Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160232
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-11-29
Brief Title:
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
Sponsor:
Brugmann University Hospital
Organization:
Brugmann University Hospital
Study Overview
Official Title:
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder Feasibility Clinical Efficacy NeuroCognitive Mechanisms
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder Protocol for a Double-Blind Randomized Placebo-Controlled 7-month Parallel-Group Phase II Superiority Trial
Detailed Description:
A substantial proportion of patients with alcohol use disorder does not respond to available treatments which calls for the development of new alternatives In parallel psilocybin-assisted therapy for alcohol use disorder has recently yielded promising preliminary results Building on extant findings the proposed study aims to determine the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy as a complementary intervention during inpatient rehabilitation for severe alcohol use disorder and to characterize associated changes in the two key neurocognitive systems identified by dual-process models of addiction
In this double-blind randomized placebo-controlled 7-month parallel-group phase II superiority trial 62 participants aged 21-64 years will be enrolled to undergo psilocybin-assisted therapy within the context of a 4-week inpatient rehabilitation for severe alcohol use disorder The experimental group will receive a high dose of psilocybin 30 mg whereas the control group will receive an active placebo dose of psilocybin both within the context of a brief standardized psychotherapeutic intervention The primary clinical outcome is the between-group difference in terms of the change in percentage of heavy drinking days from baseline to four weeks post-hospital discharge whilst safety and feasibility metrics will also be reported as primary outcomes Key secondary assessments include between-group differences in terms of changes in 1 drinking behavior parameters up to six months post-hospital discharge 2 phosphatidyl-ethanol blood concentration an objective biomarker of alcohol consumption 3 symptoms of depression anxiety trauma and global functioning 4 neuroplasticity and key neurocognitive mechanisms associated with addiction 5 psychological processes and alcohol-related parameters
In this double-blind randomized placebo-controlled 7-month parallel-group phase II superiority trial 62 participants aged 21-64 years will be enrolled to undergo psilocybin-assisted therapy within the context of a 4-week inpatient rehabilitation for severe alcohol use disorder The experimental group will receive a high dose of psilocybin 30 mg whereas the control group will receive an active placebo dose of psilocybin both within the context of a brief standardized psychotherapeutic intervention The primary clinical outcome is the between-group difference in terms of the change in percentage of heavy drinking days from baseline to four weeks post-hospital discharge whilst safety and feasibility metrics will also be reported as primary outcomes Key secondary assessments include between-group differences in terms of changes in 1 drinking behavior parameters up to six months post-hospital discharge 2 phosphatidyl-ethanol blood concentration an objective biomarker of alcohol consumption 3 symptoms of depression anxiety trauma and global functioning 4 neuroplasticity and key neurocognitive mechanisms associated with addiction 5 psychological processes and alcohol-related parameters
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002369-14 | EUDRACT_NUMBER | None | None |