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 |
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Recruitment Status :
Recruiting
First Posted : July 23, 2019
Last Update Posted : August 29, 2022
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| 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 |
| Allocation: | N/A |
| 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 |
| Primary Purpose: | Treatment |
| 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 : | November 2022 |
| Estimated Study Completion Date : | November 2022 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: MDMA
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Are able to swallow pills
- Agree to have study visits video-recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
- Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
- Must agree to inform the investigators within 48 hours of any medical treatments and procedures
- People able to become pregnant (PABP) (i.e., assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
Exclusion Criteria:
- Are not able to give adequate informed consent
- Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
- Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist
- Require ongoing concomitant therapy with a psychiatric medication (exceptions apply)
- Weigh less than 48 kilograms (kg)
- Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of birth control.
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: Recruitment Officer | askmapseu@mapseurope.eu |
| Czechia | |
| NUDZ - National Institute of Mental Health | Active, not recruiting |
| Klecany, Středočeský Kraj, Czechia, 250 67 | |
| Germany | |
| Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf | Not yet recruiting |
| Martinsried, Hamburg, Germany, 20246 | |
| Contact: Study Coordinator +49 (0)40 7410 57902 MDMA.Trial.UKE@zis-hamburg.de | |
| Charité - Universitätsmedizin, Berlin Campus Benjamin Franklin | Recruiting |
| Berlin, Germany, 12203 | |
| Contact mdma@charite.de | |
| Netherlands | |
| Maastricht University, Dept of Neuropsychology and Psychopharmacology | Recruiting |
| Maastricht, Limburg, Netherlands, 6229 ER | |
| Contact: Kim Kuypers +31433881902 Fpn-maps@maastrichtuniversity.nl | |
| Stichting Centrum '45/Arq | Recruiting |
| Oegstgeest, Noord Holand, Netherlands, 2342 AX | |
| Contact: Viyan Bedawi +31715191500 OnderzoekMDMA@arq.org | |
| Norway | |
| Sykehuset Østfold Hf, DPS Norder | Active, not recruiting |
| Moss, Norway, 1535 | |
| Portugal | |
| Fundação de Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud | Not yet recruiting |
| Lisbon, Portugal, 1400-038 | |
| Contact: Manuela Seixas +351 965 289 072 manuela.seixas@fundacaochampalimaud.pt | |
| United Kingdom | |
| University Hospital of Wales - Research Facility | Enrolling by invitation |
| Cardiff, United Kingdom, CF14 4XW | |
| The Institute of Psychiatry, Psychology and Neuroscience | Enrolling by invitation |
| London, United Kingdom, SE5 8AF | |
| Principal Investigator: | Prof. Dr. Eric Vermetten, MD | Leiden University Medical Center |
| Responsible Party: | MAPS Europe B.V. |
| ClinicalTrials.gov Identifier: | NCT04030169 |
| Other Study ID Numbers: |
MP18 |
| First Posted: | July 23, 2019 Key Record Dates |
| Last Update Posted: | August 29, 2022 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We will share outcome data appearing in any published reports upn request. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Data and study-related documents will be available when all participants have completed the study. |
| Access Criteria: | Interested persons should correspond with the central contact for the multi-site study. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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MDMA methylenedioxymethamphetamine psychotherapy PTSD Posttraumatic Stress Disorder |
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Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Mental Disorders N-Methyl-3,4-methylenedioxyamphetamine Hallucinogens Physiological Effects of Drugs Psychotropic Drugs |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Adrenergic Agents |