[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05995535":3,"trial-entities:NCT05995535":118,"trial-summary:NCT05995535":122},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":43,"secondary_outcomes":48,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":107,"overall_officials":115,"references":116,"see_also_links":117},"NCT05995535","854046","Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal","RECRUITING","2026-08-31","2026-01","2026-02-13","2024-01-01","University of Pennsylvania","OTHER",true,"A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine\u002Fpregabalin or lofexidine\u002Fpregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.","A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine\u002Fpregabalin or lofexidine\u002Fpregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal. It follows a UG3 study in which 90 inpatients with an OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with lofexidine\u002Fpregabalin or lofexidine\u002Fplacebo pregabalin. Results were that the conditions were equally safe, and that lofexidine\u002Fpregabalin was more effective in reducing subjective withdrawal and keeping patients in treatment than lofexidine\u002Fplacebo pregabalin.\n\nThe objectives are to study the safety and effectiveness of lofexidine\u002Fpregabalin compared to lofexidine\u002Fplacebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient settings.",[18,19],"Opiate Withdrawal Syndrome","Opioid Use",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},150,"ESTIMATED",[29,38],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","LFX\u002FPGB","lofexidine tablets 0.18mg tabs\n\npregabalin capsules 100mg and 25mg",[31,34],"LFX\u002FPLA-PGB",[36,37],"Lucemyra","lyrica",{"type":30,"name":34,"description":39,"armGroupLabels":40,"otherNames":41},"lofexidine tablets 0.18mg tabs\n\npregabalin capsules 0mg",[31,34],[36,42],"placebo pregabalin",[44],{"measure":45,"description":46,"timeFrame":47},"Subjective Opioid Withdrawal Scale (SOWS) scores","Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal\u002F30 = severe withdrawal","10 days per subject, through study completion (N=150)",[49,52],{"measure":50,"description":51,"timeFrame":47},"Study detox completion","Proportion that receives one or more doses of study medication and completed withdrawal (Completing withdrawal management will be defined as having received at least 1 dose of study medication on day 8 and completing the SOWS-Gossop assessment on day 8); and proportion that transition to XR-NTX; adverse events",{"measure":53,"description":54,"timeFrame":55},"XR-NTX IM injection","proportion that receives 380mg dose of extended-release naltrexone","upto 2 days per subject (N=150)","ALL","18 Years",null,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\n1. Male and\u002For female subjects ≥ 18 years of age\n2. Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have met 2 or more of the 11 criteria for an OUD including tolerance and withdrawal within the last 12 months\n3. Interested in opioid antagonist treatment\n4. Used opioids in 20 or more of the last 30 days\n5. A stable address in the local area; not planning to move in the next 60 days.\n6. Have documents for ID check\n7. Absence of medical or psychiatric conditions that are likely to interfere with study participation\n8. Has 12 lead ECG demonstrating a QTc ≤450 msec and a QRS ≤120 msec. Site PI has final determination for study inclusion if readings exceed these limits. The PENN cardiologists and medical monitor are available for consultation when needed\n9. Negative pregnancy test and using adequate contraception if of childbearing potential.\n\nExclusion Criteria:\n\n1. Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission\n2. Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification\n3. Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine\n4. Pending incarceration or plans to leave the immediate area in the next 30 days\n5. Homicidal or otherwise behaviorally disturbed requiring immediate attention\n6. High risk for suicide as determined by answering 'yes' to questions 4 and\u002For 5 on C-SSRS\n7. Blood pressure \\\u003C90 mm Hg (systolic) or \\\u003C60 mm Hg (diastolic). If value out of normal range, the investigator and study Clinician will decide subject inclusion\u002Fexclusion on case-by-case basis\n8. Heart rate and\u002For pulse\\\u003C50 bpm at screening-sitting\n9. An Estimated Glomerular Filtration Rate eGFR\\\u003C70 mL\u002Fmin\u002F1.73m2\n10. A History of, or current Seizure disorder (excluding childhood febrile seizures)\n11. Inability to read and\u002For understand English. For example, unable to understand the informed consent as demonstrated by failing to answer 9\u002F10 questions correctly on the quiz\n12. 12\\. Pregnant or breastfeeding\n13. 13\\. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic\n14. ALT and\u002For AST \\>4X upper limit of normal\n15. A Child-Pugh score \\>7\n16. Currently receiving opioids for pain management\n17. In a treatment study where medication was administered in the last 30 days\n18. Currently using medications that are known to be strong or moderate inhibitors of CYP2D6 such as fluoxetine, paroxetine, mirabegron, bupropion, quinidine, terbinafine, cimetidine, cinacalcet, duloxetine, or fluvoxamine\n19. In a methadone maintenance or buprenorphine treatment program within the last 30 days",[64,65],"ADULT","OLDER_ADULT",[67,88],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":85},"Mountain Manor Treatment Center","NOT_YET_RECRUITING","Baltimore","Maryland","21229-3618","United States",[75,80,83],{"name":76,"role":77,"phone":78,"email":79},"Marc Fishman, MD","CONTACT","4102331400","Mfishman@marylandtreatment.org",{"name":81,"role":77,"phone":78,"email":82},"kevin Wenzel","kwenzel@marylandtreatment.org",{"name":76,"role":84},"PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},39.29038,-76.61219,{"facility":89,"status":7,"city":90,"state":91,"zip":92,"country":73,"contacts":93,"geoPoint":104},"University of Pennsylvania, Treatment Research Center","Philadelphia","Pennsylvania","19104",[94,98,102],{"name":95,"role":77,"phone":96,"email":97},"Kyle Kampman, MD","(215)222-3200","kampman@mail.med.upenn.edu",{"name":99,"role":77,"phone":100,"email":101},"Sabrina A Poole, PsyD","2157468802","spoole@pennmedicine.upenn.edu",{"name":103,"role":84},"Kyle M Kampman, MD",{"lat":105,"lon":106},39.95238,-75.16362,[108,111],{"name":103,"role":77,"phone":109,"email":110},"215-746-2764","Kampman@pennmedicine.upenn.edu",{"name":112,"role":77,"phone":113,"email":114},"Matthew R Taylor","215-746-0467","matthew.taylor@pennmedicine.upenn.edu",[],[],[],{"nct_id":4,"conditions":119,"biomarkers":121},[120],"Opioid Use Disorder",[],{"nct_id":4,"found":14,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is a placebo-controlled study where 150 participants will be randomly assigned to receive either lofexidine\u002Fpregabalin or lofexidine\u002Fplacebo pregabalin.","completed","Pregabalin Plus Lofexidine for Opioid Withdrawal","This study is testing if a combination of lofexidine and pregabalin can help people manage opioid withdrawal symptoms as outpatients. You could be eligible if you are at least 18 years old, have an opioid use disorder, and are interested in naltrexone (an opioid antagonist treatment). The study aims to see if this drug combination is safe and effective in reducing withdrawal symptoms, measured by your scores on the Subjective Opioid Withdrawal Scale (SOWS) over 10 days. The study is currently unclear on its recruitment status and plans to enroll 150 participants.","Your withdrawal symptoms will be measured for 10 days, through the completion of the study.",92,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]