Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-30
Brief Title:
Psilocybin-assisted Therapy for Alcohol Use Disorder
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
A Multi-centre Double-blinded Placebo-controlled Randomised Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind randomised phase II clinical trial
Detailed Description:
New strategies for treating Alcohol Use Disorder AUD are urgently needed Recent evidence has shown promising results for psychedelic-assisted therapies particularly psilocybin which has demonstrated efficacy in reducing alcohol consumption and improving psychological well-being This study aims to evaluate the clinical efficacy and tolerability of psilocybin-assisted therapy compared to a control niacin in reducing heavy drinking days HDD per week among individuals with AUD
Primary Objective
To conduct a double-blind randomised controlled trial with 90 participants diagnosed with Alcohol Use Disorder AUD The primary aim is to compare the efficacy of psilocybin-assisted therapy two sessions of psilocybin 25 mg per dosing session versus control niacin 250mg and therapy in reducing alcohol consumption specifically measuring the number of heavy drinking days HDD per week
Secondary Objectives
To compare the efficacy of psilocybin-assisted therapy versus control in improving the characteristics of AUD and addressing common comorbidities associated with AUD including depression and anxiety
Study Design
The trial will employ a double-blind randomised controlled design A sample of 90 individuals with AUD will undergo 14 weeks of treatment which includes 12 therapy sessions and 2 dosing sessions with either psilocybin 25 mg or control niacin 250mg Participants will be assessed for changes in alcohol consumption patterns and improvements in symptoms of depression and anxiety
Primary Objective
To conduct a double-blind randomised controlled trial with 90 participants diagnosed with Alcohol Use Disorder AUD The primary aim is to compare the efficacy of psilocybin-assisted therapy two sessions of psilocybin 25 mg per dosing session versus control niacin 250mg and therapy in reducing alcohol consumption specifically measuring the number of heavy drinking days HDD per week
Secondary Objectives
To compare the efficacy of psilocybin-assisted therapy versus control in improving the characteristics of AUD and addressing common comorbidities associated with AUD including depression and anxiety
Study Design
The trial will employ a double-blind randomised controlled design A sample of 90 individuals with AUD will undergo 14 weeks of treatment which includes 12 therapy sessions and 2 dosing sessions with either psilocybin 25 mg or control niacin 250mg Participants will be assessed for changes in alcohol consumption patterns and improvements in symptoms of depression and anxiety
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?:
True
Is an FDA AA801 Violation?:
None