[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06726200":3,"trial-entities:NCT06726200":109,"trial-summary:NCT06726200":112},{"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":40,"secondary_outcomes":48,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":80,"locations":83,"central_contacts":98,"overall_officials":106,"references":107,"see_also_links":108},"NCT06726200","AAAV2503","A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use","A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids","RECRUITING","2029-01-15","2026-05","2026-06-02","2026-02-25","Rachel R. Luba","OTHER",false,"The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and\u002For other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are:\n\nAre there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine?\n\nAre there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine?\n\nInvestigators also seek to understand and explore:\n\nHow factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes.\n\nHow blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes.\n\nHow factors like craving and opioid withdrawal symptoms influence treatment outcomes.\n\nParticipants will:\n\nComplete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine.\n\nProvide blood and urine samples while on the inpatient unit and at follow up.\n\nComplete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.",null,[19],"Opioid Use Disorder",[],"INTERVENTIONAL","TREATMENT",[24],"EARLY_PHASE1",{"count":26,"type":27},60,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Buprenorphine + naloxone (Suboxone)","Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines\u002Fstandard of care",[34],"Sublingual Buprenorphine\u002FNaloxone",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Buprenorphine Injection","Participants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving\u002Ftolerating a single 4\u002F1 mg sublingual buprenorphine\u002Fnaloxone dose",[39],"Injectable Buprenorphine",[41,45],{"measure":42,"description":43,"timeFrame":44},"Percentage of Days Abstinent from Opioids","Abstinence from Opioids (% days abstinent; continuous; longitudinal) during each week of the 4 week follow up period measured via the timeline follow back.","4 week follow up period",{"measure":46,"description":47,"timeFrame":44},"Sustained Relapse","Sustained relapse during the 4 week follow up period (binary), defined as 5 consecutive days of illicit opioid use reported on the timeline follow back at any point during the 4 week follow up period.",[49,53,56],{"measure":50,"description":51,"timeFrame":52},"Time to Peak Clinical Opiate Withdrawal Scale (COWS) score","The time to peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (time-to-event\u002Fsurvival). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms.","During the inpatient induction period (approximately 1 overnight stay)",{"measure":54,"description":55,"timeFrame":52},"Peak Clinical Opiate Withdrawal Scale (COWS) score","The peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (continuous). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms.",{"measure":57,"description":58,"timeFrame":52},"Dropout during induction","Dropout during the induction period (binary)","ALL","18 Years","65 Years",{"inclusion":63,"exclusion":69,"raw_text":79},[64,65,66,67,68],"Aged 18 to 65","Voluntarily seeking treatment for opioid use disorder (OUD)","Consistent use of fentanyl or other high potency synthetic opioids","Meets DSM-5 criteria for OUD with at least moderate severity","Able to provide written informed consent in English and willing to comply with study procedures",[70,71,72,73,74,75,76,77,78],"Meets DSM-5 criteria for another substance use disorder as the primary diagnosis","Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)","Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)","Buprenorphine or methadone treatment in the past 30 days","Known allergy, hypersensitivity or intolerance to buprenorphine","Pregnancy, lactation, or unwillingness to use adequate contraceptive methods","Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification","Liver function tests \\> 2x the upper limit of normal","Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days","Inclusion Criteria:\n\n* Aged 18 to 65\n* Voluntarily seeking treatment for opioid use disorder (OUD)\n* Consistent use of fentanyl or other high potency synthetic opioids\n* Meets DSM-5 criteria for OUD with at least moderate severity\n* Able to provide written informed consent in English and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Meets DSM-5 criteria for another substance use disorder as the primary diagnosis\n* Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)\n* Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)\n* Buprenorphine or methadone treatment in the past 30 days\n* Known allergy, hypersensitivity or intolerance to buprenorphine\n* Pregnancy, lactation, or unwillingness to use adequate contraceptive methods\n* Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification\n* Liver function tests \\> 2x the upper limit of normal\n* Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":8,"city":86,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"Substance Treatment and Research Service","New York","10019","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Administrative assistant","CONTACT","646-774-8189","RRL2117@cumc.columbia.edu",{"lat":96,"lon":97},40.71427,-74.00597,[99,102],{"name":100,"role":92,"phone":93,"email":101},"Rachel Luba, PhD","RRL2117@CUMC.Columbia.edu",{"name":103,"role":92,"phone":104,"email":105},"John Mariani, MD","212-923-3031","jm2330@cumc.columbia.edu",[],[],[],{"nct_id":4,"conditions":110,"biomarkers":111},[19],[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study comparing two different buprenorphine treatments. It plans to enroll 60 participants.","completed","Comparing Buprenorphine Formulations for Opioid Use Disorder","This study is comparing two forms of buprenorphine for treating opioid use disorder (OUD), especially for people who use fentanyl or other strong synthetic opioids. Researchers want to see if there are differences in how often people use drugs and if they have a relapse when using either buprenorphine + naloxone (Suboxone), which is taken under the tongue, or a buprenorphine injection. You might be able to join if you are 18-65 years old, are seeking OUD treatment, consistently use fentanyl or similar opioids, and meet specific diagnostic criteria. The study aims to enroll 60 participants. The current recruitment status is unclear.","Participants will be followed for 4 weeks to measure days abstinent from opioids and sustained relapse.",102,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]