Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 9:26 AM
Study NCT ID:
NCT04714359
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
Sponsor:
Organization:
Raw JSON
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Therapeutics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to end of follow up (approximately 18 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-Treatment MDMA-Assisted Therapy', 'description': 'Adverse events that occur during the Preparatory Period prior to the first dose in the first MDMA-assisted therapy session.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 51, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'On Day 0, 1, or 2 MDMA-Assisted Therapy', 'description': 'Adverse events that occur on the day of or within two days following each MDMA-assisted therapy session.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 84, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment-Emergent Adverse Events MDMA-Assisted Therapy', 'description': 'Adverse events that occur during the Treatment Period from the first Experimental Session to the last Integrative Session.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 84, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Follow-Up MDMA-Assisted Therapy', 'description': 'Adverse Events that occurred after the last Integrative Session through follow-up.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 15, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Therapeutic response unexpected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling of body temperature change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling of relaxation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emotional disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85}, {'groupId': 'EG001', 'numAtRisk': 85}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85}, {'groupId': 'EG001', 'numAtRisk': 85}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85}, {'groupId': 'EG001', 'numAtRisk': 85}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85}, {'groupId': 'EG001', 'numAtRisk': 85}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85}, {'groupId': 'EG001', 'numAtRisk': 85}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85}, {'groupId': 'EG001', 'numAtRisk': 85}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85}, {'groupId': 'EG001', 'numAtRisk': 85}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Visit 16 in PCL-5 Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MDMA-assisted Therapy', 'description': 'Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later\n\nMidomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.92', 'groupId': 'OG000', 'lowerLimit': '-18.05', 'upperLimit': '-11.79'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)', 'description': 'The Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. Participants indicate how much distress they have experienced in the last 2 weeks due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" on a five-point Likert-type scale (0=Not at all to 4=Extremely). The total severity score can range from 0 to 80 and lower scores indicate less PTSD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome analysis (change from baseline) is based on the n=81 participants with PCL-5 data available at the primary outcome visit (Visit 16).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Visit 16 in Sheehan Disability Scale (SDS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MDMA-assisted Therapy', 'description': 'Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later\n\nMidomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.10', 'groupId': 'OG000', 'lowerLimit': '-5.95', 'upperLimit': '-2.25'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)', 'description': 'The SDS is a self-report assessment of functional impairment. The reporting period for the SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MDMA-assisted Therapy', 'description': 'Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later\n\nMidomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Participants who were randomized to the placebo arm in the two parent Phase 3 trials and who meet all other entry criteria will be eligible and invited to participate in this open-label safety extension study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MDMA-assisted Therapy', 'description': 'Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later\n\nMidomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': '9.93', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '2.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Trauma History', 'classes': [{'title': 'Veteran', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Served in combat area', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Multiple traumatic events', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 1279689, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-09T16:06', 'hasProtocol': True}, {'date': '2021-04-13', 'size': 5825374, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-18T16:54', 'hasProtocol': False}, {'date': '2023-05-04', 'size': 487234, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-11T19:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2021-01-14', 'resultsFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-21', 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Visit 16 in PCL-5 Total Score', 'timeFrame': 'Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)', 'description': 'The Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. Participants indicate how much distress they have experienced in the last 2 weeks due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" on a five-point Likert-type scale (0=Not at all to 4=Extremely). The total severity score can range from 0 to 80 and lower scores indicate less PTSD symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Visit 16 in Sheehan Disability Scale (SDS) Total Score', 'timeFrame': 'Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)', 'description': 'The SDS is a self-report assessment of functional impairment. The reporting period for the SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study.\n\nThe main question it aims to answer is:\n\nDo PTSD symptoms decrease in people who receive a flexible dose of MDMA (120 or 180 mg MDMA HCl) with therapy in three sessions?\n\nParticipants will undergo three preparatory therapy sessions without any study drug, then three MDMA-assisted therapy sessions with a flexible dose of 80 or 120 mg, followed by three integrative therapy sessions without study drug after each MDMA-assisted therapy session.', 'detailedDescription': 'This multi-site, open-label safety extension study assesses the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy in participants diagnosed with PTSD. The study will be conducted in N ≈ 100 participants. Participants who were randomized to the placebo arm in either of the two parent Phase 3 trials of MDMA-assisted psychotherapy and who meet all other entry criteria will be eligible and invited to participate in this study. In addition, participants in the parent Phase 3 trials who were unable to complete the study due to the COVID-19 pandemic or other unforeseen circumstances may participate in this study.\n\nThe treatment consists of an initial dose of midomafetamine HCl (80 or 120 mg), followed by a supplemental dose (40 or 60 mg) unless contraindicated, administered with manualized psychotherapy in three open-label Experimental Sessions each spaced approximately one month apart. During Experimental Session 1, participants will receive an initial dose of 80 mg of midomafetamine HCl, followed by a supplemental dose of 40 mg. During Experimental Sessions 2 and 3, participants will receive an initial dose of 80 or 120 mg of midomafetamine HCl, followed by a supplemental dose of 40 or 60 mg.\n\nThis 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. Experimental Sessions are followed by an overnight stay, with the exception of a subset of participants who will be invited to participate in a sub-study to assess the feasibility of Experimental Sessions without overnight stay. The primary study endpoint is the change from baseline in PCL-5 (PTSD Checklist for DSM-5) scores from Visit 3 to Visit 16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Were previously enrolled in a parent study and (meet one of the following):\n\n 1. At time of unblinding, their treatment assignment was to the placebo arm; or,\n 2. Did not begin Experimental Sessions due to the COVID-19 global pandemic or other unforeseen circumstances;\n 3. Completed fewer than three Experimental Sessions prior to Study Termination due to the COVID-19 global pandemic or other unforeseen circumstances.\n* Are considered in good standing with the study site at which they enrolled in a parent study; if, in the opinion of the investigator, therapy team, and Medical Monitor, the participant was compliant with protocol requirements, even if they were unable to complete all study visits.\n* Are at least 18 years old\n* Are fluent in speaking and reading the predominantly used or recognized language of the study site\n* Are able to swallow pills\n* Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions\n* Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.\n* Must agree to inform the investigators within 48 hours of any medical conditions and procedures\n* If of childbearing potential, must have a 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.\n* Must not participate in any other interventional clinical trials during the duration of the study\n* Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions.\n* Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.\n\nExclusion Criteria:\n\n* Are not able to give adequate informed consent Have uncontrolled hypertension\n* Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\>450 milliseconds \\[ms\\] in males and \\>460 ms in females corrected by Fridericia formula)\n* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n* Have evidence or history of significant medical disorders, such as myocardial infarction, cerebrovascular accident, or aneurysm\n* Have symptomatic liver disease\n* Have recent history of hyponatremia or hyperthermia\n* Weigh less than 48 kilograms (kg)\n* Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control\n* Have an active illicit or prescription drug substance use disorder within 12 months'}, 'identificationModule': {'nctId': 'NCT04714359', 'acronym': 'MAPPUSX', 'briefTitle': 'A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lykos Therapeutics'}, 'officialTitle': 'A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'MAPPUSX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDMA-assisted therapy', 'description': 'Three open-label sessions of MDMA-assisted therapy, each scheduled approximately 1 month apart, with initial dose of midomafetamine HCl of 80 or 120 mg and optional supplemental dose half that of initial dose (40 or 60 mg) 1.5 to 2 hours later', 'interventionNames': ['Drug: Midomafetamine HCl']}], 'interventions': [{'name': 'Midomafetamine HCl', 'type': 'DRUG', 'otherNames': ['3,4-methylenedioxymethamphetamine', 'MDMA HCl', 'midomafetamine', 'MDMA'], 'description': 'Initial doses per Experimental Session include 80 mg or 120 mg midomafetamine HCl, followed 1.5 to 2 hours later by a supplemental dose unless tolerability issues emerge. For an initial dose of 80 mg, a 40 mg supplemental dose will be used. For an initial dose of 120 mg, a 60 mg supplemental dose will be used. Total amounts of midomafetamine HCl to be administered per Experimental Session range from 80 mg to 180 mg.', 'armGroupLabels': ['MDMA-assisted therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90004', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'New School Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Insight and Integration Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94122', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80302', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aguazul-Blue Water Inc.', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Wholeness Center', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '70123', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ray Worthy Psychiatry', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02446', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Trauma Research Foundation', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11012', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Private Practice', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Zen Therapeutic Solutions, LLC', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '53705-2222', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'V5R 5H3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Numinus', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'H2W 1Y9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Numinus', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Beer Yaaqov', 'country': 'Israel', 'facility': 'Beer Yaakov Mental Health Center'}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Hashomer', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data and study-related documents will be available when the database has been locked and data has been unblinded.', 'ipdSharing': 'YES', 'description': 'We will share outcome data appearing in any published reports upon request.', 'accessCriteria': 'Interested persons should correspond with the central contact for the multisite study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lykos Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}