[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06316830":3,"trial-entities:NCT06316830":106,"trial-summary:NCT06316830":109},{"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":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":50,"maximum_age":17,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":68,"locations":71,"central_contacts":90,"overall_officials":95,"references":96,"see_also_links":105},"NCT06316830","STUDY00000075","Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose","Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder","RECRUITING","2027-11-01","2025-10","2025-10-23","2025-01-06","Rhode Island Hospital","OTHER",true,"The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).\n\nThe main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).",null,[19],"Opioid Use Disorder",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE2","PHASE3",{"count":27,"type":28},250,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Buprenorphine","Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.",[35,36],"High Maintenance Daily Dose (24mg)","Standard Maintenance Daily Dose (16mg)",[38],{"measure":39,"description":40,"timeFrame":41},"Treatment Engagement","The primary outcome is the percentage of participants retained in buprenorphine treatment. Participants will be classified as retained in buprenorphine treatment at six months post- randomization if (1) the study site data indicate that they remained engaged in treatment or (2) the PDMP suggest that they continued treatment elsewhere and have not had a gap of more than 27 days in medication on-hand based on fill dates and days' supply.","six months post-randomization",[43,46],{"measure":44,"description":45,"timeFrame":41},"Control of Opioid Cravings","Measured using patient reported outcomes via the Opioid Craving Scale, a reliable, validated scale for people with opioid use disorder. The scale consists of three questions related to opioid cravings rated on a scale of 1-10 with 1 being not at all and 10 being extremely. A higher score denotes increased opioid cravings.",{"measure":47,"description":48,"timeFrame":41},"Treatment response based on use of non-prescribed opioids","Non-prescribed fentanyl and other opioid use will be assessed via urine drug screens including fentanyl (UDS) and self-report. UDS will be assessed monthly for six months after study enrollment. Self-reported will be assessed at 1, 3, and 6 months via a Time Line Followback (TLFB) assessing ongoing non-prescribed opioid\u002Ffentanyl over the preceding two weeks. Based on UDS and self-reported data, participants will be classified as treatment responders if they have (1) no evidence (negative UDS and negative self-report) of non-prescribed opioid use at ≥1 assessment in months 1 to 3 AND (2) no evidence of non-prescribed opioid use at ≥2 assessments in months 4 to 6.","ALL","18 Years",false,{"inclusion":53,"exclusion":59,"raw_text":67},[54,55,56,57,58],"English-speaking","Age 18 years-old or older","Identified by the treating physician as having moderate to severe opioid use disorder (OUD)","Initiating or continuing buprenorphine for treatment of opioid use disorder","History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)",[60,61,62,63,64,65,66],"Previous enrollment in the trial","Incarcerated or in police custody\\*","Pregnant","Live outside of Rhode Island (RI)","Unable to provide informed consent","Allergy to Buprenorphine","Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \\*Participants that become incarcerated\u002For in police custody during the study will be withdrawn.","Inclusion Criteria:\n\n* English-speaking\n* Age 18 years-old or older\n* Identified by the treating physician as having moderate to severe opioid use disorder (OUD)\n* Initiating or continuing buprenorphine for treatment of opioid use disorder\n* History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)\n\nExclusion Criteria:\n\n* Previous enrollment in the trial\n* Incarcerated or in police custody\\*\n* Pregnant\n* Live outside of Rhode Island (RI)\n* Unable to provide informed consent\n* Allergy to Buprenorphine\n* Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \\*Participants that become incarcerated\u002For in police custody during the study will be withdrawn.",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"Brown University","Providence","Rhode Island","02912","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Jackie Goldman","CONTACT","401-808-6950","jacqueline_goldman1@brown.edu",{"name":85,"role":86},"Francesca Beaudoin","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},41.82399,-71.41283,[91,92],{"name":80,"role":81,"phone":82,"email":83},{"name":93,"role":81,"email":94},"Rachel Wightman, MD","rachel_wightman@brown.edu",[],[97,101],{"pmid":98,"type":99,"citation":100},"37721749","BACKGROUND","Chambers LC, Hallowell BD, Zullo AR, Paiva TJ, Berk J, Gaither R, Hampson AJ, Beaudoin FL, Wightman RS. Buprenorphine Dose and Time to Discontinuation Among Patients With Opioid Use Disorder in the Era of Fentanyl. JAMA Netw Open. 2023 Sep 5;6(9):e2334540. doi: 10.1001\u002Fjamanetworkopen.2023.34540.",{"pmid":102,"type":103,"citation":104},"39521460","DERIVED","Armeni K, Chambers LC, Peachey A, Berk J, Langdon KJ, Peterson L, Beaudoin FL, Wightman RS. Randomised clinical trial of a 16 mg vs 24 mg maintenance daily dose of buprenorphine to increase retention in treatment among people with an opioid use disorder in Rhode Island: study protocol paper. BMJ Open. 2024 Nov 9;14(11):e085888. doi: 10.1136\u002Fbmjopen-2024-085888.",[],{"nct_id":4,"conditions":107,"biomarkers":108},[19],[],{"nct_id":4,"found":15,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study comparing two different doses of buprenorphine. Participants will be randomly assigned to receive either a 16 mg or 24 mg daily dose.","completed","Buprenorphine Dosing for Opioid Use Disorder","This study is looking at whether a higher daily dose of buprenorphine (24 mg) is more effective than the standard dose (16 mg) for people with opioid use disorder (OUD) who have used fentanyl. Buprenorphine is a highly effective treatment for OUD. The study wants to see if the higher dose helps people stay in treatment longer, reduces their use of non-prescribed opioids, decreases cravings, and lowers the risk of overdose. You may be able to join if you are 18 or older, speak English, have moderate to severe OUD, are starting or continuing buprenorphine, and have a history of fentanyl use. The study aims to enroll 250 participants, but its current recruitment status is unclear.","Treatment engagement will be measured at six months post-randomization.",116,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]