{"id":"buprenorphine-sl","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Sweating"},{"rate":null,"effect":"Dizziness"}]},"_chembl":null,"_dailymed":{"setId":"77d3c308-58b8-2ab0-e053-2991aa0a4918","title":"BUPRENORPHINE HCL SL (BUPRENORPHINE HCL) TABLET [H.J. HARKINS COMPANY, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Buprenorphine binds with high affinity to mu-opioid receptors in the central nervous system but produces only partial agonist effects, creating a ceiling effect that limits euphoria and overdose risk compared to full opioid agonists. This partial agonism simultaneously suppresses withdrawal symptoms and reduces illicit opioid use by decreasing cravings. The sublingual formulation allows for rapid absorption and is commonly combined with naloxone to deter intravenous misuse.","oneSentence":"Buprenorphine is a partial mu-opioid receptor agonist that reduces cravings and withdrawal symptoms in opioid use disorder.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:23:18.369Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid use disorder (maintenance treatment)"},{"name":"Opioid dependence"}]},"trialDetails":[{"nctId":"NCT03911466","phase":"","title":"Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study","status":"COMPLETED","sponsor":"T. John Winhusen, PhD","startDate":"2020-07-21","conditions":"Opioid-Related Disorders, Drug Addiction, Pregnancy Related","enrollment":97},{"nctId":"NCT03911739","phase":"","title":"Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study","status":"COMPLETED","sponsor":"T. John Winhusen, PhD","startDate":"2021-06-14","conditions":"Opioid-Related Disorders, Drug Addiction, Pregnancy Related","enrollment":71},{"nctId":"NCT06854029","phase":"PHASE4","title":"NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings","status":"NOT_YET_RECRUITING","sponsor":"Duke University","startDate":"2026-06","conditions":"HIV Infections, Opioid Use Disorder, Incarceration; Lens","enrollment":300},{"nctId":"NCT06306443","phase":"PHASE3","title":"Buprenorphine for Individuals in Jail","status":"RECRUITING","sponsor":"Friends Research Institute, Inc.","startDate":"2025-07-01","conditions":"Opioid Use Disorder","enrollment":240},{"nctId":"NCT04375033","phase":"PHASE4","title":"A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2020-11-03","conditions":"Opioid Use Disorder","enrollment":952},{"nctId":"NCT06023459","phase":"PHASE3","title":"Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yih-Ing Hser","startDate":"2024-10-14","conditions":"Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders","enrollment":144},{"nctId":"NCT04464980","phase":"PHASE2","title":"Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"NYU Langone Health","startDate":"2021-06-08","conditions":"Opioid Use Disorder (OUD)","enrollment":1516},{"nctId":"NCT04345718","phase":"PHASE2, PHASE3","title":"EXHIT ENTRE Comparative Effectiveness Trial","status":"COMPLETED","sponsor":"Gavin Bart","startDate":"2021-08-09","conditions":"Substance Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe","enrollment":344},{"nctId":"NCT05339256","phase":"PHASE2","title":"Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual","status":"NOT_YET_RECRUITING","sponsor":"New York State Psychiatric Institute","startDate":"2026-02-01","conditions":"Opioid Use Disorder","enrollment":50},{"nctId":"NCT04948307","phase":"NA","title":"OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder","status":"COMPLETED","sponsor":"Orexo AB","startDate":"2021-06-30","conditions":"Opioid-use Disorder","enrollment":437},{"nctId":"NCT03918850","phase":"PHASE3","title":"Medication Treatment for Opioid Use Disorder in Expectant Mothers","status":"COMPLETED","sponsor":"T. John Winhusen, PhD","startDate":"2020-07-21","conditions":"Opioid-Related Disorders, Drug Addiction, Pregnancy Related","enrollment":140},{"nctId":"NCT04893525","phase":"PHASE2, PHASE3","title":"Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments","status":"RECRUITING","sponsor":"University of British Columbia","startDate":"2021-07-23","conditions":"Opioid-use Disorder","enrollment":658},{"nctId":"NCT06494904","phase":"PHASE3","title":"Standard Versus High Dose ED-Initiated Buprenorphine Induction","status":"RECRUITING","sponsor":"Yale University","startDate":"2024-12-06","conditions":"Opioid Use Disorder","enrollment":360},{"nctId":"NCT04225598","phase":"PHASE2","title":"Emergency Department-Initiated Buprenorphine Validation Network Trial","status":"COMPLETED","sponsor":"Yale University","startDate":"2020-07-08","conditions":"Opioid-use Disorder","enrollment":2000},{"nctId":"NCT04976855","phase":"PHASE1","title":"Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2022-08-17","conditions":"Healthy Volunteer, Opioid-use Disorder","enrollment":64},{"nctId":"NCT04234191","phase":"PHASE2","title":"Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder","status":"RECRUITING","sponsor":"University of British Columbia","startDate":"2021-08-18","conditions":"Opioid Use Disorder","enrollment":50},{"nctId":"NCT04283500","phase":"PHASE4","title":"Buprenorphine Loading in the Emergency Department","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2020-11-01","conditions":"Opioid-use Disorder","enrollment":15},{"nctId":"NCT03852628","phase":"PHASE2","title":"Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD","status":"TERMINATED","sponsor":"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","startDate":"2019-05-20","conditions":"Post Traumatic Stress Disorder, Alcohol Abuse","enrollment":69},{"nctId":"NCT05594121","phase":"PHASE4","title":"Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder","status":"UNKNOWN","sponsor":"Royal Victoria Hospital, Canada","startDate":"2022-12","conditions":"Moderate to Severe Opioid Use Disorder","enrollment":90},{"nctId":"NCT03744663","phase":"PHASE2","title":"Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films","status":"WITHDRAWN","sponsor":"Wake Forest University Health Sciences","startDate":"2022-06","conditions":"Opioid Use","enrollment":""},{"nctId":"NCT03492099","phase":"PHASE2","title":"Assessing the Safety of Buprenorphine in People With Sickle Cell Disease","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2018-08-01","conditions":"Sickle Cell Disease","enrollment":47},{"nctId":"NCT02672111","phase":"PHASE3","title":"Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder","status":"COMPLETED","sponsor":"Braeburn Pharmaceuticals","startDate":"2015-11","conditions":"Opioid Use Disorder","enrollment":228},{"nctId":"NCT03544112","phase":"","title":"Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2018-06-11","conditions":"Opioid-use Disorder","enrollment":390},{"nctId":"NCT02651584","phase":"PHASE3","title":"Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence","status":"COMPLETED","sponsor":"Braeburn Pharmaceuticals","startDate":"2015-12","conditions":"Opioid Use Disorders","enrollment":428},{"nctId":"NCT03715634","phase":"PHASE1","title":"Study of a Novel Subcutaneous Depot Formulation of Buprenorphine","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2017-09-20","conditions":"Opioid-use Disorder","enrollment":12},{"nctId":"NCT02180659","phase":"PHASE3","title":"A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants","status":"COMPLETED","sponsor":"Titan Pharmaceuticals","startDate":"2014-07","conditions":"Opioid Dependence","enrollment":177},{"nctId":"NCT00768482","phase":"PHASE3","title":"A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence","status":"TERMINATED","sponsor":"Titan Pharmaceuticals","startDate":"2008-09","conditions":"Opioid Dependence","enrollment":9},{"nctId":"NCT01114308","phase":"PHASE3","title":"A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction","status":"COMPLETED","sponsor":"Titan Pharmaceuticals","startDate":"2010-04","conditions":"Opioid Dependency","enrollment":287},{"nctId":"NCT02357901","phase":"PHASE3","title":"Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2015-01-28","conditions":"Opioid Dependence, Opioid Related Disorders","enrollment":665},{"nctId":"NCT01188421","phase":"PHASE1, PHASE2","title":"Medications Development for Drug Abuse Disorders","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2010-10","conditions":"Opioid Related Disorders, Opioid Dependence, Opioid Addiction","enrollment":106},{"nctId":"NCT03002961","phase":"PHASE1","title":"Single Ascending Dose Study of RBP-6000","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2012-07","conditions":"Opioid Use Disorder","enrollment":48},{"nctId":"NCT00710385","phase":"PHASE3","title":"Abuse Liability of Suboxone Versus Subutex","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2007-09","conditions":"Opioid-related Disorders","enrollment":19},{"nctId":"NCT02477267","phase":"PHASE1","title":"Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers","status":"COMPLETED","sponsor":"INSYS Therapeutics Inc","startDate":"2015-06","conditions":"Opiate Dependence","enrollment":47},{"nctId":"NCT00271219","phase":"PHASE3","title":"RCT Comparing Methadone and Buprenorphine in Pregnant Women","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2005-07","conditions":"Opioid Related Disorders, Pregnancy, Opioid Dependence","enrollment":175},{"nctId":"NCT01298297","phase":"PHASE4","title":"Efficacy of Buprenorphine for Treatment of Acute Pain","status":"COMPLETED","sponsor":"Tehran University of Medical Sciences","startDate":"2010-02","conditions":"Acute Pain","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Buprenorphine SL","genericName":"Buprenorphine SL","companyName":"New York State Psychiatric Institute","companyId":"new-york-state-psychiatric-institute","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Buprenorphine SL is a small molecule that acts as a mu opioid receptor agonist, classified as an agonist. It is used to treat opioid-related disorders, including drug addiction, and has been studied in clinical trials for conditions such as opioid-related disorders and substance abuse.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}