[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04166071":3,"trial-entities:NCT04166071":91,"trial-summary:NCT04166071":94},{"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":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":68,"locations":70,"central_contacts":84,"overall_officials":85,"references":89,"see_also_links":90},"NCT04166071","SSO","Opioids and Social Support Enhanced Extinction Effects","Revisiting Safety Signals: Examining a Separate Safety Mechanism for Social Support Figures","ENROLLING_BY_INVITATION","2026-09","2025-10","2025-10-20","2021-12-13","University of California, Los Angeles","OTHER",false,"University of California, Los Angeles researchers will recruit healthy participants (age 18-35) to participate in a study examining whether the administration of naltrexone, an opioid antagonist, eliminates the ability of social support figure reminders to enhance fear extinction--a process during which a threatening cue is learned to not predict a negative or threatening outcome (i.e., electric shock) by being repeatedly presented in the absence of that outcome.\n\nAfter undergoing an email screening, a telephone screening, an in lab screening, and a health screening, 60 participants will be enrolled in the study. During the experiment, 30 participants will be administered naltrexone and 30 participants will be administered placebo (both participants and experimenters will be blind to condition) before undergoing a fear extinction procedure in which threatening cues--cues that predict electric shock--will be paired with either an image of a social support figure (provided by participants) or a second threatening cue. These pairings will be presented repeatedly in the absence of shock in order for fear extinction to occur. Participants will return for a follow-up test to determine if fear extinction was successful.",null,[19],"Fear",[21,22],"social support","fear extinction","INTERVENTIONAL","BASIC_SCIENCE",[26],"EARLY_PHASE1",{"count":28,"type":29},60,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Naltrexone","Half of the participants will be randomly assigned to take one dose of naltrexone (50mg, capsule form) during the experimental session",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Placebo","Half of the participants will be randomly assigned to take a placebo capsule during the experimental session",[37],[41,45],{"measure":42,"description":43,"timeFrame":44},"Fear Response directly post-extinction","presence of fear response as indicated by significantly higher galvanic skin response (GSR: an index of peripheral stress responding) to a previously learned fearful image (CS+) compared to a baseline comparator (CS-: never learned to be fearful).","Directly following a fear extinction procedure (during the experiment session).",{"measure":46,"description":43,"timeFrame":47},"Fear Response 24-hours post-extinction","24 hours following the completion of the fear extinction procedure (during a follow-up fear reinstatement session).",[],"ALL","18 Years","35 Years",true,{"inclusion":54,"exclusion":58,"raw_text":67},[55,56,57],"healthy adults 18 and 35","fluent in English","no history of mental illness (including anxiety, depression, phobia, or any other mental health related disorder diagnosed by a mental health professional)",[59,60,61,62,63,64,65,66],"pregnant or planning to become pregnant during the experiment period","presence of chronic mental illness (as determined by the report of a past diagnosis of mental illness by a physician or psychologist and\u002For the prescription of medication related to mental health disorder; including anxiety, depression, phobia, or any other diagnosed psychological disorder)","chronic physical illness (as determined by past diagnosis and\u002For treatment by a physician)","history of liver disease or abnormal liver function","current and regular use of prescription medications related to mental health disorders or liver function","previous history of fainting during blood draws","difficulty or discomfort swallowing pills","history of substance abuse or addiction (especially alcohol or opiate abuse)","Inclusion Criteria:\n\n* healthy adults 18 and 35\n* fluent in English\n* no history of mental illness (including anxiety, depression, phobia, or any other mental health related disorder diagnosed by a mental health professional)\n\nExclusion Criteria:\n\n* pregnant or planning to become pregnant during the experiment period\n* presence of chronic mental illness (as determined by the report of a past diagnosis of mental illness by a physician or psychologist and\u002For the prescription of medication related to mental health disorder; including anxiety, depression, phobia, or any other diagnosed psychological disorder)\n* chronic physical illness (as determined by past diagnosis and\u002For treatment by a physician)\n* history of liver disease or abnormal liver function\n* current and regular use of prescription medications related to mental health disorders or liver function\n* previous history of fainting during blood draws\n* difficulty or discomfort swallowing pills\n* history of substance abuse or addiction (especially alcohol or opiate abuse)\n\nOther exclusion criteria may apply.",[69],"ADULT",[71,80],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"UCLA Department of Psychology, 5514 Pritzker Hall","Los Angeles","California","90095-1563","United States",{"lat":78,"lon":79},34.05223,-118.24368,{"facility":81,"city":73,"state":74,"zip":82,"country":76,"geoPoint":83},"UCLA","90095",{"lat":78,"lon":79},[],[86],{"name":87,"affiliation":13,"role":88},"Naomi Eisenberger, Ph.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":93},[19],[],{"nct_id":4,"found":52,"summary":95,"prompt_version":105},{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an interventional study with 60 participants. Half will randomly receive naltrexone and the other half a placebo.","completed","Study on Naltrexone and Social Support for Fear Response","This study at UCLA is looking for healthy adults aged 18-35 to understand how a medication called naltrexone affects our ability to overcome fear, especially when we have social support. Naltrexone is a drug that blocks the effects of opioids in the body. Researchers want to see if naltrexone stops social support from helping people learn to not be afraid of something that was once threatening (this process is called fear extinction). Half of the participants will receive a single dose of naltrexone, and the other half will receive a placebo (an inactive pill). The study will measure fear responses immediately after a fear extinction procedure and again 24 hours later. They plan to enroll 60 participants, but the current recruitment status is unclear.","Your fear response will be measured directly after the fear extinction procedure and again 24 hours later.",124,"You will go through email, telephone, in-lab, and health screenings. During the experiment, you will take a capsule and participate in a fear extinction procedure, with a follow-up session 24 hours later.","Not stated in the trial record.",[33,37],"v2"]