Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05995769
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-08-09
Brief Title:
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-08
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:
PAP-AUD
Brief Summary:
The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy MET can reduce heavy drinking in patients with an alcohol use disorder AUD
Detailed Description:
The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention motivational enhancement therapy MET can reduce heavy drinking in a patient population with an alcohol use disorder AUD Patients with an AUD will be randomly allocated to either a high dose 25mg active treatment or a low dose 1mg active control psilocybin arm All participants will receive 5 sessions of MET starting at 24hrs post-dosing Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back TLFB at baseline and 1- 4- and 12-weeks post-dosing
A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high N64 or low N64 psilocybin doses All participants will complete a baseline session consisting of clinical behavioral and neuroimaging measures Following the single dosing session participants will complete 5 weekly MET sessions Neuroimaging measures will be assessed again at 1-week post-doing Clinical and behavioral outcomes will be measured at 1- 4- and 12-weeks post-dosing
A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high N64 or low N64 psilocybin doses All participants will complete a baseline session consisting of clinical behavioral and neuroimaging measures Following the single dosing session participants will complete 5 weekly MET sessions Neuroimaging measures will be assessed again at 1-week post-doing Clinical and behavioral outcomes will be measured at 1- 4- and 12-weeks post-dosing
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?:
False
Is an FDA AA801 Violation?:
None