Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05709353
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-01-20
Brief Title:
MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
A Randomised Controlled Trial of MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder
Status:
RECRUITING
Status Verified Date:
2023-11
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:
MPATHY
Brief Summary:
To explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a double-blind randomised placebo-controlled trial
Detailed Description:
New strategies for the treatment of comorbid PTSD and alcohol dependence are urgently required Recent evidence has shown strong support for trauma-focused integrated treatments namely COPE however only 49 demonstrate clinically significant improvements MDMA may be a promising approach to improve response to COPE for this population Emerging evidence suggests that MDMA-assisted therapy may be of promise for PTSD and has demonstrated a good safety profile and potential efficacy in alcohol dependence
This project will evaluate the clinical efficacy and tolerability of MDMA-assisted COPE relative to a control-assisted COPE Active control used in this study is niacin The investigators hypothesise that MDMA treated participants will be have a reduction in PTSD symptom severity as well as heavy drinking
The trial will utilise a double blind randomised controlled design A sample of 120 individuals will receive 14 weeks of treatment including 12 COPE sessions and 2 dosing sessions with MDMA 80-160mg or control niacin 250mg
This project will evaluate the clinical efficacy and tolerability of MDMA-assisted COPE relative to a control-assisted COPE Active control used in this study is niacin The investigators hypothesise that MDMA treated participants will be have a reduction in PTSD symptom severity as well as heavy drinking
The trial will utilise a double blind randomised controlled design A sample of 120 individuals will receive 14 weeks of treatment including 12 COPE sessions and 2 dosing sessions with MDMA 80-160mg or control niacin 250mg
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