[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07158853":3,"trial-entities:NCT07158853":89,"trial-summary:NCT07158853":92},{"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":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":45,"std_ages":63,"locations":66,"central_contacts":81,"overall_officials":83,"references":87,"see_also_links":88},"NCT07158853","PSYCH-2025-34164","Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder","RECRUITING","2027-08-31","2026-07","2026-07-06","2026-02-04","University of Minnesota","OTHER",false,"The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).",null,[18],"Opioid Use Disorder",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE1",{"count":25,"type":26},40,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Transcranial Direct Current Stimulation (tDCS)","We will deliver 2-mA tDCS current intensity during a 30 minute stimulation period (including a 30-second ramp-up and 30-second ramp-down period) to the dorsolateral prefrontal cortex. Electrodes will be fixed on marked locations based on the 10-20 EEG system. Anodal stimulating electrode will be over the left DLPFC (F3) and cathodal electrode over the right DLPFC (F4).",[33],"tDCS",[35,39],{"measure":36,"description":37,"timeFrame":38},"tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network","To assess changes in target engagement, we will measure the change in resting-state functional connectivity (measured as a Pearson correlation coefficient, r) between the prefrontal cortex and the incentive salience network from pre- to post-intervention using a paired t-test. The connectivity metric ranges from a minimum value of -1.0 (perfectly negative correlation) to a maximum value of 1.0 (perfectly positive correlation). Higher scores indicate stronger functional connectivity (greater top-down regulation), representing a better outcome.","immediately after the intervention",{"measure":40,"description":41,"timeFrame":38},"tDCS effect on executive functioning","To assess changes in executive functioning, we will measure the change in executive functioning from pre- to post-intervention using a repeated measures t-test. Cognitive performance will be assessed via a behavioral battery spanning cognitive flexibility, working memory, inhibitory control, and delay discounting (utilizing standardized Pearson assessments and a computerized delay discounting task). Performance metrics across tasks will be converted to standardized z-scores (typically ranging from -3.0 to +3.0). The primary endpoint is the post-intervention mean z-score minus the pre-intervention mean z-score. A positive change score indicates an increase in executive functioning, representing a better clinical outcome.",[],"ALL","18 Years",{"inclusion":46,"exclusion":51,"raw_text":62},[47,48,49,50],"Ability to provide consent and comply with study procedures","Diagnostic and Statistical Manual of Mental Disorders criteria for OUD","Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD","Intention to remain in the study until intervention completion.",[52,53,54,55,56,57,58,59,60,61],"Any medical condition with neurological sequelae","Head injury resulting in skull fracture or loss of consciousness of \\>30 minutes","Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates\u002Fscrews or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia)","Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included)","Presence of a condition that would render study measures impossible to administer or interpret","Age younger than 18","Primary current substance use disorder on a substance other than opioids except for caffeine or nicotine","In treatment instead of jail","Pregnancy","Disrespectful behavior towards the investigators and staff.","Inclusion Criteria:\n\n* Ability to provide consent and comply with study procedures\n* Diagnostic and Statistical Manual of Mental Disorders criteria for OUD\n* Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD\n* Intention to remain in the study until intervention completion.\n\nExclusion Criteria:\n\n* Any medical condition with neurological sequelae\n* Head injury resulting in skull fracture or loss of consciousness of \\>30 minutes\n* Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates\u002Fscrews or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia)\n* Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included)\n* Presence of a condition that would render study measures impossible to administer or interpret\n* Age younger than 18\n* Primary current substance use disorder on a substance other than opioids except for caffeine or nicotine\n* In treatment instead of jail\n* Pregnancy\n* Disrespectful behavior towards the investigators and staff.",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":12,"status":7,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Minneapolis","Minnesota","55455","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Calvin Cahill","CONTACT","952-444-0137","cahil138@umn.edu",{"lat":79,"lon":80},44.97997,-93.26384,[82],{"name":74,"role":75,"phone":76,"email":77},[84],{"name":85,"affiliation":12,"role":86},"Jazmin Camchong, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":91},[18],[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This interventional study plans to enroll 40 participants. It is not specified if it is randomized or blinded.","completed","Combined tDCS and Cognitive Training for Opioid Use Disorder","This study is looking into whether adding Transcranial Direct Current Stimulation (tDCS) and cognitive training can help people who are already taking medication for Opioid Use Disorder (OUD). tDCS is a device that delivers a small electrical current to a specific part of the brain. Researchers want to see if this combination helps improve brain networks related to reward and decision-making, and also executive functioning (skills like planning and problem-solving). You might be able to join if you are 18 or older, have OUD, are currently on OUD medication, and can follow study procedures. The study aims to enroll 40 participants.","The primary endpoints are measured immediately after the intervention.",101,"Participants will receive 30-minute tDCS stimulation sessions. The study measures effects immediately after the intervention.","Not stated in the trial record.",[30],"v2"]