Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418178
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-06
Brief Title:
Dose Optimization of MDMA-Assisted Therapy for PTSD
Sponsor:
Bronx VA Medical Center
Organization:
Bronx VA Medical Center
Study Overview
Official Title:
A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in US Veterans
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
DosOp
Brief Summary:
This open label within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles ie one MDMA session and three integration sessions in a sample of US veterans with PTSD Participants will complete from one to five cycles of MDMA-AT
Detailed Description:
This open label within-subjects dose optimization study will determine the optimal number of treatment cycles of MDMA-AT one cycle consists of one Experimental Session followed by three Integrative Sessions for significant improvement in a sample of US veterans with PTSD All participants will receive three non-drug preparatory sessions and at least one cycle of MDMA-assisted therapy with a team of two therapists Each cycle will consist of one approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions After each cycle participants will determine in consultation with their therapy team whether to continue with an additional cycle or to discontinue treatment The decision will reflect the participants perception of the potential for continued improvement eg as based on current symptom burden treatment response to date weighed against the burden of an additional cycle eg time required any adverse events or emotional burden Participants may complete up to a maximum of five cycles The dose optimizing design allows for the identification of the optimal number of MDMA-AT cycles to achieve the best response and to assess tolerability of multiple cycles of MDMA-AT Participants will also provide blood samples to be banked for future analysis of biological markers associated with treatment response
For each participant the study will consist of
Screening Period initial screen informed consent eligibility assessment
Enrollment Period with Enrollment Confirmation Enrollment and medication tapering period if needed followed by psychological assessment and Enrollment Confirmation collection of biomarker blood samples
Treatment Period 3 Preparatory sessions one to five Experimental Sessions each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists
Post-treatment Period and Study Termination Psychological Evaluation biomarker blood samples study termination visit
For each participant the study will consist of
Screening Period initial screen informed consent eligibility assessment
Enrollment Period with Enrollment Confirmation Enrollment and medication tapering period if needed followed by psychological assessment and Enrollment Confirmation collection of biomarker blood samples
Treatment Period 3 Preparatory sessions one to five Experimental Sessions each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists
Post-treatment Period and Study Termination Psychological Evaluation biomarker blood samples study termination visit
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