[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-dependence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-dependence":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,73,98,128,163,194,223,250,269,295],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100503007","early-phase-1-measuring-acute-drug-demand-in-humans-100503007",false,"NCT05829655","Measuring Acute Drug Demand in Humans","Inclusion Criteria:\n\n* Age between 18 and 65 years old\n* Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)\n* Lifetime substance use history criterion \\[blinded\\]\n* Medically cleared to take suvorexant and blinded study medications\n* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Seeking opioid use treatment\n* Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff\n* Known contraindications or allergies to suvorexant and\u002For the blinded study medications",true,"ALL","18 Years","65 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.",[27,28],"Opioid Use Disorder","Opioid Dependence","RECRUITING","2026-06-19",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2023-08-08",{"date":37,"type":21},"2028-01-01",{"name":39,"class":40},"University of Maryland, Baltimore","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100560197","phase-4-better-options-for-chronic-cancer-pain-100560197","NCT06574009","Better Options for Chronic Cancer Pain","Better Options for Chronic Cancer Pain: a SMART Study","Inclusion Criteria:\n\n* Veterans must have had a qualifying solid tumor (bladder, breast, colorectal, head and neck, liver, lung, pancreas, prostate, or urinary tract) without evidence of active disease for at least 6 months\n* Participants must be 6 months away from their last receipt of cytotoxic, radiation, or surgical cancer treatments but can be on hormonal or biologic therapies needed to sustain remission or cancer control.\n* Participants must report pain \\>=4 (on 0-10 NRS) on their last 3 recordings in the electronic medical record. Veterans should be on Long Term Opioid Therapy (LTOT) defined as:\n\n  * a qualifying opioid analgesic dispensed within the prior 30 days\n  * plus 150 days' supply of a qualifying opioid (fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone) in the 180 days before the most recent dispensing date with no between-fill gaps \\>40 days\n* There must be advance agreement from their existing opioid prescriber to resume opioid prescribing after study\n\nExclusion Criteria:\n\n* Veterans with total daily opioid doses \\>= 300 Morphine Milligram Equivalents (MME) will be excluded (higher doses require tapering prior to rotation to buprenorphine, which is something the investigators do not want to examine in this study)\n* Veterans with referrals or visits to a substance abuse clinic within the prior 2 years will be excluded to avoid including individuals requiring addiction expertise that is not available one the multidisciplinary pain teams\n* The investigators will also exclude Veterans with:\n\n  * current or past use of buprenorphine\n  * active alcohol use disorder or substance use\n  * risk factors for opioid overdose (e.g. active suicidality or history of self-directed violence)\n  * daily use of benzodiazepines\n  * receipt of opioids from non-VA providers in the prior 3 months\n  * or aberrant urine drug screen at baseline (cannabis is not exclusionary)\n* To ensure the relevance of our work to as many Veteran cancer survivors as possible, the investigators will not exclude subjects meeting DSM criteria for opioid use disorder if their only source of opioids is the VA","99 Years",{"count":51,"type":21},294,[53],"PHASE4","This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.",[56,57,28],"Chronic Pain","Cancer Survivor",[59,60,61],"survivorship","chronic pain","analgesics","2026-05-07",{"date":64,"type":33},"2026-05-11",{"date":66,"type":33},"2025-10-07",{"date":68,"type":21},"2029-12-31",{"name":70,"class":71},"VA Office of Research and Development","FED",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":41},"100337587","reducing-opioid-use-for-chronic-pain-patients-following-surgery-100337587","NCT03675386","Reducing Opioid Use for Chronic Pain Patients Following Surgery","Ontario Transitional Pain and Opioid Safety Program: Improving Pain and Opioid Practices for Complex Chronic Pain Patients Following Surgery","RECOUP","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Taking 10 -- 400 mg of preoperative oral morphine equivalents daily\n* Any type of surgical procedure, with the exception of those with palliative intent or organ transplantation\n* Able to read and understand English as posed on the questionnaire surveys prior to informed consent\n* Must be taking opioids for at least one month prior to their operation\n* Must have a personal email address for the set-up of the Manage My Pain (MMP) App or online multimedia tool\n\nExclusion Criteria:\n\n• Subjects who are undergoing palliative care or procedures, organ transplantation, or prescribed with Methadone\u002FBuprenorphine will be excluded from the trial",{"count":82,"type":21},210,[84],"NA","Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and severity of chronic post-surgical pain. The TPSP incorporates a variety of mechanisms and interventions to help patients manage pain and to wean off opioids. The approach consists of: pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile self- management tool to help patients manage chronic pain more effectively. With the TPSP team, the investigators hope to continually assist patients to achieve a balance between the benefits and potential harms of opioid use to promote long-term health and well-being.",[56,87,88,28],"Opioid Use","Postoperative Pain","2026-04-24",{"date":91,"type":33},"2026-04-30",{"date":93,"type":33},"2018-10-15",{"date":95,"type":21},"2026-12-31",{"name":97,"class":40},"University Health Network, Toronto",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":41},"100578256","phase-1-vk4-116-phase-i-study-with-food-effect-100578256","NCT06808932","VK4-116 Phase I Study With Food-Effect","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study With Food-Effect Cohort to Assess the Safety, Tolerability, and Pharmacokinetics of Oral (R) VK4-116 in Healthy Volunteers","Inclusion Criteria:\n\n1. Be a healthy male or female volunteer between 18 and 60 years of age, inclusive, at the time of consent.\n\n   • The masculine \u002F feminine gender is used without any discrimination and with the aim to lighten the text.\n2. Have a body mass index (BMI) within a range of 17.0 to 36.0 kg\u002Fm2 and a minimum weight of at least 50.0 kg at screening.\n3. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.\n4. Have no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.\n5. A female study participant must meet one of the following criteria:\n\n   * If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:\n\n     i. abstinence from heterosexual intercourse, ii. hormonal contraceptives (e.g., injectable\u002Fimplant\u002Finsertable hormonal birth control products, transdermal patch), iii. intrauterine device (with or without hormones). OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication.\n   * If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation\u002Focclusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (≥40 mIU\u002FmL).\n\n   A male study participant that engages in sexual activity must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.\n6. Be able and willing to comply with protocol requirements and the rules and regulations of the study site, and be likely to complete all the study treatments.\n\nExclusion Criteria:\n\n1. Have any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs or ECGs that contraindicate participation in the study. This includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.\n2. Use nicotine products via smoking\u002Fvaping in past 6 months.\n3. Have a sitting systolic blood pressure (BP) \\>140 mmHg, diastolic BP \\>90 mmHg and heart rate (HR) \\\u003C45 or \\>100 beats per minute (BPM) at screening and clinic intake.\n4. History of unstable angina; a history of myocardial infarction; or a history of a clinically significant cardiac arrhythmia,\n5. Has a QT interval corrected for heart rate using Fredericia formula \\>450 milliseconds in males or \\>470 milliseconds in females, or evidence of left bundle branch blocks (Note: right bundle branch block is acceptable), second or third degree AV block, or evidence of left ventricular hypertrophy on ECG\n6. Have a history of liver disease or current elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT), 2 × the upper limit of normal (ULN).\n7. Have a history of renal disease or current renal function test values as follows:\n\n   * blood urea nitrogen (BUN) \\>2 × ULN,\n   * creatinine (Cr) \\>1.5 mg\u002FdL.\n8. Have donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.\n9. Have donated plasma within 7 days prior to screening.\n10. Have hemoglobin value of \\\u003C13 g\u002FdL for men and \\\u003C12 g\u002FdL for women.\n11. Have undergone treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening.\n12. Have taken prescribed medications within 14 days of Day -1 or over-the-counter medications, dietary supplements, herbal products, or vitamins within 7 days or 5 half-lives (if known), whichever is longer, of Day -1.\n13. Have a positive urine drug test for alcohol, opioids (e.g., codeine, heroin, fentanyl, morphine, oxycodone, etc.), cocaine, amphetamine, methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), benzodiazepines, tetrahydrocannabinol (THC), barbiturates, propoxyphene, or phencyclidine\u002Fphenylcyclohexyl piperidine (PCP) at admission.\n14. Have a history of suicide attempts or current or recent evidence of suicidal ideation in the past 12 months based on the Columbia-Suicide Severity Rating Scale (C-SSRS).\n15. Have a positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).\n16. Have positive results for a coronavirus disease 2019 (COVID-19) test.\n17. Have a history of anaphylaxis and known allergy to any drug formulation.\n18. Have a history of consumption of any product containing grapefruit, pomelo, Seville oranges, or alcohol within 7 days before study drug dosing on Day 1.\n19. Have consumed any product containing caffeine or xanthine within 24 hours before study drug dosing on Day 1","60 Years",{"count":107,"type":21},48,[109],"PHASE1","This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study is designed to assess the safety, tolerability and pharmacokinetics of VK4-116 in healthy volunteers in fasted and fed state.",[28,112],"Opioid Use Disorder (OUD)",[114,115,116],"addiction","dopamine","dopamine receptor","NOT_YET_RECRUITING","2026-04-06",{"date":120,"type":33},"2026-04-09",{"date":122,"type":21},"2026-08-01",{"date":124,"type":21},"2027-08-30",{"name":126,"class":127},"National Institute on Drug Abuse (NIDA)","NIH",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":41},"100589085","phase-4-buprenorphine-as-a-post-operative-analgesic-in-opioid-naive-patients-after-ankle-fracture-surgery-100589085","NCT06949826","Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery","A Single-institution, Parallel, Double-blinded, Randomized Study Assessing the Safety and Efficacy of Transdermal Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery","BAFA","INCLUSION CRITERIA:\n\n* Patient is 18 years of age or older\n* Patient is undergoing single stage ORIF of an ankle fracture\n* Patient is English-speaking\n\nEXCLUSION CRITERIA:\n\n* Patient is under 18 years of age\n* Patient's ankle fracture is treated with external fixation\n* Patient has a concomitant osseous or visceral injury\n* Patient has a history of opioid use disorder or a current diagnosis of opioid use disorder\n* Patient has a history of alcohol use disorder or a current diagnosis of alcohol use disorder\n* Patient was taking opioid medication or narcotic drugs prior to their injury\n* Patient has a current active malignancy\n* Patient is taking a medication that carries a prohibitively high risk of drug-drug interaction with buprenorphine, hydrocodone, or oxycodone in the view of their treating physician or nurse anesthetist\n* Patient has an anaphylactic allergy to buprenorphine, hydrocodone, or oxycodone\n* Patient is not English-speaking\n* Patient is pregnant\n* Patient is unable to complete pain diary or communicate pain scores\n* Patient is incarcerated\n* Patient has a Gustilo-Anderson Type III open fracture",{"count":137,"type":21},100,[53],"Addictive full-agonist opioids, like oxycodone and hydrocodone, are often used to treat pain after surgery. However, these full-agonist opioids can be very addictive. After ankle fracture surgery, about 1 in 5 patients that did not take opioids before surgery become addicted to opioids after surgery. Buprenorphine is an opioid with unique properties that may offer a way to reduce the number of patients that become addicted to opioids after surgery. Buprenorphine has good analgesic (painkilling) effects. It is also thought to be less addictive and cause less of a high than full-agonist opioids, like oxycodone and hydrocodone. This project's goal is to determine if transdermal buprenorphine can safely and effectively control pain after ankle fracture surgery. This study will be a pilot study, which sets the stage for future studies that investigate whether buprenorphine can reduce the rate that patients become addicted to opioids after surgery. This study's multidisciplinary team will divide patients into two groups. Participants in one group will be treated with a 7-day transdermal buprenorphine patch (where the buprenorphine is slowly absorbed through the skin over 7 days). Participants in the other group will be treated with a placebo patch. A placebo has no drug in it, it just looks like the buprenorphine patch. Aside from the buprenorphine patch or placebo patch, both groups' pain management plans will be the same as if they were not in the study. Over the first week after surgery, the investigators will measure the amount of full-agonist opioids (for example, oxycodone or hydrocodone) that participants consume, participants' pain scores, the frequency of side effects related to opioids, and the number of calls and patient portal messages to the clinic for uncontrolled pain. The investigators will also assess whether participants are continuing to use opioids 3 months after surgery for pain related to their ankle fracture.",[141,142,27,28,143],"Pain, Postoperative","Ankle Fracture Surgery","Opioid Analgesia",[145,146,147,148,149,150,151,152,153,154],"Buprenorphine","Postoperative pain","Transdermal buprenorphine","Ankle fracture surgery","Ankle fracture","Opioid-naive patient","ORIF Ankle Fracture","Opioid use disorder","Opioid Addiction","Buprenorphine for postoperative pain","2026-03-30",{"date":118,"type":33},{"date":158,"type":33},"2025-04-21",{"date":160,"type":21},"2027-06",{"name":162,"class":40},"Jenna-Leigh Wilson",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":179,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":41},"100580466","the-moud-plus-pilot-counseling-and-peer-support-to-support-retention-for-medically-complex-patients-with-opioid-use-disorder-seen-in-primary-care-100580466","NCT06837662","The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care","Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The \"MOUD PLUS (MOUD+)\" Study","MOUD+","Inclusion Criteria:\n\n* Eligibility\u002FInclusion Criteria. For Aim 3, criteria we seek to recruit include:\n* Patient participants 18 years and older\n* Have an OUD-related diagnosis (e.g. Opioid Use Disorder in remission, Opioid Dependence, Opioid Abuse, Substance Use Disorder - opioids, etc.), or have used fentanyl or heroin over the past 30 days\n* Who meet at least one of the following criteria:\n\n  * Present to primary care at Central City Concern (CCC) within 8 weeks of starting or re-starting a treatment episode (defined as starting MOUD after not having received prescribed MOUD in an outpatient setting for OUD in the prior 30 days).\n  * Who present to primary care at CCC and are not seeking treatment with MOUD and have not engaged in counseling services (e.g. harm reduction counseling) in the prior 30 days\n  * Have been receiving MOUD in prior 30 days but had a return to use (used fentanyl or heroin) within the past 30 days\n* Medical complexity (e.g. self-reported or verified in patient's electronic health record)\n* Have access to phone and\u002For computer for follow-up activities\n* Desire to engage in counseling and\u002For peer services\n\nExclusion Criteria:\n\n* Patient participants who present for addiction treatment but are ineligible to receive on-going services at Central City (i.e. they have existing primary care at another location, or are currently receiving opioid use disorder treatment at another clinic, such as methadone clinic) may not participate in the study.\n* Patient participants who are not able to verbally consent may not participate in the study.\n* Patients who do not have addiction to opioids may not participate in the study.\n* Patients who participated in Aim 2 would not be eligible for Aim 3\n* Patients who lack stable phone access may not participate in the study.",{"count":172,"type":21},70,[84],"The goal of this pilot clinical trial is to learn if a community informed designed program of addiction counseling with coordinated community peer navigator for people with Opioid Use Disorder (OUD) and other medical conditions can improve engagement in primary care and retention on buprenorphine.\n\nThe main questions it aims to answer are:\n\n* Does the addition of a counseling and peer referral interventions in addition to usual primary care with low-threshold buprenorphine increase retention on medications for opioid use disorder?\n* Does the addition of counseling and peer referral intervention in addition to usual primary care with low-threshold buprenorphine increase engagement in primary care?\n\nResearchers will compare the MOUD \"Plus\" intervention compared to primary care treatment as usual low-threshold buprenorphine prescribing practice to see if MOUD \"Plus\" improves retention and engagement.\n\nParticipants will upon screening and enrollment:\n\n* Meet with prescribers who will determine dose of buprenorphine and assess other medical issues as per treatment as usual with visits every 2-4 weeks\n* Meet with the integrated addictions counselor to develop rapport and support around clinic engagement, brief counseling intervention, and coordination of care in support of their MOUD\n* Be referred to a community based peer who meets with participants outside the clinic for support and advocacy for patient directed recovery goals\n* Meet with the research coordinator at 2, 3, and 6 months to complete follow-up surveys about their care and experiences",[28,176,177,178],"Substance Abuse Disorders","Complex Medical Patients","Primary Care Patients With Chronic Conditions",[180,181,182,183,184],"opioid use disorder","medications for opioid use disorder","recovery capital","collaborative care model","addiction treatment","2026-02-23",{"date":187,"type":33},"2026-02-25",{"date":189,"type":33},"2025-03-24",{"date":191,"type":21},"2026-12-01",{"name":193,"class":40},"Oregon Health and Science University",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":41},"100484222","phase-2-standardized-natural-psilocybin-assisted-psychotherapy-for-tapering-of-opioid-medication-100484222","NCT05585229","Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication","Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication in Patients With Chronic Pain: an Open-label Feasibility Study","Inclusion Criteria:\n\n1. Must be 19 - 75 years of age.\n2. Have a diagnosed noncancer chronic pain condition including but not limited to neuropathic pain, fibromyalgia, chronic headaches\u002Fmigraines, back pain, musculoskeletal pain.\n3. Currently on a stable dose of opioid therapy on short-acting, long-acting, or combination of opioid medication types, for a minimum duration of 90 consecutive days.\n4. History of at least one unsuccessful attempt to taper or discontinue long-term opioid therapy, and has expressed current interest in making another attempt to reduce or discontinue.\n5. Able to swallow capsules\u002Ftablets.\n6. If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study.\n\nExclusion Criteria:\n\n1. Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, greater than first degree AV block, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, chronic bradycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition.\n2. Asthma\n3. Have moderate to severe hepatic impairment.\n4. Chronic pain is due to cancer.\n5. Women who are pregnant, who intend to become pregnant during the study, or who are currently breastfeeding.\n6. Have a history of stroke or Transient Ischemic Attack (TIA).\n7. Meet DSM-5 criteria for severe alcohol or drug use disorders (other than Opioid use Disorder).\n8. Nicotine dependence that would prevent the participant from remaining nicotine free for the duration of dosing sessions (i.e., 6-8 hours).\n9. Have Epilepsy.\n10. Clinically significant sleep disorders such as sleep apnoea not on appropriate treatment.\n11. Have Insulin-dependent diabetes.\n12. Participants who are or have been taking mood stabilizers (e.g. lithium), SSRIs\u002FSNRIs (e.g. citalopram, venlafaxine, vortioxetine, duloxetine), herbal remedies with serotonin activity (e.g. 5-HTP, St. John's Wort), dopamine agonists (e.g. bupropion), tricyclic antidepressants (e.g. amitriptyline), antipsychotics (e.g. haloperidol), amphetamines (e.g. amphetamine\u002Fdextroamphetamine salts, methylphenidate, dextroamphetamine, lisdexamfetamine), monoamine oxidase inhibitors (e.g. isocarboxazid, phenelzine, selegiline, tranylcypromine), alcohol or aldehyde dehydrogenase inhibitors (e.g. disulfiram), and UDG modulators (i.e. UGT modulators such as phenytoin, regorafenib, eltrombopag) during the study or in the preceding 8 weeks.\n13. Hallucinogenic or psychedelic drug use within 12 months (i.e. any use of mescaline, 2C-B, psilocybin, LSD, 5-MeO-DMT, ibogaine ayahuasca, MDA, MDMA, ketamine or any related molecules).\n14. Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder.\n15. Have a first degree relative with schizophrenia, Bipolar I or Bipolar II Disorder.\n16. Meet DSM-5 criteria for diagnosis of antisocial or borderline personality disorders.\n17. Participants with a history of a developmental disorder.\n18. Participants diagnosed with serious comorbidities that may or may not influence mental health in the opinion of the qualified investigator.","19 Years","75 Years",{"count":204,"type":21},10,[206],"PHASE2","This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering\u002Fdiscontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psilocybin-assisted therapy sessions. The study will evaluate the incidence and severity of adverse events during and after treatment, the number of participants who drop out of the study for intervention-related reasons, and the self-reported benefits and harms of the intervention.",[28,56],[210,211,212,56,213,27],"Opioid Tapering","Psilocybin","Psychotherapy","Hallucinogens","2025-11-26",{"date":216,"type":33},"2025-12-04",{"date":218,"type":33},"2025-10-27",{"date":220,"type":21},"2026-08-31",{"name":222,"class":40},"University of British Columbia",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":41},"100566142","fmri-and-opioid-abstinence-100566142","NCT06651333","fMRI and Opioid Abstinence","Functional Connectivity Mechanisms of Opioid Abstinence","Inclusion Criteria:\n\n* recent initiation of methadone or buprenorphine at a clinic or program within the past year (i.e., period of time during which treatment drop-out and risk for relapse is highest);\n* eligibility for MRI scanning;\n* ability to commit to study visits.\n\nExclusion Criteria:\n\n* current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5;\n* current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and SOWS assessment;\n* severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore \\\u003C30 (i.e., severe impairment)\n* past or present history of intellectual disability, developmental disorder, or neurological disease;\n* head trauma with loss of consciousness \\>30 min;\n* organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.","50 Years",{"count":232,"type":21},240,"OBSERVATIONAL","This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.",[236,28,237,87,238],"Drug Use Disorder","Opioid-Related Disorders","Opioid Abuse",[240],"Relapse","2025-10-16",{"date":243,"type":33},"2025-10-20",{"date":245,"type":33},"2024-12-12",{"date":247,"type":21},"2029-11",{"name":249,"class":40},"Yale University",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":4},"100526067","assessing-the-acceptability-feasibility-effectiveness-and-cost-effectiveness-of-ladb-100526067","NCT06129916","Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB","Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of Long-acting Depot Buprenorphine (LADB) for the Treatment of Opioid Dependence in Low- and Middle-income Countries (LMIC): a Multicentre International Study","Inclusion Criteria:\n\n* Are 18 years old or older.\n* Are verified (by certified clinician) opioid dependents according to the International Classification of Diseases 11th Revision.\n* Are not pregnant (verified by screening).\n* Are eligible to receive OAMT at a participating site.\n* Consent to attend the clinic and adhere to clinical protocols\n* Have the capacity to consent to participating in research.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Have a history or presence of an allergic or adverse response (including rash or anaphylaxis) to BUP or the Atrigel® delivery system (a registered trademark of Tolmar Therapeutics Inc.) if Sublocade is chosen.\n* Have any contraindication to BUP or methadone.\n* Show signs of clinically significant medical conditions which would compromise compliance with the protocol and\u002For client safety in line with clinical guidelines for the administration of injectable BUP for OAMT.\n* Are currently taking oral or depot naltrexone therapy or are enrolled in any form of naltrexone therapy within 30 or 90 days prior to study screening, respectively.\n* Are in thepost partum period (defined as 6 weeks) or confirmed as pregnant.\n* Have an inability or unwillingness to provide informed consent or abide by the requirements of the study.",{"count":258,"type":21},760,"The goal of the proposed study is to generate evidence on the acceptability, feasibility, effectiveness, and cost-effectiveness of introducing long-acting depot buprenorphine (LADB) as an additional option for the treatment of opioid dependence in low- and middle-income countries (LMIC) among people who inject drugs (PWID) with opioid dependence. The study results will be used to inform global and local policies and guidelines to introduce LADB as a treatment option and to advocate for access to a sustainable supply of LADB in LMIC.",[28],"2025-10-01",{"date":66,"type":33},{"date":264,"type":21},"2025-11-01",{"date":266,"type":21},"2027-06-30",{"name":268,"class":40},"PATH",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":41},"100424754","phase-4-young-houston-emergency-opioid-engagement-system-100424754","NCT04811014","Young Houston Emergency Opioid Engagement System","Houston Emergency Engagement System for Youths and Adolescents","YHEROES","Inclusion Criteria:\n\n* In otherwise good health based on physician assessment and medical history\n* Drug screen positive for opioids\n* Patients express a willingness to stop opioid use\n* Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence\n* Patients must be able to speak English\n* Be agreeable to and capable of signing the informed consent and assent (parent or guardian must consent, minor must assent)\n\nExclusion Criteria:\n\n* Non-English-speaking patients\n* Have a known sensitivity to buprenorphine or naloxone\n* Be physiologically dependent on alcohol, benzodiazepines, or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.\n* Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)\n* Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk\n* Be a nursing or pregnant female","13 Years","17 Years",{"count":280,"type":21},250,[53],"The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.",[284,28,285,87,286],"Opioid-use Disorder","Opioid Overdose","Substance Use Disorders","2025-09-26",{"date":261,"type":33},{"date":290,"type":33},"2021-04-19",{"date":292,"type":21},"2030-08-31",{"name":294,"class":40},"The University of Texas Health Science Center, Houston",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":15,"sex":302,"minAge":17,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":299,"conditions":307,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":41},"100486966","phase-1-a-clinical-trial-to-assess-pharmacokinetic-profiles-safety-and-tolerability-of-ivl3004-and-ivl4002-in-healthy-male-subjects-100486966","NCT05620940","A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.","A PHASE 1, OPEN-LABEL, EXPLORATORY, FIXED-SEQUENCE, PHARMACOKINETIC SINGLE ASCENDING DOSE STUDY OF IVL3004 VERSUS VIVITROL® (NALTREXONE) LONG-ACTING INJECTABLE (LAI) AND IVL4002 IN HEALTHY SUBJECTS","Inclusion Criteria:\n\n1. Healthy adult male, ≥18 and ≤55 years of age, non-smokers or occasional smokers (defined as smoking less than 10 cigarettes or nicotine equivalent per week, and willing to abstain from smoking during confinement at the clinical site).\n2. BMI ≥18.0 and ≤32.0 kg\u002Fm2 and body weight ≥55.0 kg.\n3. Healthy as defined by:\n\n   1. The absence of clinically significant illness, infection, or medical\u002Fsurgical procedure within 4 weeks prior to dosing or planned inpatient surgery (including dental surgery) or hospitalization during the study period.\n   2. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological (including autoimmune), psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.\n4. Subjects who are not vasectomized for at least 3 months prior to dosing, and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from dosing and for 90 days after dosing:\n\n   a. Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used for at least 4 weeks or intrauterine device placed for at least 4 weeks prior to dosing.\n5. Subjects who have had a vasectomy must be willing to use a condom until study exit.\n6. Subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.\n7. Subjects must be willing not to donate sperm for 90 days after dosing.\n8. Willing to undergo SC abdominal injection or IM ventral gluteal injection to allow for investigational drug administration.\n9. Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any protocol- specific study procedures.\n\nExclusion Criteria:\n\n1. Any clinically significant abnormal finding at physical examination at screening or Day -1.\n2. Clinically significant abnormal laboratory test results at screening or Day -1, or positive serology test results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus at screening.\n3. Is prone to skin rashes, irritation, or has a skin condition such as recurrent eczema that is likely to impact the injection site area or demonstrates any abnormal skin tissue in the proposed injection area, as determined by the Investigator.\n4. Any history of malignancy or neoplastic disease.\n5. History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug, or to any excipient present in the formulations.\n6. ALT, AST, or total bilirubin \\>1.5x upper limit of normal (ULN) at screening or Day -1.\n7. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2 as calculated by the 2021 Chronic Kidney Disease-Epidemiology (CKD-EPI) equation at screening or Day -1.\n8. Clinically significant ECG abnormalities (QTc \\>450 ms or PR interval \\>220 ms) or vital sign abnormalities (systolic blood pressure \\\u003C90 or \\>140 mmHg, diastolic blood pressure \\\u003C40 or \\>90 mmHg, or heart rate \\\u003C40 or \\>100 bpm) at screening or Day -1.\n9. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 units of alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of spirit 40%), or positive alcohol test at screening or Day -1.\n10. History of drug abuse within 1 year prior to screening or positive test for drugs of abuse (e.g., phencyclidine, opiates, benzodiazepines, barbiturates, amphetamines, methamphetamines, cocaine, and tetrahydrocannabinol) at screening or Day -1.\n11. Presence of any underlying physical or psychological (e.g., depression) medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. Mild depression and anxiety that has been resolved at least 6 months prior to screening is accepted.\n12. Use of medications for the timeframes specified below, with the exception of hormonal contraceptives and medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety:\n\n    1. Depot injection or implant within 3 months prior to dosing;\n    2. Strong CYP inhibitors or inducers within 30 days prior to dosing;\n    3. Prescription medications within 14 days prior to dosing;\n    4. Any vaccine, including COVID-19 vaccine, within 7 days prior to dosing;\n    5. OTC medications (including topical and nasal formulations with active pharmaceutical ingredients) within 7 days prior to dosing, except for occasional use of acetaminophen\u002Fparacetamol (up to 2 g\u002Fday);\n    6. Natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to dosing;\n    7. Anesthetic agents within 24 hours prior to dosing.\n    8. Anticoagulant medications from 15 days prior to dosing to 6 weeks post- dose.\n13. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.\n14. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to dosing.\n15. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.","MALE","55 Years",{"count":305,"type":21},40,[109],[28,308,309],"Alcohol Dependence","Multiple Sclerosis","2025-09-09",{"date":312,"type":33},"2025-09-15",{"date":314,"type":33},"2024-09-11",{"date":316,"type":21},"2025-12-30",{"name":318,"class":319},"Inventage Lab., Inc.","INDUSTRY"]