Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117306
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-27
Brief Title:
MDMA-assisted Massed Prolonged Exposure for PTSD
Sponsor:
Healing Breakthrough
Organization:
San Diego Veterans Healthcare System
Study Overview
Official Title:
MDMA-assisted Massed Prolonged Exposure for PTSD
Status:
RECRUITING
Status Verified Date:
2024-09
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:
MDMA-PE
Brief Summary:
The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol aE-MDMA-PE and assess the effect on clinician-rated PTSD symptoms in veterans who receive full-dose MDMA and veterans who receive low-dose MDMA
Detailed Description:
The study is a randomized pilot study that will evaluate the preliminary efficacy safety tolerability and acceptability of the intervention in a sample of US veterans seeking PTSD treatment at the VASDHS Ten veterans will be randomized in a 11 ratio to receive MDMA in a standard dose 120 mg MDMA HCl 102 mg MDMA rounded or low dose 40 mg MDMA HCl 34 mg MDMA based on the 2-week Emory MDMA-PE Protocol developed by Maples-Keller and Rothbaum The current protocol will entail massed-PE and the MDMA administration spanning up to 3-weeks PE will involve twelve 90-minute sessions with the initial two sessions both occurring during the first treatment visit the third and fourth sessions occurring during the MDMA session and the remaining sessions occurring daily or every other day M-F for two to three weeks
Following the baseline assessment during Visit 1 participants will begin PE during Visit 2 which will include psychoeducation rationale for exposure-based treatment discussion of the SUDS scale and creating the in vivo exposure hierarchy Visit 3 will be the Preparatory Session in which we will provide psychoeducation regarding MDMAs subjective effects and strategies for MDMA-related support Visit 4 will include the MDMA administration which will include the third and fourth PE sessions including the first and second imaginal exposures Participants will report SUDS at the start and end of imaginal exposure At the beginning of Visit 5 following a modified version of the MAPS Integration session criteria the therapist and patient will focus on developing a deeper understanding of insights from the MDMA session and any thoughts or feelings regarding the patients experience of PTSD and its impact on their life After the Integration session there will be a 30-minute break before the PE session Visits 5-12 will include imaginal exposures and processing of the in-session experience Imaginal exposures will be recorded and participants will listen to this recording as homework Each visit an in vivo exposure will be assigned for homework all sessions will begin with a check-in that includes reviewing this exposure experience The post-treatment questionnaire assessment will occur on Visit 13 Participants will complete post-treatment follow-up CAPS-5 clinical interviews remotely within 1 week 2 months and 4 months after treatment Following the 2-month follow-up assessment and unblinding veterans in the low dose condition will be offered an optional additional standard-dose MDMA session and up to three optional additional integration sessions
Following the baseline assessment during Visit 1 participants will begin PE during Visit 2 which will include psychoeducation rationale for exposure-based treatment discussion of the SUDS scale and creating the in vivo exposure hierarchy Visit 3 will be the Preparatory Session in which we will provide psychoeducation regarding MDMAs subjective effects and strategies for MDMA-related support Visit 4 will include the MDMA administration which will include the third and fourth PE sessions including the first and second imaginal exposures Participants will report SUDS at the start and end of imaginal exposure At the beginning of Visit 5 following a modified version of the MAPS Integration session criteria the therapist and patient will focus on developing a deeper understanding of insights from the MDMA session and any thoughts or feelings regarding the patients experience of PTSD and its impact on their life After the Integration session there will be a 30-minute break before the PE session Visits 5-12 will include imaginal exposures and processing of the in-session experience Imaginal exposures will be recorded and participants will listen to this recording as homework Each visit an in vivo exposure will be assigned for homework all sessions will begin with a check-in that includes reviewing this exposure experience The post-treatment questionnaire assessment will occur on Visit 13 Participants will complete post-treatment follow-up CAPS-5 clinical interviews remotely within 1 week 2 months and 4 months after treatment Following the 2-month follow-up assessment and unblinding veterans in the low dose condition will be offered an optional additional standard-dose MDMA session and up to three optional additional integration sessions
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