Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-02 @ 5:20 AM
Study NCT ID:
NCT06692192
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The RECAP2 Study: Midazolam and Psilocybin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011562', 'term': 'Psilocybin'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)', 'timeFrame': 'Baseline to 7 days post-dose', 'description': 'WEMWBS is a 14-item questionnaire in which participants describe their experience of each item. It is scored on a 5-point Likert scale, possible range of 14-70 where higher scores indicate higher levels of wellbeing.'}, {'measure': 'Change in Brief Experiential Avoidance Questionnaire (BEAQ)', 'timeFrame': 'Baseline to 7 days post-dose', 'description': 'The BEAQ is a 15-item questionnaire assessing participants agreement with wellbeing statements. It is scored on a 6-point Likert scale, ranging from 15-90 with higher scores indicating a greater tendency towards experiential avoidance'}, {'measure': 'Change in Probabilistic Reversal Learning (PRL)', 'timeFrame': 'Baseline to 7 days post-dose', 'description': 'Participants are presented with two stimuli or options and learn which one is more likely to be associated with a reward based on feedback after each trial. After a certain number of trials, the reward contingencies are reversed, meaning the previously advantageous option becomes less likely to be rewarded, and vice versa. The task assesses how quickly and effectively individuals can adapt to these changes in reward contingencies. Researchers analyze various performance metrics, such as the speed of reversal, the number of errors, and the patterns of choices (e.g., win-stay, lose-shift).'}, {'measure': 'Change in transcranial magnetic stimulation evoked potential (TEP) amplitude', 'timeFrame': 'Baseline to 7 days post-dose', 'description': 'TEP measures neural excitability in the stimulated region of the brain.'}], 'secondaryOutcomes': [{'measure': 'Change in WEMWBS', 'timeFrame': 'Baseline to 28 days post-dose', 'description': 'WEMWBS is a 14-item questionnaire in which participants describe their experience of each item. It is scored on a 5-point Likert scale, possible range of 14-70 where higher scores indicate higher levels of wellbeing.'}, {'measure': 'Change in BEAQ', 'timeFrame': 'Baseline to 28 days post-dose', 'description': 'The BEAQ is a 15-item questionnaire assessing participants agreement with wellbeing statements. It is scored on a 6-point Likert scale, ranging from 15-90 with higher scores indicating a greater tendency towards experiential avoidance'}, {'measure': 'Change in PRL', 'timeFrame': 'Baseline to 28 days post-dose', 'description': 'Participants are presented with two stimuli or options and learn which one is more likely to be associated with a reward based on feedback after each trial. After a certain number of trials, the reward contingencies are reversed, meaning the previously advantageous option becomes less likely to be rewarded, and vice versa. The task assesses how quickly and effectively individuals can adapt to these changes in reward contingencies. Researchers analyze various performance metrics, such as the speed of reversal, the number of errors, and the patterns of choices (e.g., win-stay, lose-shift).'}, {'measure': 'Change in TEP amplitude', 'timeFrame': 'Baseline to 28 days post-dose', 'description': 'TEP measures neural excitability in the stimulated region of the brain.'}, {'measure': 'Altered States of Consciousness (ASC) questionnaire', 'timeFrame': 'Dosing 1 day', 'description': 'Participants will complete a selection of several questions from the ASC questionnaire that strongly associate positively or negatively with later antidepressant effect of psilocybin in patients with treatment resistant depression or capture classic features of the psychedelic experience. During the dosing session, investigator will repeatedly ask selected items from the ASC scale to get a "real time" measure of what the participants are experiencing. Each of these items will be scored separately. Higher score are indicative of a more intense psychedelic experience.'}, {'measure': 'Emotional Breakthrough Inventory (EBI)', 'timeFrame': 'Dosing 1 day', 'description': "The EBI is a 6-item scale that assesses the presence and severity of emotionally challenging/distressing experiences that occur during a psychedelic experience. Participants rate to what extent the statements apply to their experience by marking a single line across each scale. Scale ranges from not at all to very much so. Higher scores (more slashes toward the 'very much so' end) on the scale have been associated with enhanced well-being following psychedelic use"}, {'measure': 'Psychological Insight Questionnaire (PIQ)', 'timeFrame': 'Dosing 1 day', 'description': 'The PIQ is a 23-item instrument designed to query self-perceived attainment of insight during a psychedelic medicine session. Items are rated on a 6-point Likert scale, 0 = no not at all and 5 = extremely. Possible scares range from 0-115, with higher scores indicating greater insight.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sub-optimal wellbeing'], 'conditions': ['Psilocybin']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.\n\nResearchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.\n\nParticipants will:\n\n* Receive one of four possible combinations of medications\n* Undergo an MRI\n* Complete questionnaires\n* Undergo transcranial magnetic stimulation (TMS) and EEG", 'detailedDescription': 'The purpose of this study is to investigate the role that inducing neuroplasticity plays in the behavioral effects of psilocybin in people with modest decrements in emotional wellbeing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 65 years at screening, of any identified gender and racial/ethnic group\n* Physically healthy; does not meet criteria for an exclusionary medical condition\n* English-speaking (able to provide consent and complete questionnaires)\n* Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder\n* Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)\n\nExclusion Criteria:\n\n* Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation\n* Exclusionary medical conditions\n* Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)\n* Clinically significant electrocardiogram (ECG)\n* Use of psychotropic or CNS-altering medications within 3 months of screening\n* Hypertension or tachycardia'}, 'identificationModule': {'nctId': 'NCT06692192', 'briefTitle': 'The RECAP2 Study: Midazolam and Psilocybin', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': "Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)", 'orgStudyIdInfo': {'id': '2024-0852'}, 'secondaryIdInfos': [{'id': 'A538900', 'type': 'OTHER', 'domain': 'UW- Madison'}, {'id': 'SMPH/PSYCHIATRY/PSYCHIATRY', 'type': 'OTHER', 'domain': 'UW- Madison'}, {'id': 'Protocol Version 12/12/2025', 'type': 'OTHER', 'domain': 'UW- Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Psilocybin and intravenous (IV) midazolam', 'description': 'Psilocybin (25 mg) + IV midazolam', 'interventionNames': ['Drug: Psilocybin', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Psilocybin and IV saline', 'description': 'Psilocybin (25 mg) + IV saline (placebo for midazolam)', 'interventionNames': ['Drug: Psilocybin', 'Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Psilocybin and IV midazolam', 'description': 'Psilocybin (1 mg/control) + IV midazolam', 'interventionNames': ['Drug: Psilocybin', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Psilocybin and IV saline', 'description': 'Psilocybin (1 mg/control) + IV saline', 'interventionNames': ['Drug: Psilocybin', 'Drug: Saline']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'otherNames': ['Psilocybine', 'Psilocibin'], 'description': '25mg of psilocybin', 'armGroupLabels': ['Group 1: Psilocybin and intravenous (IV) midazolam', 'Group 2: Psilocybin and IV saline']}, {'name': 'Psilocybin', 'type': 'DRUG', 'otherNames': ['Psilocybine', 'Psilocibin'], 'description': '1mg of psilocybin', 'armGroupLabels': ['Group 3: Psilocybin and IV midazolam', 'Group 4: Psilocybin and IV saline']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session.', 'armGroupLabels': ['Group 1: Psilocybin and intravenous (IV) midazolam', 'Group 3: Psilocybin and IV midazolam']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Saline will be administered as a placebo for midazolam', 'armGroupLabels': ['Group 2: Psilocybin and IV saline', 'Group 4: Psilocybin and IV saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UW School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'RECAP Study Contact', 'role': 'CONTACT', 'email': 'recap2@psychiatry.wisc.edu', 'phone': '608-263-4852'}], 'overallOfficials': [{'name': 'Charles Raison, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vail Health Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}