Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04892251
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2021-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine Assisted Psychotherapy for Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-14', 'mcpReleaseN': 3, 'releaseDate': '2025-03-26'}], 'estimatedResultsFirstSubmitDate': '2025-03-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Drug cue-reactivity', 'timeFrame': 'From baseline to immediately after the 8 week intervention.', 'description': 'Change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.'}, {'measure': 'Emotion regulation', 'timeFrame': 'From baseline to immediately after the 8 week intervention.', 'description': 'Change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.'}, {'measure': 'Theta oscillations', 'timeFrame': 'From baseline to immediately after the 8 week intervention.', 'description': 'Theta oscillations as measured by EEG during meditation'}], 'primaryOutcomes': [{'measure': 'Drug use', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Days of drug use as measured by the Timeline Followback Procedure'}], 'secondaryOutcomes': [{'measure': 'MOUD use', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Days of MOUD use as measured by the Timeline Followback Procedure'}, {'measure': 'Emotional Distress', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.'}, {'measure': 'Meaning in life', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Meaning in life measured by the Meaning in Life Questionnaire, Presence Subscale, range from 5 to 35, higher scores indicating more meaning in life.'}, {'measure': 'Opioid craving', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving.'}, {'measure': 'Self-transcendence', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence.'}, {'measure': 'Affect', 'timeFrame': 'From baseline to 1-month follow-up', 'description': 'Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states.'}, {'measure': 'Mindfulness', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness.'}, {'measure': 'Reappraisal', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal.'}, {'measure': 'Savoring', 'timeFrame': 'From baseline to 3-month follow-up', 'description': 'Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.'}, {'measure': 'Momentary craving', 'timeFrame': 'From baseline to 1-month follow-up', 'description': 'Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.', 'detailedDescription': 'The purpose of this study is to conduct a Stage 1 randomized controlled trial to test a potential optimization of the evidence-based Mindfulness-Oriented Recovery Enhancement (MORE) intervention for opioid use disorder (OUD). Here we will add Ketamine to MORE (MORE+KAP) and test the MORE+KAP intervention versus the standard MORE intervention in a sample of patients receiving medications for OUD (MOUD; e.g, buprenorphine). The primary aim to is evaluate the extent to which MORE+KAP improves OUD treatment relative to MORE. The secondary aim is to identify the psychobiological mediators of MORE+KAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Opioid Use Disorder\n2. Receiving OUD treatment with a buprenorphine formulation\n\nExclusion Criteria:\n\n1. Previous experience with a mindfulness-based intervention program\n2. Pregnancy\n3. Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program\n4. Prior use of ketamine other than as prescribed by a physician\n5. Any of the following medical conditions\n\nBlood Vessel Disease Heart Valve Disease Heart Failure Class 2 or Above Heart Disease Pregnancy/Breastfeeding Arteriovenous Malformation History of Intracranial Bleeding or Stroke History of Seizures Hypoxia defined by current need for supplemental oxygen Liver Disease History of allergic reaction to Ketamine Dementia (moderate-severe) History of Psychotic Disorder, Bipolar Disorder, or Personality Disorder Dissociative Identity Disorder'}, 'identificationModule': {'nctId': 'NCT04892251', 'briefTitle': 'Ketamine Assisted Psychotherapy for Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Ketamine Assisted Psychotherapy for Opioid Use Disorder', 'orgStudyIdInfo': {'id': 'IRB_00130630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MORE+KAP', 'description': '8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions', 'interventionNames': ['Combination Product: MORE+KAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MORE', 'description': '8 weeks of Mindfulness-Oriented Recovery Enhancement', 'interventionNames': ['Behavioral: MORE']}], 'interventions': [{'name': 'MORE+KAP', 'type': 'COMBINATION_PRODUCT', 'description': 'Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly', 'armGroupLabels': ['MORE+KAP']}, {'name': 'MORE', 'type': 'BEHAVIORAL', 'description': 'Mindfulness-Oriented Recovery Enhancement', 'armGroupLabels': ['MORE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'email': 'KetaMORE@utah.edu'}], 'facility': 'Center on Mindfulness and Integrative Health Intervention Development', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'email': 'eric.garland@socwk.utah.edu', 'phone': '801-581-3826'}], 'overallOfficials': [{'name': 'Eric L Garland', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eric Garland', 'investigatorAffiliation': 'University of Utah'}}}}