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Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. 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. This multicenter, open-label, lead-in study assesses the safety and effectiveness of MDMA- assisted psychotherapy in participants diagnosed with at least severe PTSD. 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. 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. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms x. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : March 5, See Contacts and Locations. Study Description. 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 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. Detailed Description:. Arms and Interventions. Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. 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 Women of childbearing potential i. Adequate birth control methods include intrauterine device IUD , injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner. Contacts and Locations. Information from the National Library of Medicine 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. Bedawi centrum Multidisciplinary Association for Psychedelic Studies. More Information. Access Criteria: Interested persons should correspond with the central contact for the multi-site study. Layout table for additional information Studies a U. MDMA methylenedioxymethamphetamine psychotherapy. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: MDMA. Phase 2. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Contact mdma charite. Maastricht University, Dept of Neuropsychology and Psychopharmacology. Contact: Inger-Tove Jentoft van de Vooren 95 86 84 94 inger. Contact: Mathew Hoskins hoskinsmd1 cardiff. The Institute of Psychiatry, Psychology and Neuroscience. July 23, Key Record Dates. We will share outcome data appearing in any published reports upn request. Data and study-related documents will be available when all participants have completed the study. Interested persons should correspond with the central contact for the multi-site study.

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