Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784143
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2021-03-02
Brief Title:
Study Comparing Two Versus Three Active MDMA-assisted Sessions in US Military Veterans With Chronic PTSD
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
A Phase 2 Open-Label Randomized Comparative Effectiveness Study for MDMA-Assisted Psychotherapy in US Veterans With Chronic PTSD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
MPVA6
Brief Summary:
This open-label randomized study will assess the comparative effectiveness of two versus three active MDMA-assisted sessions in US military veterans with at least moderate chronic PTSD treated in an outpatient VA treatment clinic
Detailed Description:
This open-label randomized study will assess the comparative effectiveness of two versus three active MDMA-assisted therapy sessions in US military veterans with at least moderate chronic PTSD treated in an outpatient VA treatment clinic The study will be conducted in up to 60 participants Prior to the randomized portion of the study each therapist pair team will treat one participant under the 3-session model and one participant under the 2-session model In total 8 participants will be treated under this proof of principle therapist training lead-in A 120 mg dose of MDMA followed by a supplemental dose 60 mg unless contraindicated is administered during the treatment period with manualized psychotherapy in 2 or 3 open-label monthly Experimental Sessions This 8-12-week Treatment Period includes three Preparatory Sessions prior to the first MDMA-assisted session During the treatment period each Experimental Session is followed by three Integrative Sessions of non-drug therapy The Primary Outcome measure the change in CAPS-5 from Baseline is assessed by a centralized blinded Independent Rater IR pool at post-treatment for each group
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