[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06302413":3,"trial-entities:NCT06302413":111,"trial-summary:NCT06302413":115},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":80,"locations":82,"central_contacts":101,"overall_officials":107,"references":109,"see_also_links":110},"NCT06302413","1805574553; Aims 9-10","Enhancing Prospective Thinking in Early Recovery (HOME)","Enhancing Prospective Thinking in Early Recovery","RECRUITING","2027-07-31","2026-03","2026-05-04","2024-02-15","Indiana University","OTHER",true,"The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question\\[s\\] this trial aims to answer are:\n\nWill the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.",null,[19],"Alcohol Use Disorder",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},500,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Virtual Reality","They will receive a Virtual Reality Park experience, which is an empty park with no avatars. They will then have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting.",[31],{"type":30,"name":31,"description":35,"armGroupLabels":36},"They will receive a Virtual Reality Park experience, which is an empty park with no avatars.",[37],"Treatment As Usual",[39,43,47,50,53,56],{"measure":40,"description":41,"timeFrame":42},"Reduced Use of Drug Using Days","The Virtual Reality Avatar experience will reduce drug using days.","Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit",{"measure":44,"description":45,"timeFrame":46},"Increased Length of Abstinence","The Virtual Reality Avatar experience will increase the length of abstinence periods.","Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.",{"measure":48,"description":49,"timeFrame":46},"Increased (overall) Abstinence","The Virtual Reality Avatar experience will increase abstinence.",{"measure":51,"description":52,"timeFrame":42},"Future Self-identification with Future Self Continuity Questionnaire","The Virtual Reality Avatar experience will increase future self-identification.",{"measure":54,"description":55,"timeFrame":46},"Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire","The Virtual Reality Avatar experience will increase future time perspective.",{"measure":57,"description":58,"timeFrame":46},"Delayed Reward Preference with the Delayed Discounting Behavioral Task","The Virtual Reality Avatar experience will increase preference for delayed rewards.",[],"ALL","18 Years","60 Years",false,{"inclusion":65,"exclusion":72,"raw_text":79},[66,67,68,69,70,71],"Abstinence between ≥14 days and ≤1 year","Verbal endorsement of commitment to recovery","Outpatient","Psychotropic drugs for SUD-comorbidity","Drug\u002Falcohol abstinence ≥ 24 hours at the time of the study day visit","English comprehension",[73,74,75,76,77,78],"Unstable medical disorders","Habitual drug use","Mu-opioid drugs","Smell\u002Ftaste disorders","Unstable psychiatric conditions","Extravagant\u002Felaborate face tattoos","Inclusion Criteria:\n\n* Abstinence between ≥14 days and ≤1 year\n* Verbal endorsement of commitment to recovery\n* Outpatient\n* Psychotropic drugs for SUD-comorbidity\n* Drug\u002Falcohol abstinence ≥ 24 hours at the time of the study day visit\n* English comprehension\n\nExclusion Criteria:\n\n* Unstable medical disorders\n* Habitual drug use\n* Mu-opioid drugs\n* Smell\u002Ftaste disorders\n* Unstable psychiatric conditions\n* Extravagant\u002Felaborate face tattoos",[81],"ADULT",[83],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"Indiana University School of Medicine - Goodman Hal","Indianapolis","Indiana","46202","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Sarah Turo, BA","CONTACT","317-963-7220","sturo@iu.edu",{"name":96,"role":97},"Brandon G Oberlin, PhD","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},39.76838,-86.15804,[102,103],{"name":91,"role":92,"phone":93,"email":94},{"name":104,"role":92,"phone":105,"email":106},"Colton Lind, BS","317-963-2554","cmlind@iu.edu",[108],{"name":96,"affiliation":13,"role":97},[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Alcohol use disorder",[],{"nct_id":4,"found":15,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This interventional study plans to enroll 500 participants. It is testing two different virtual reality experiences.","completed","Virtual Reality for Alcohol Use Disorder Recovery","This study is testing a new way to help people recovering from Alcohol Use Disorder (AUD) using Virtual Reality (VR). You would experience a virtual park, sometimes with an avatar (a digital representation of yourself). The researchers want to see if this VR experience can help reduce alcohol use, increase the time you stay sober, and help you think more about your future. They are looking for 500 participants, aged 18 to 60, who have been sober for at least 14 days but less than a year, are committed to recovery, and can understand English. The study will measure changes in alcohol use and abstinence at different times over six months.","Participants will be followed for 6 months after the study day visit.",111,"You would participate in a study day visit, a 30-day follow-up visit, and a 6-month follow-up visit.","Not stated in the trial record.",[31],"v2"]