[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"overdose-accidental\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:overdose-accidental":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100564801","phase-2-naltrexone-for-overdose-prevention-100564801",false,"NCT06633900","Naltrexone for Overdose Prevention","Extended-Release Naltrexone as Opioid Overdose Pre-Exposure Prophylaxis (PrEP) in People Using Stimulants Living With or At Risk of HIV","NOD","Inclusion Criteria:\n\n1. at-risk for HIV or living with HIV\n2. stimulant use disorder (by DSM-V) or positive urine drug test for cocaine, amphetamine, or methamphetamine in last 6 months AND report at least 10 days of stimulant use\u002Fmonth,\n3. able to provide informed consent,\n4. English-speaking,\n5. age 18 years old or greater.\n\nExclusion Criteria:\n\n1. prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by DSM-V),\n2. receipt of long-acting injectable naltrexone for other indications in past 30 days,\n3. planned surgery in next 6 months,\n4. moderate, severe or chronic liver disease (AST, ALT ≥ 5 times the upper limit of normal or symptoms of current liver disease),\n5. persons who are pregnant or breastfeeding,\n6. increased risk of bleeding (thrombocytopenia \\\u003C50 x 109\u002FL, coagulopathy, or therapeutic anticoagulation),\n7. known hypersensitivity to naltrexone or its diluents, or\n8. any other reason (e.g. comorbid medical conditions, adherence concerns, lack of interest in naltrexone, etc.) that judged by the study team's discretion, would impede the participant from successfully completing the trial.",true,"ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are:\n\nWhat are the challenges for implementing naltrexone as an overdose prevention strategy?\n\nAre injections of naltrexone effective for opioid overdose prevention among people who use stimulants?\n\nHow often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids?\n\nResearchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other.\n\nParticipants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. Usual care includes harm reduction supplies. Laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.",[29],"Overdose Accidental",[31,32,33,34,35,36],"stimulants","cocaine","methamphetamine","overdose prevention","naltrexone","fentanyl exposure","RECRUITING","2026-06-05",{"date":40,"type":41},"2026-06-09","ACTUAL",{"date":43,"type":41},"2025-04-10",{"date":45,"type":22},"2027-04-15",{"name":47,"class":48},"University of California, San Francisco","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100581780","families-left-behind-100581780","NCT06854757","Families Left Behind","Families Left Behind: Addressing Prolonged Grief and Substance Use Disorders Among People Bereaved by Drug Overdose Deaths","Inclusion Criteria:\n\n* people who lost a loved one to an unintentional drug overdose death within the past year\n* age 18 and older\n* fluently understand English or Spanish\n* have the capacity to give consent (e.g., excluding those with severe cognitive impairment, those in active psychosis, and those with developmental disabilities).\n\nExclusion Criteria:\n\n* people who need hospitalization for psychiatric symptoms or substance use disorders. (Note, people who use drugs but who do not require hospitalization will be included.)\n* people have active suicidal ideation\n* people who lost someone to a drug overdose death more than one year ago\n* people who lost someone to a drug overdose death that was suicidal in nature or of undetermined intent",{"count":58,"type":22},340,[60],"NA","The United States is facing unprecedented rates of drug overdose deaths, profoundly impacting millions of families who are left to navigate their grief. Those bereaved by overdose experience a unique form of grief characterized by feelings of guilt, shame, and blame, which can worsen their suffering and deter them from seeking help. Individuals coping with overdose loss often endure more severe health consequences compared to those grieving non-drug related deaths, including prolonged grief disorder, substance use disorders, PTSD, depression, and suicidal thoughts. Moreover, bereaved individuals, particularly those with a history of substance use, may engage in risky behaviors as a means of coping, further exacerbating the risk of overdose and mortality within this vulnerable population. Peer grief support interventions have emerged as a promising approach to assist those experiencing such losses. To combat these outcomes, we are collaborating with Peer Community Support Partners (PSCP) in a novel practice-research partnership to implement the RIVER peer grief support model. Though RIVER has shown success in community settings, it has yet to be rigorously evaluated. In a three-aim approach, this study aims to assess the effectiveness of the RIVER model while also enhancing and engaging grievers with support resources via medical examiner offices (MEOs), which routinely contact families during death investigations. This research represents a pivotal advancement in addressing the needs of the overlooked bereaved community, aligning with the NIH's Helping to End Addiction Long-term (HEAL) initiative to develop effective strategies against the opioid crisis. Together, community engagement and rigorous research efforts aim to enhance support for those affected by the tragedy of drug overdose.",[63,64,29,65],"Grief","Grief Disorder, Prolonged","Substance Use Disorders",[67,68,69,70],"overdose","grief","bereavement","prolonged grief disorder","2025-08-15",{"date":73,"type":41},"2025-08-21",{"date":75,"type":41},"2025-06-13",{"date":77,"type":22},"2030-10",{"name":79,"class":48},"RAND",4]