Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442423
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Open-Label Psilocybin Study in Transdiagnostic Population
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Safety Feasibility and Tolerability of Psilocybin Treatment for Individuals with Functional Impairment Related to Mood Anxiety Trauma Andor Addiction Symptoms an Open-label Proof-of-concept Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The primary objective of this study is to investigate the safety feasibility and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements Visit 3 to 1-week Visit 7 4-weeks Visit 8 and 6-weeks Visit 9 post dosing The investigators will recruit individuals with mood anxiety trauma addictive or related symptomatology and who have functional impairment associated with these symptoms A DSM-5 diagnosis is not required nor is it an exclusion The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations Critically this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions
The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg The investigators will also have follow-up visits at 1 4 and 6 weeks and an optional long-term follow-up at 3 6 and 12 months
The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg The investigators will also have follow-up visits at 1 4 and 6 weeks and an optional long-term follow-up at 3 6 and 12 months
Detailed Description:
In this Phase 1b proof-of-concept clinical trial the investigators aim to investigate the safety feasibility and tolerability of treatment of oral psilocybin in participants with functional impairment due to depressive anxiety trauma addictive or other psychiatric symptomatology allowing for comorbidity and diagnostic complexity to mirror potential real-world clinical scenarios Secondarily The investigators will assess improvement in functional status and symptomatology
The investigators will employ an open-label study design with participants receiving one dose of oral psilocybin This is an open-label clinical trial with a single treatment arm and no blinding All participants will receive 25 mg of oral psilocybin All dosing will be accompanied by non-directive support before during and after treatment sessionsThe rationale for conducting this study lies in recognizing that the narrow inclusion and exclusion criteria commonly employed in clinical trials may raise issues of external validity While previous research has predominantly focused on specific diagnostic categories our study aims to address these limitations by exploring the safety feasibility and tolerability of psilocybin in a heterogeneous population
This study also recognizes the importance of symptom-related functional impairment as a cross-cutting construct relevant to all diagnostic categoriesThis is a Phase 1b open-label clinical trial to determine the feasibility tolerability and safety of psilocybin to reduce psychiatric symptoms in participants experiencing functional impairment Participants will receive one dose of oral psilocybin 25mg Follow-up visits for assessments and measures at 1-week 4-week and 6-week post psilocybin dosing Long-term follow-up visits assessments and measures for participants who consent to long-term follow-up reassessments of study measures for 3-month 6-month and 12-month post dosing
Psilocybin 4-hydroxy-NN-dimethyltryptamine occurs in nature in many species of mushrooms including the genera Psilocybe Conocybe Gymnopilus Panaeolus and Strophparia Its chemical formula is C12H17N2O4P Psilocybin is a potent agonist at 5-HT2AC receptors potency of binding by related compounds to these receptors correlates with human potency as hallucinogens Psilocybin is currently a Schedule I substance Psilocybin will be orally administered in this study Psilocybin will be administered in an opaque size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5 The dose of psilocybin will be 25 mg
Descriptives for all safety measures eg C-SSRS total and subscale scores vitals documented adverse events will be compiled at all assessment intervals Classification of adverse events will follow institute and regulatory body guidelines Subsequent summary descriptives may focus on safety indices surrounding the dosing session and 1-week 4 weeks and 6-weeks after dosing In addition The investigators will perform descriptives and non-parametric analysis screen failure rates including analysis of ineligibility drop out rates pre and post dosing to determine feasibility and tolerability
The investigators will employ an open-label study design with participants receiving one dose of oral psilocybin This is an open-label clinical trial with a single treatment arm and no blinding All participants will receive 25 mg of oral psilocybin All dosing will be accompanied by non-directive support before during and after treatment sessionsThe rationale for conducting this study lies in recognizing that the narrow inclusion and exclusion criteria commonly employed in clinical trials may raise issues of external validity While previous research has predominantly focused on specific diagnostic categories our study aims to address these limitations by exploring the safety feasibility and tolerability of psilocybin in a heterogeneous population
This study also recognizes the importance of symptom-related functional impairment as a cross-cutting construct relevant to all diagnostic categoriesThis is a Phase 1b open-label clinical trial to determine the feasibility tolerability and safety of psilocybin to reduce psychiatric symptoms in participants experiencing functional impairment Participants will receive one dose of oral psilocybin 25mg Follow-up visits for assessments and measures at 1-week 4-week and 6-week post psilocybin dosing Long-term follow-up visits assessments and measures for participants who consent to long-term follow-up reassessments of study measures for 3-month 6-month and 12-month post dosing
Psilocybin 4-hydroxy-NN-dimethyltryptamine occurs in nature in many species of mushrooms including the genera Psilocybe Conocybe Gymnopilus Panaeolus and Strophparia Its chemical formula is C12H17N2O4P Psilocybin is a potent agonist at 5-HT2AC receptors potency of binding by related compounds to these receptors correlates with human potency as hallucinogens Psilocybin is currently a Schedule I substance Psilocybin will be orally administered in this study Psilocybin will be administered in an opaque size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5 The dose of psilocybin will be 25 mg
Descriptives for all safety measures eg C-SSRS total and subscale scores vitals documented adverse events will be compiled at all assessment intervals Classification of adverse events will follow institute and regulatory body guidelines Subsequent summary descriptives may focus on safety indices surrounding the dosing session and 1-week 4 weeks and 6-weeks after dosing In addition The investigators will perform descriptives and non-parametric analysis screen failure rates including analysis of ineligibility drop out rates pre and post dosing to determine feasibility and tolerability
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