[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441404":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":40,"locations":45,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":22,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":22,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":22,"overallStatus":47,"whyStopped":22,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Within-subject design","All participants will undergo the same study design, which includes hydromorphone stabilization (days 1-5), two naloxone challenges (scheduled during morphine stabilization), lofexidine-assisted taper (days 6-10), and transition to aftercare (day 11).",[12,13,14,15],"Drug: Hydromorphone","Drug: Naloxone + lofexidine pretreatment","Drug: Naloxone + placebo pretreatment","Drug: Lofexidine",[17,23,27,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Hydromorphone","Up to 120mg oral per day in q4 dosing to manage withdrawal",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Naloxone + lofexidine pretreatment","0.2-0.4mg naloxone injection during the Naloxone challenge + pretreatment with oral lofexidine (25% of max daily dose scheduled during lofexidine taper)",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Naloxone + placebo pretreatment","0.2-0.4mg naloxone injection during the Naloxone challenge",[9],{"type":18,"name":32,"description":33,"armGroupLabels":34,"otherNames":22},"Lofexidine","Oral Lofexidine dosed per FDA label (4 times daily) on days 6 through 10.",[9],[36],{"name":37,"affiliation":38,"role":39},"Kelly E Dunn, Ph.D, M.B.A.","University of Maryland","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":22,"email":44},"CONTACT","802-922-1682","kelly.dunn@som.umaryland.edu",[46],{"facility":38,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-76.61219,39.29038,{"lat":57,"lon":56},[60,62],{"name":61,"role":42,"phone":43,"phoneExt":22,"email":44},"Kelly E Dunn, PhD, MBA",{"name":61,"role":39,"phone":22,"phoneExt":22,"email":22},{"type":64,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[66],{"name":67,"class":68},"National Institute on Drug Abuse (NIDA)","NIH","100441404","phase-2-assessing-a-clinically-meaningful-opioid-withdrawal-phenotype-100441404",false,"NCT05027919","Assessing a Clinically-meaningful Opioid Withdrawal Phenotype","Inclusion Criteria:\n\n* 18 years - 65 year old\n* Opioid-positive urine sample\n* Current opioid use disorder with evidence of physical dependence\n* Interest in undergoing opioid taper\n\nExclusion Criteria:\n\n* Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention\n* Being pregnant or breastfeeding\n* Enrolled in methadone or buprenorphine maintenance treatment\n* Clinically significant hypotension (\\\u003C90\u002F60mmHg) or bradycardia (\\\u003C45bpm)\n* History of myocardial infarction\n* Subjects who are positive for hepatitis B surface antigen and\u002For hepatitis C antibody with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study)\n* Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation","ALL","18 Years","65 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.",[86,87,88],"Opioid Withdrawal","Opioid Use Disorder","Opioid Craving","2025-09-05",{"date":91,"type":92},"2025-09-12","ACTUAL",{"date":94,"type":92},"2021-12-01",{"date":96,"type":80},"2027-02-28",{"name":5,"class":6},1]