[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04892251":3,"trial-entities:NCT04892251":111,"trial-summary:NCT04892251":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":14,"eligibility_criteria":79,"std_ages":83,"locations":86,"central_contacts":101,"overall_officials":105,"references":109,"see_also_links":110},"NCT04892251","IRB_00130630","Ketamine Assisted Psychotherapy for Opioid Use Disorder","RECRUITING","2024-05-30","2023-07","2023-07-05","2021-05-20","University of Utah","OTHER",false,"This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.","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.",[18],"Opioid-use Disorder",[],"INTERVENTIONAL","TREATMENT",[23,24],"PHASE1","PHASE2",{"count":26,"type":27},60,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"COMBINATION_PRODUCT","MORE+KAP","Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg\u002Fkg of ketamine are administered intramuscularly",[31],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","MORE","Mindfulness-Oriented Recovery Enhancement",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Drug use","Days of drug use as measured by the Timeline Followback Procedure","From baseline to 3-month follow-up",[45,48,51,54,57,60,64,67,70,73],{"measure":46,"description":47,"timeFrame":43},"MOUD use","Days of MOUD use as measured by the Timeline Followback Procedure",{"measure":49,"description":50,"timeFrame":43},"Emotional Distress","Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.",{"measure":52,"description":53,"timeFrame":43},"Meaning in life","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":55,"description":56,"timeFrame":43},"Opioid craving","Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving.",{"measure":58,"description":59,"timeFrame":43},"Self-transcendence","Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence.",{"measure":61,"description":62,"timeFrame":63},"Affect","Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states.","From baseline to 1-month follow-up",{"measure":65,"description":66,"timeFrame":43},"Mindfulness","Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness.",{"measure":68,"description":69,"timeFrame":43},"Reappraisal","Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal.",{"measure":71,"description":72,"timeFrame":43},"Savoring","Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.",{"measure":74,"description":75,"timeFrame":63},"Momentary craving","Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.","ALL","18 Years",null,{"inclusion":80,"exclusion":81,"raw_text":82},[],[],"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\u002FBreastfeeding 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",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":98},"Center on Mindfulness and Integrative Health Intervention Development","Salt Lake City","Utah","84112","United States",[94],{"name":95,"role":96,"email":97},"Research Coordinator","CONTACT","KetaMORE@utah.edu",{"lat":99,"lon":100},40.76078,-111.89105,[102],{"name":95,"role":96,"phone":103,"email":104},"801-581-3826","eric.garland@socwk.utah.edu",[106],{"name":107,"affiliation":12,"role":108},"Eric L Garland","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Opioid Use Disorder",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":126},true,{"design":118,"status":119,"heading":6,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a randomized controlled trial planning to enroll 60 participants. It compares two different interventions for Opioid Use Disorder.","completed","This study is testing if adding ketamine to a therapy called Mindfulness-Oriented Recovery Enhancement (MORE) can help people with Opioid Use Disorder (OUD). You could be eligible if you have OUD and are currently receiving treatment with buprenorphine. The study will compare two groups: one receiving MORE therapy alone, and another receiving MORE therapy plus two sessions where ketamine (0.5 to 1.5 mg\u002Fkg) is given as a shot. The main goal is to see if the combination therapy reduces drug use over a three-month period. The current status of this study is unclear.","Participants will be followed for drug use from the beginning of the study up to a 3-month follow-up.",93,"Not specified in the trial record.","Not stated in the trial record.",[36],"v2"]