Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
Study NCT ID:
NCT06608459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-17
First Post:
2024-09-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
Sponsor:
Filament Health Corp.
Organization:
Study Overview
Official Title:
Open-Label, Single Arm Study of PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to learn if it is feasible to use PEX010 for the treatment of opioid use disorder in adults. The study will also assess the safety of PEX010. The main questions it aims to answer are:
Can we successfully recruit participants, provide the drug and retain participants for the duration of the study?
What medical problems do participants experience when taking PEX010?
Participants will:
Take PEX010 twice during the study Engage in cognitive behavioural therapy Visit the clinic once or twice per week for study intervention and followup visits
Can we successfully recruit participants, provide the drug and retain participants for the duration of the study?
What medical problems do participants experience when taking PEX010?
Participants will:
Take PEX010 twice during the study Engage in cognitive behavioural therapy Visit the clinic once or twice per week for study intervention and followup visits
Detailed Description:
In this open-label study participants will receive PEX010, standardized to contain 25mg or 35 mg psilocybin, in conjunction with therapy. An open-label design was chosen given the novelty of this approach in treating OUD and high risk associated with opioid use.
Following screening and baseline visits, participants will receive 3 preparation sessions with psychotherapy, 2 PEX010 sessions, 2 integration sessions with psychotherapy, and 3 follow-up visits.
Following screening and baseline visits, participants will receive 3 preparation sessions with psychotherapy, 2 PEX010 sessions, 2 integration sessions with psychotherapy, and 3 follow-up visits.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: