[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06355778":3,"trial-entities:NCT06355778":122,"trial-summary:NCT06355778":125},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":66,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":95,"locations":97,"central_contacts":114,"overall_officials":117,"references":120,"see_also_links":121},"NCT06355778","HUM00234185","Adversity, Brain and Opioid Use Study","A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences","RECRUITING","2028-04","2025-12","2026-07-17","2025-01-09","University of Michigan","OTHER",null,"The way people process and remember information may be related to adverse childhood experiences and Opioid Use Disorder symptoms. The purpose of this project is to examine brain function and performance during learning and memory tasks in adults. The study will compare measures of learning and memory across three groups of participants: those with an Opioid Use Disorder (OUD) that take buprenorphine for opioid replacement therapy, adults without an Opioid Use Disorder taking buprenorphine, and healthy adults that do not have an Opioid Use Disorder and are not taking buprenorphine.",[18,19],"Opioid Use Disorder","Healthy",[21,22,23,24,25],"Magnetic Resonance Imaging (MRI)","Adverse Childhood Experiences","Fear Learning","Memory","Hippocampal function","INTERVENTIONAL","BASIC_SCIENCE",[29],"NA",{"count":31,"type":32},185,"ESTIMATED",[34,40],{"type":14,"name":21,"description":35,"armGroupLabels":36},"Enrolled participants will have one MRI during the study on day 2 after having Day 1 visit. During the MRI the participants will complete various tasks.",[37,38,39],"Buprenorphine (BUP) control group:","Healthy Controls group","Opioid use disorder (OUD) group",{"type":41,"name":42,"description":43,"armGroupLabels":44},"BEHAVIORAL","Computer Tasks","Eligible participants will complete computer tasks (cognitive tasks, spatial navigation tasks, context dependent fear learning, etc.) at visit 1 and then during the MRI.",[37,38,39],[46,50,53,56,60,61,64],{"measure":47,"description":48,"timeFrame":49},"Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus","BOLD signal during functional magnetic resonance imaging (fMRI) will be used as a measure of hippocampus activation when remembering common objects and scenes. The study team will examine differences between participants with Opioid Use Disorder (OUD) and those without OUD.","Day 2 (MRI task visit)",{"measure":51,"description":52,"timeFrame":49},"Differences in Hippocampal (Hpc) volume","T-1 weighted structural images for each participant will be used to compute the volume of the hippocampus in people with OUD compared to those without OUD.",{"measure":54,"description":55,"timeFrame":49},"Differences in hippocampal circuit connectivity","Functional connectivity, measured with BOLD signal will be used to examine functional connectivity between the hippocampus, amygdala, and prefrontal cortex. The study team will examine differences in connectivity between participants with OUD and those without OUD.",{"measure":57,"description":58,"timeFrame":59},"Differences in performance","Number of correct responses will be used to assess memory for common objects and scenes. Differences in memory will be examined in between participants with OUD and those without OUD.","Day 1 (computer tasks visit)",{"measure":57,"description":58,"timeFrame":49},{"measure":62,"description":63,"timeFrame":59},"Differences in threat reactivity measured via skin conductance response (SCR)","Electrodermal activity collected with a bioamplifier will be used to quantify physiological reactivity to threat. Event related SCR will be measured as a baseline corrected response (peak minus baseline) to cues that predict threat compared to cues that do not predict threat. Differences in SCR between participants with OUD and participants without OUD will be examined.",{"measure":62,"description":65,"timeFrame":49},"Electrodermal activity collected with a bioamplifier will be used to quantify physiological reactivity to threat. Event related SCR will be measured as a baseline corrected response (peak minus baseline) to cues that predicted threat on the previous day compared to cues that did not predict threat. Differences in SCR between participants with OUD and participants without OUD will be examined.",[],"ALL","18 Years","55 Years",true,{"inclusion":72,"exclusion":84,"raw_text":94},[73,74,75,76,77,78,79,80,81,79,82,83],"Fluent in English","Able to give informed consent","Normal\u002Fcorrected-to-normal vision and hearing","Diagnosis of OUD","Be actively receiving buprenorphine (BUP) for opioid agonist therapy","Be free from illicit substance use for at least 2 weeks","The study will allow stable dose (\\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)","Taking BUP for chronic pain","No Substance Use Disorder (including OUD)","Not taking BUP","Free of any psychiatric or major medical conditions",[85,86,87,88,89,90,91,92,93],"Pregnancy","Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis)","Actively suicidal","Contraindication for MRI","Inability to tolerate small, enclosed spaces without anxiety or unable to fit comfortably in the MRI scanner","Life history of schizophrenia, learning disability, attention deficit disorder, or pervasive developmental disorder","Use of substances or prescription medications that could interfere with measures of interest (per protocol)","Unable to provide informed consent","Participants who have completed other studies in our lab involving learning and memory assessments with the same\u002Fsimilar tasks used here (HUM00230585, HUM00121812) will not be eligible to complete the current study, due to possible learning\u002Fpractice effects","Inclusion Criteria for all groups:\n\n* Fluent in English\n* Able to give informed consent\n* Normal\u002Fcorrected-to-normal vision and hearing\n\nInclusion Criteria for Opioid Use Disorder (OUD) group:\n\n* Diagnosis of OUD\n* Be actively receiving buprenorphine (BUP) for opioid agonist therapy\n* Be free from illicit substance use for at least 2 weeks\n* The study will allow stable dose (\\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)\n\nInclusion Criteria for the BUP control group:\n\n* Taking BUP for chronic pain\n* No Substance Use Disorder (including OUD)\n* The study will allow stable dose (\\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)\n\nInclusion Criteria for Healthy participant group:\n\n* Not taking BUP\n* Free of any psychiatric or major medical conditions\n\nExclusion Criteria for all groups:\n\n* Pregnancy\n* Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis)\n* Actively suicidal\n* Contraindication for MRI\n* Inability to tolerate small, enclosed spaces without anxiety or unable to fit comfortably in the MRI scanner\n* Life history of schizophrenia, learning disability, attention deficit disorder, or pervasive developmental disorder\n* Use of substances or prescription medications that could interfere with measures of interest (per protocol)\n* Unable to provide informed consent\n* Participants who have completed other studies in our lab involving learning and memory assessments with the same\u002Fsimilar tasks used here (HUM00230585, HUM00121812) will not be eligible to complete the current study, due to possible learning\u002Fpractice effects",[96],"ADULT",[98],{"facility":13,"status":8,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":111},"Ann Arbor","Michigan","48109","United States",[104,108],{"name":105,"role":106,"email":107},"Aml Almamri","CONTACT","AdversityBrainOUD@med.umich.edu",{"name":109,"role":110},"Elizabeth Duval, PhD","PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},42.27756,-83.74088,[115],{"name":105,"role":106,"phone":116,"email":107},"734-232-0190",[118],{"name":119,"affiliation":13,"role":110},"Elizabeth Duval",[],[],{"nct_id":4,"conditions":123,"biomarkers":124},[19,18],[],{"nct_id":4,"found":70,"summary":126,"prompt_version":136},{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This interventional study plans to enroll 185 participants across three groups. It is not specified if the study is randomized or blinded.","completed","Adversity, Brain, and Opioid Use Study","This study is looking at how the brain processes and remembers information, especially in relation to past difficult experiences and Opioid Use Disorder (OUD). Researchers want to understand brain function and performance during learning and memory tasks. You might be eligible if you are between 18 and 55 years old, speak English fluently, and have normal vision and hearing. The study is comparing three groups: people with OUD who are taking buprenorphine, people without OUD who are taking buprenorphine, and healthy adults who are not taking buprenorphine. The main goals are to see differences in brain activity (Blood Oxygen Level Dependent or BOLD signal), brain volume, and brain connections in a specific area called the hippocampus. The current recruitment status is unclear.","The primary measurements are taken on Day 2 (MRI task visit).",122,"You would have two visits. On Day 1, you would complete computer tasks. On Day 2, you would have an MRI scan while completing various tasks.","Not stated in the trial record.",[],"v2"]