Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04030169
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2019-07-19
Brief Title:
Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study
Sponsor:
MAPS Europe BV
Organization:
MAPS Europe BV
Study Overview
Official Title:
An Open-Label Phase 2 Multicenter Feasibility Study of Manualized MDMA-Assisted Psychotherapy With an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects With Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
This open-label lead-in Phase 2 study is intended to gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD This will be the first study of MDMA-assisted psychotherapy in Europe using the CAPS-5 as a primary outcome measure to confirm assumptions made for statistical power calculations using the Clinician-Administered PTSD Scale for DSM-4 CAPS-4 which support planned Phase 3 clinical trials This study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD and provide clinical supervision to planned Phase 3 therapy teams This study will also be the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated trials in a multi-site format to further confirm the Phase 3 study design This study will compare the effects of two open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose followed 15 to 2 hours later by a supplemental half-dose 40 mg or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg
Detailed Description:
PTSD is a serious debilitating disorder that negatively impacts a persons daily life PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war disaster sexual abuse violence terrorism and accidents PTSD negatively impacts a persons daily life resulting in relationship difficulties difficulty in finding and maintaining a job reduced cognitive and psychosocial functioning substance abuse high-cost healthcare use and increased depression and suicide risk Available PTSD treatments including medications and therapy effectively treat only a fraction of people who try them for adequate dose and duration People with PTSD can be treated with psychotherapies and pharmacotherapies In the past decade there has been a growing amount of research into medications and other methods that may augment the effectiveness of psychotherapy for PTSD
34-methylenedioxymethamphetamine is a drug that releases serotonin norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin arginine vasopressin and cortisol The combined neurobiological effects of MDMA increase compassion reduce defenses and fear of emotional injury and enhance communication and introspection MDMA produces anxiolytic and prosocial effects which counteract avoidance and hyperarousal in the context of therapy A combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD
This multicenter open-label lead-in study assesses the safety and effectiveness of MDMA- assisted psychotherapy in participants diagnosed with at least severe PTSD All safety data will be included in the global safety database for MDMA maintained by MAPS Some sites will participate in the imaging sub-study A flexible dose of MDMA followed by a supplemental half-dose unless contraindicated is administered during the Treatment Period with manualized psychotherapy in two open-label Experimental Sessions spaced approximately a month apart This 8-week Treatment Period is preceded by three Preparatory Sessions During the Treatment Period each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy Exploratory measures will address specific symptoms or behavior that is sometimes related to PTSD Drug safety will be assessed by measuring blood pressure heart rate and body temperature during experimental sessions collecting adverse events and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale CSSRS This study will compare the effects of two open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose followed 15 to 2 hours later by a supplemental half-dose 40 mg or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg
This study will be the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated trials in a multi-site format to further confirm the Phase 3 study design
34-methylenedioxymethamphetamine is a drug that releases serotonin norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin arginine vasopressin and cortisol The combined neurobiological effects of MDMA increase compassion reduce defenses and fear of emotional injury and enhance communication and introspection MDMA produces anxiolytic and prosocial effects which counteract avoidance and hyperarousal in the context of therapy A combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD
This multicenter open-label lead-in study assesses the safety and effectiveness of MDMA- assisted psychotherapy in participants diagnosed with at least severe PTSD All safety data will be included in the global safety database for MDMA maintained by MAPS Some sites will participate in the imaging sub-study A flexible dose of MDMA followed by a supplemental half-dose unless contraindicated is administered during the Treatment Period with manualized psychotherapy in two open-label Experimental Sessions spaced approximately a month apart This 8-week Treatment Period is preceded by three Preparatory Sessions During the Treatment Period each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy Exploratory measures will address specific symptoms or behavior that is sometimes related to PTSD Drug safety will be assessed by measuring blood pressure heart rate and body temperature during experimental sessions collecting adverse events and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale CSSRS This study will compare the effects of two open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose followed 15 to 2 hours later by a supplemental half-dose 40 mg or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg
This study will be the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated trials in a multi-site format to further confirm the Phase 3 study design
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