Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961527
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-07-17
Brief Title:
Group MDMA-therapy for Veterans With PTSD
Sponsor:
Portland VA Research Foundation Inc
Organization:
Portland VA Research Foundation Inc
Study Overview
Official Title:
An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans
Status:
ACTIVE_NOT_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:
Group-MVP
Brief Summary:
This Phase 2a open-label non-randomized 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans The study will be conducted in up to N18 participants recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts
Detailed Description:
To assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD the sponsor-investigator is conducting a phase 2 open-label non-randomized 3-cohort study This novel treatment package consists of two once-monthly open-label MDMA Sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions The Primary Clinical Outcome measure the Clinician Administered PTSD Scale CAPS-5 evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater IR pool The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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