Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study
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|ClinicalTrials.gov Identifier: NCT04030169|
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Drug: MDMA||Phase 2|
PTSD is a serious debilitating disorder that negatively impacts a person's 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 person's 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.
3,4-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 1.5 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Examining safety and effects of two sessions of MDMA-assisted psychotherapy, with Clinician-Administered PTSD Scale for DSM 5 (CAPS-5) severity after treatment compared with baseline|
|Masking:||None (Open Label)|
|Masking Description:||This study will be open label|
|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|
|Actual Study Start Date :||June 24, 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Experimental: MDMA-assisted psychotherapy
Two sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
Other Name: 3,4-methylenedioxymethamphetamine
- Change in CAPS-5 Total Severity Score [ Time Frame: 13 weeks post-enrollment ]The primary objective of this study is to evaluate the effectiveness of MDMA-assisted psychotherapy for treatment of PTSD, as measured by the estimand of change in CAPS-5 Total Severity Score
- Change in Sheehan Disability Scale (SDS) item scores [ Time Frame: 13 weeks post-enrollment ]The secondary objective is to evaluate the effectiveness of MDMA-assisted psychotherapy for PTSD in clinician-rated functional impairment, as measured by the mean change in Sheehan Disability Scale (SDS) item scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030169
|Contact: Fabiana da Silva Alvesemail@example.com|
|NUDZ - National Institute of Mental Health||Recruiting|
|Klecany, Středočeský Kraj, Czechia, 250 67|
|Contact: Michaela Victorinova +420283088258 firstname.lastname@example.org|
|Maastricht University, Dept of Neuropsychology and Psychopharmacology||Not yet recruiting|
|Maastricht, Limburg, Netherlands, 6229 ER|
|Contact: Kim Kuypers +31433881902 email@example.com|
|Stichting Centrum '45/Arq||Recruiting|
|Oegstgeest, Noord Holand, Netherlands, 2342 AX|
|Contact: Viyan Bedawi +31715191500 V.Bedawi@centrum45.nl|
|Sykehuset Østfold Hf, DPS Norder||Not yet recruiting|
|Moss, Norway, 1535|
|Contact: Study Team General +47 69 86 97 61 firstname.lastname@example.org|
|Fundação de Anna de Sommer Champalimaud||Not yet recruiting|
|Lisbon, Portugal, 1400-038|
|University Hospital of Wales - Research Facility||Not yet recruiting|
|Cardiff, United Kingdom, CF14 4XW|
|Contact: Mathew Hoskins email@example.com|
|Study Director:||Michael Mithoefer, MD||MAPS Public Benefit Corp.|