Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT07301632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018817', 'term': 'N-Methyl-3,4-methylenedioxyamphetamine'}, {'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Preparatory psychotherapy from week 1 to 5; a single dosing session with psychotherapy at week 6 and integrative psychotherapy at weeks 7 to 16.\n\nFollow up for primary clinical endpoint and final follow up at week 16.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome of this pilot trial is to determine feasibility of a large-scale, multi-center trial.', 'timeFrame': '16 weeks', 'description': 'Average Monthly recruitment of \\>1 participant per center means that the full trial should meet recruitment requirements within 12 months.'}, {'measure': 'Secondary feasibility outcome', 'timeFrame': '16 weeks', 'description': 'Data completion rate (of primary clinical outcome)≥ 80%'}, {'measure': 'Participant Retention', 'timeFrame': '16 weeks', 'description': "Retention of ≥80% of participants at the reported primary outcome point of 16 weeks after the experimental session should minimize attrition bias in the definitive trial's primary outcome data (e.g. withdrawal due to side-effects)"}, {'measure': 'Blinding', 'timeFrame': '16 weeks', 'description': 'Blinding Integrity (≤80% of participants in both arms correctly guess their treatment allocation (Note: 50% of participants would be expected to correctly guess treatment allocation due to chance alone)'}, {'measure': 'Adverse Events', 'timeFrame': '16 weeks', 'description': '≤3 serious drug-related adverse events'}, {'measure': 'Secondary Feasibility Outcome', 'timeFrame': '16 weeks', 'description': 'identification of patient, clinician and researcher-identified trial barriers using qualitative methods (e.g. interviews at the end of the study with participants who provides consent )'}], 'secondaryOutcomes': [{'measure': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) pain Intensity, Pain Interference and Physical Function Scale', 'timeFrame': 'Week 1, Week 7, Week 11 and Week 16', 'description': 'In the past 7 days patients to rate their pain on average- 0 scale-indicates No pain and 10 scale- indicates Worst imaginable pain'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Week 1, Week 7, Week 11 and Week 16', 'description': 'Over the last 2 weeks how often the patient has been bothered by daily activities on a scale of 0 to 3. 0 (Not at all) and 3 (Nearly every day)'}, {'measure': 'Generalized Anxiety Disorder 7-Item (GAD-7) Questionnaire', 'timeFrame': 'Week 1, Week 7, Week 11 and Week 16', 'description': 'Over the last 2 weeks, how often patients have been bothered by anxiety on a scale of 0 to 3. 0 equals Not at all and 3 equals Nearly every day'}, {'measure': 'The Post traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual for Mental Disorder-5 (PCL-5)', 'timeFrame': 'Week 1, Week 7, Week 11 and Week 16', 'description': 'Over the past month, how patients were bothered by internal and external feelings like stress, negativity etc. This is measured on a scale of 0 (Not at all) to 4 (Extremely)'}, {'measure': 'Health Questionnaire (EQ-5D-5L)', 'timeFrame': 'Week 1, Week 7, Week 11 and Week 16', 'description': 'Patients to describe how their health is affected in terms of mobility, self-care, Usual activities like (work, study, family), Pain/Discomfort, Anxiety/Depression on a scale of 0( Worst health you can imagine) to 100 (Best health you can imagine)'}, {'measure': 'The Patient Global Impression of Change Scale (PGIC)', 'timeFrame': 'Week 7, Week 11 and Week 16', 'description': 'This questionnaire measures how the patient impression changed before being enrolled in the study. Measured in a scale of 1 (Very much Improved) to 7 ( Very Much Worse)'}, {'measure': 'The Toronto Side Effect Scale (TSES)', 'timeFrame': 'Week 7, Week 11 and Week 16', 'description': "This questionnaire measures patient's symptoms in the last two weeks for Agitation, tremor, twitching etc in terms of frequency and Severity in a scale of 1 (Never) to 5 (Every day)"}, {'measure': 'STAR-P', 'timeFrame': 'Week 7, Week 11 and Week 16', 'description': "This questionnaire measures patient's perception and attitude regarding the clinician on a scale of 0 (Never) to 4 (Always)"}, {'measure': 'Subjective Drug Effects (VAS)', 'timeFrame': 'Week 6', 'description': 'On a scale of 0 (Not at all) to 10 (Extremely) patients to describe their experience during intervention session regarding the subjective drug effects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3, 4-methylenedioxymethamphetamine hydrochloride', 'Chronic Neuropathic Pain'], 'conditions': ['Chronic Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'This is a Health Canada regulated internal pilot study designed to assess the feasibility, tolerability, and preliminary efficacy of 3, 4-methylenedioxymethamphetamine hydrochloride capsules-AT for chronic neuropathic pain to inform a larger, fully powered multi-center study. This is an interventional, randomized, 2-arm parallel, triple blinded study.\n\nThe total study duration is 2 years.\n\nParticipants will receive preparatory psychotherapy session during week 2 and week 4 followed by a combined single dosing session with psychotherapy during week 6. Integrative psychotherapy will follow at weeks 6, 8, 12, and 16.\n\nFollow up for primary clinical endpoint at week 16; final follow up for secondary clinical endpoint at 16-weeks.\n\nParticipants will be asked to complete adjunctive home psychotherapy in the form of online modules. Data collected will be entered in electronic case report form (REDCap Academic).', 'detailedDescription': 'Primary objective:\n\nTo demonstrate the feasibility of conducting the full EASE Pain trial by achieving targets in recruitment, data completion rate, blinding integrity, minimal serious drug-related adverse events, and by identifying barriers and facilitators to the full trial.\n\nSecondary objectives (full trial):\n\nTo evaluate whether a 120 mg dose of oral 3,4-methylenedioxymethamphetamine with an optional 40mg supplementary dose leads to meaningful improvements in pain interference at 16-weeks in patients with moderate-to-severe chronic neuropathic pain compared to active-placebo, and assess changes in physical function, physical activity, emotional function, overall rating of improvement, and adverse events over 16 weeks.\n\nStudy type: Intervention trial Allocation: Randomized Intervention model: 2-Arm Parallel Group Primary purpose: Feasibility Phase: Phase II Blinding: Triple blinded (patient- outcome assessor- and psychotherapist-blinded)\n\nTotal study duration: 2 years Duration for each subject: 16 weeks. Preparatory psychotherapy from week 1 to 5; a single dosing session with psychotherapy at week 6 and integrative psychotherapy at weeks 7 to 16.\n\nFollow up for primary clinical endpoint and final follow up at week 16.\n\nDosage regimen:\n\nTreatment arm: 3,4-methylenedioxymethamphetamine 120mg (3 x 40mg capsule) PO single dose plus psychological support; optional 40mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose 160mg)\n\nPlacebo arm: Methylphenidate 30mg (3 x 10mg capsule) PO single dose plus psychological support; optional 10mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose of 40 mg)\n\nTreatment/ assessment visits:\n\nWeek -1: Screening Week 1: Baseline data collection, psychotherapy workbook 1 (preparation) Week 2: Psychotherapy preparatory session 1 Week 3: Psychotherapy workbook 2 (preparation) Week 4: Psychotherapy preparation session 2 Week 5: Psychotherapy workbook 3 (preparation) Week 6: (Day 0): Randomization to drug and experimental session with in-person psychotherapy (Day 1) Psychotherapy integration session 1 Week7: Psychotherapy workbook 4 (integration). Questionnaire and AE follow up Week 8: Psychotherapy integration session 2 Week 9 to 11 Psychotherapy workbook 5 (integration) Week 10: Questionnaire and AE follow up Week 12: Psychotherapy integration session 3 Week 13 to 15: Psychotherapy workbook 6 (integration) Week 16: Psychotherapy integration session 4. Primary clinical end point (Questionnaires and Adverse Event (AE) follow up)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Consenting adults 18 years and older.\n* Diagnosis of chronic neuropathic pain (greater than 3 months in duration) by a clinician with specialized training in chronic pain, confirmed with the standardized Leeds Assessment of Neuropathic Symptoms and Signs questionnaire.\n* Suffering from moderate-to-severe pain as defined by\n* Baseline Patient Reported Outcomes Measurement System - Pain Interference (PROMIS-PI) score of greater than or equal to 60\n* An average pain intensity of greater than or equal to 5 on a 0-10 numeric rating scale,43\n* Treatment-refractory pain as defined by a failure of ≥2 medications recommended in the Canadian consensus guidelines on the management of CNP to generate self-reported meaningful improvement in symptoms.\n* For participants of childbearing potential, use of a highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the participant.\n* Sufficient English skills to participate in psychotherapy.\n\nExclusion Criteria:\n\n* Past or current history of a psychotic disorder, mania, hypomania, bipolarity, current suicidal ideation, stimulant use disorder (i.e., cocaine, amphetamine, methamphetamine, MDMA, methylphenidate (Ritalin), etc , and any other substance use disorder within the past 12 months assessed by history and confirmed the Mini-International Neuropsychiatric Interview \\[MINI\\]. Other secondary psychiatric comorbidities (e.g., anxiety disorders, trauma related disorders, other personality disorders. etc.) will not be excluded\n* Participants with a history of suicide attempts are not excluded unless a significant risk of suicidal behavior is present at the time of screening as determined by the CRSS (Columbia suicide rating scale)\n* History of prior MDMA use (excluded to maintain blinding integrity)\n* Long QT syndrome, measured by an ECG with a QTc more than 450 ms for males, and 470 ms for females.\n* Presence of a relative or absolute contraindication to MDMA or Methylphenidate:\n* Pre-existing cardiovascular disorders evidenced in clinical records or disclosed on patient self-report, such as: uncontrolled hypertension (sustained blood pressure ≥160/100 mmHg), angina (ongoing angina at rest, recent hospitalization for acute coronary syndrome within the past 3 months, or a history of revascularization (e.g., stenting or bypass surgery) within the past 6 months), arterial occlusive disease; heart failure, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction (within the past 6 months), potentially life-threatening arrhythmias (new-onset within the last 3 months), arrhythmias causing hemodynamic instability (SBP \\< 90 mm Hg), or requiring urgent intervention (e.g., atrial fibrillation with rapid ventricular response or ventricular tachycardia), channelopathies, aneurysmal vascular disease (e.g., thoracic and/or abdominal aorta, intracranial, and peripheral arterial vessels), advanced arteriosclerosis\n* Cerebrovascular conditions: acute stroke or recent history of intracerebral hemorrhage (ischemic or hemorrhagic stroke occurring within the past 6 months)\n* Conditions at risk of elevation of blood pressure and increase heart rate, such as glaucoma, tension, agitation, thyrotoxicosis, pheochromocytoma\n* Motor tics and/or family history or diagnosis of Tourette's syndrome\n* Moderate to severe chronic kidney disease or kidney failure, such as requiring dialysis, significant treatment adjustments for kidney function, or regular nephrologist follow-up)\n* Moderate to severe liver disease, such as cirrhosis, a history of significant jaundice unrelated to temporary illness, or any liver condition requiring regular monitoring by a specialist).\n* Current treatment with selective serotonin reuptake inhibitors (SSRI's) and serotonin-norepinephrine reuptake inhibitors (SNRI's), tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans) and 5-HT3 receptor antagonist antiemetics (risk of Serotonin Syndrome)\n* Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (methylphenidate contains lactose)\n* Seizure disorders\n* Pregnancy, or breastfeeding\n* Known hypersensitivity to study drugs or any study drug excipients\n* Medications that interact with study drugs including:\n* Any lifetime history use of any stimulant medication (e.g., Adderall, Vyvanse, Ritalin)\n* Caffeine intake within 24 hours\n* Monoamine oxidase inhibitors (MAOI) within 14 days (e.g. phenelzine, moclobemide, isoniazid, linezolid, phenelzine, harmine) due to risk of hypertensive crisis\n* CYP2D6 substrates and modifiers (such as: buproprion, fluoxetine, paroxetine, duloxetine, mirabegron).\n* Adrenergic agents (e.g. clonidine) risk of sudden death\n* Vasopressor agents (ephedrine pseudoephedrine)\n* Coumarin anticoagulants (e.g., warfarin),\n* Anticonvulsants (e.g., phenobarbital, diphenylhydantoin, primidone)\n* Anti-psychotics and inhibitors of dopamine uptake (e.g. haloperidol, DOPA, tricyclic antidepressants)\n* Concomitant medication that could prolong ECG QT interval (e.g. ondansetron, risperidone, methadone)\n* Selective Serotonin Reuptake Inhibitors (citalopram, sertraline, fluvoxamine, escitalopram)\n* Selective Norepinephrine Uptake Inhibitors (e.g. venlafaxine, duloxetine); Serotonergic Drugs (e.g. dextromethorphan, fentanyl, St. John's Wort, tramadol, 5-hydroxytryptophan); serotonin 5-HT1 receptor agonists (triptans) and 5-HT3 receptor antagonist antiemetics due risk of Serotonin Syndrome which is a potentially life- threatening condition\n* Currently engaged in psychotherapy for CNP (other psychotherapy for non-CNP is allowed).\n* Any other clinically significant medical illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study."}, 'identificationModule': {'nctId': 'NCT07301632', 'acronym': 'EASEPain', 'briefTitle': 'Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Ecstasy to Alleviate SEvere Chronic Neuropathic Pain (EASE Pain) Trial: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'EASE Pain P-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '3,4-Methylenedioxymethamphetamine', 'description': 'Treatment Arm: 3,4-Methylenedioxymethamphetamine 120mg (3 x 40mg capsule) PO single dose plus psychological support; optional 40mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose 160mg)', 'interventionNames': ['Drug: 3,4-Methylenedioxymethamphetamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Methylphenidate', 'description': 'Placebo arm: Methylphenidate 30mg (3 x 10mg capsule) PO single dose plus psychological support; optional 10mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose of 40 mg)', 'interventionNames': ['Drug: Methylphenidate']}], 'interventions': [{'name': '3,4-Methylenedioxymethamphetamine', 'type': 'DRUG', 'otherNames': ['MDMA'], 'description': 'Treatment arm: 3,4-Methylenedioxymethamphetamine 120mg (3 x 40mg capsule) PO single dose plus psychological support; optional 40mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose 160mg)', 'armGroupLabels': ['3,4-Methylenedioxymethamphetamine']}, {'name': 'Methylphenidate', 'type': 'DRUG', 'otherNames': ['MDP'], 'description': 'Placebo arm: Methylphenidate 30mg (3 x 10mg capsule) PO single dose plus psychological support; optional 10mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose of 40 mg)', 'armGroupLabels': ['Methylphenidate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Akash Goel, MD,MPH,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Akash Goel, MD,MPH,FRCPC', 'role': 'CONTACT', 'email': 'Akash.Goel@unityhealth.to', 'phone': '4168645071'}], 'overallOfficials': [{'name': 'Akash Goel, MD,MPH,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}