will be used to evaluate symptoms at baseline and repeatedly after each session The weekly average of worst daily pain score and weekly stool frequency and consistency for the 7 days immediately prior to EOT visit will be assessed for change from baseline and at the 3- 6 and 12- month follow-up visits Days 120 240 365
Detailed Description:
None
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