Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04264026
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-19
First Post:
2020-02-07
Brief Title:
MDMA-Assisted Psychotherapy in Veterans With Combat-Related Refractory PTSD
Sponsor:
VA Loma Linda Health Care System
Organization:
VA Loma Linda Health Care System
Study Overview
Official Title:
Open-label Phase 2 Study of MDMA-Assisted Psychotherapy in Veterans With Combat-Related Refractory PTSD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
VALLMDMA_001
Brief Summary:
This will be a single-site open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks along with preparatory and integration psychotherapy sessions in-between each active-dose session The overall objective of this study is to evaluate the risks benefits and feasibility of MDMA used in conjunction with manualized psychotherapy on reduction of symptoms or remission of PTSD as evaluated by standard clinical measures in a VA Healthcare System
The primary outcome measure for the study is the Clinician-Administered PTSD Scale CAPS-5 a semi-structured interview used in the majority of clinical trials for PTSD which will be assessed at baseline primary endpoint and at the long-term 12-month follow-up visit Secondary safety and efficacy measures will also be collected
The planned duration of this study is 1-3 years with each active treatment period lasting approximately 12 weeks along with a long-term follow-up 12 months after the last active-drug session
The primary outcome measure for the study is the Clinician-Administered PTSD Scale CAPS-5 a semi-structured interview used in the majority of clinical trials for PTSD which will be assessed at baseline primary endpoint and at the long-term 12-month follow-up visit Secondary safety and efficacy measures will also be collected
The planned duration of this study is 1-3 years with each active treatment period lasting approximately 12 weeks along with a long-term follow-up 12 months after the last active-drug session
Detailed Description:
This will be a single-site open-label study investigating the use of MDMA-assisted psychotherapy for treatment-resistant combat-related PTSD This study will consent up to 50 current-era combat veterans for study and the first 10 participants who meet criteria will be eligible to receive study medication Any patient who drops out before the third Experimental Session will be replaced Dropout rates will be recorded In this protocol enrollment is defined as the time the participant signs informed consent Time from initial screeningenrollment to collection of the primary endpoint will last approximately 12-18 weeks To assess durability of treatment participants will be assessed approximately 12 months after the last MDMA session for the long-term follow-up The study will consist of a prescreeningscreeningenrollment period three pre-experimental preparatory dose psychotherapy sessions spaced approximately one week apart three experimental dose therapy sessions nine integrative follow-up sessions one assessment of primary endpoint and a long-term 12-month follow-up assessment Psychiatric medication tapering will occur after eligibility confirmation after completion of baseline CAPS-5 prior to Experiential Sessions to allow for appropriate medication washout
The primary objective of this study is to evaluate the safety and effectiveness of MDMA in Veterans with combat-related refractory PTSD when used in conjunction with manualized psychotherapy on reduction of symptoms or remission of PTSD as evaluated by standard clinical measures
Effectiveness will be measured by evaluating the change in CAPS-5 scores from baseline to the primary endpoint Primary endpoint will be collected 2 months after the third Experimental Session with MDMA To access long-term effectiveness CAPS-5 will also be collected at the long-term follow-up
Secondary Objectives
1 Assess changes in self-reported PTSD symptoms as measured with the PTSD-symptom checklist at screening and baseline during most face-to-face visits at the primary endpoint and during the long-term follow-up
a Life Event Checklist LEC for PCL-5 will be administered at baseline screening primary endpoint and long-term follow-up
2 Assess depression symptoms with the Beck Depression Inventory-II BDI-II at baseline screening primary endpoint and long-term 12-month follow-up
3 Assess changes in alcohol consumption
1 The AUDIT-C Alcohol Use Disorders Identification Test will be used to measure baseline alcohol use over the past year prior to study entry at screening and at long-term follow up
2 Alcohol use starting after study screening will be monitored based on participants self-report Participants will be directed to keep a Drinking Diary throughout the study measuring the number of standard alcoholic beverages consumed per day Drinking Diary for each participant will be collected weekly until their last psychotherapy visit Participants will continue to record weekly alcohol use on their own until collection at the primary endpoint
4 Assess changes in drug consumption
a Drug Use Disorders Identification Test DUDIT will be assessed at baseline screening and at long-term follow-up
5 Assess changes in self-reported sleep quality via the Pittsburgh Sleep Quality Index PSQI from baseline screening to primary endpoint and long-term 12-month follow-up
6 Assess changes in posttraumatic growth via Post Traumatic Growth Inventory PTGI scores from baseline at screening to primary endpoint and long-term 12-month follow-up
7 Healthcare utilization will also be assessed by retrospective chart review
Twelve months after the final Experimental Session the long-term effects of MDMA-assisted psychotherapy on symptoms of PTSD will be assessed via CAPS-5 and PCL-5 with LEC alcohol use via AUDIT drug use behaviors via DUDIT depression via BDI-II self-reported sleep quality via PSQI post-traumatic growth via PTGI suicidality via C-SSRS and response to research participation via RRPQ Reactions to Research Participation Questionnaire
Participants will also be assessed for suicidality at every face-to-face visit
The primary objective of this study is to evaluate the safety and effectiveness of MDMA in Veterans with combat-related refractory PTSD when used in conjunction with manualized psychotherapy on reduction of symptoms or remission of PTSD as evaluated by standard clinical measures
Effectiveness will be measured by evaluating the change in CAPS-5 scores from baseline to the primary endpoint Primary endpoint will be collected 2 months after the third Experimental Session with MDMA To access long-term effectiveness CAPS-5 will also be collected at the long-term follow-up
Secondary Objectives
1 Assess changes in self-reported PTSD symptoms as measured with the PTSD-symptom checklist at screening and baseline during most face-to-face visits at the primary endpoint and during the long-term follow-up
a Life Event Checklist LEC for PCL-5 will be administered at baseline screening primary endpoint and long-term follow-up
2 Assess depression symptoms with the Beck Depression Inventory-II BDI-II at baseline screening primary endpoint and long-term 12-month follow-up
3 Assess changes in alcohol consumption
1 The AUDIT-C Alcohol Use Disorders Identification Test will be used to measure baseline alcohol use over the past year prior to study entry at screening and at long-term follow up
2 Alcohol use starting after study screening will be monitored based on participants self-report Participants will be directed to keep a Drinking Diary throughout the study measuring the number of standard alcoholic beverages consumed per day Drinking Diary for each participant will be collected weekly until their last psychotherapy visit Participants will continue to record weekly alcohol use on their own until collection at the primary endpoint
4 Assess changes in drug consumption
a Drug Use Disorders Identification Test DUDIT will be assessed at baseline screening and at long-term follow-up
5 Assess changes in self-reported sleep quality via the Pittsburgh Sleep Quality Index PSQI from baseline screening to primary endpoint and long-term 12-month follow-up
6 Assess changes in posttraumatic growth via Post Traumatic Growth Inventory PTGI scores from baseline at screening to primary endpoint and long-term 12-month follow-up
7 Healthcare utilization will also be assessed by retrospective chart review
Twelve months after the final Experimental Session the long-term effects of MDMA-assisted psychotherapy on symptoms of PTSD will be assessed via CAPS-5 and PCL-5 with LEC alcohol use via AUDIT drug use behaviors via DUDIT depression via BDI-II self-reported sleep quality via PSQI post-traumatic growth via PTGI suicidality via C-SSRS and response to research participation via RRPQ Reactions to Research Participation Questionnaire
Participants will also be assessed for suicidality at every face-to-face 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