[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"methadone\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:methadone":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100474553","phase-2-divided-or-single-exposure-dose-study-100474553",false,"NCT05459402","Divided or Single Exposure (DOSE) Study","Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment","Inclusion Criteria:\n\n* Aged 18 years of age or older\n* Currently receiving methadone for treatment of OUD for \\>90 days and have been consuming the same dose for \\>30 days\n* Have previously received a take-home dose of methadone as part of routine care\n* Willing to comply with study schedule\n* Report pain (specific definition blinded)\n* Have a cellular phone or be willing to carry phone provided by the study during one phase of the study\n\nExclusion Criteria:\n\n* Pregnant\n* Presence of acute medical problem that requires immediate and intense medical management\n* Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and\u002For adherence to study visits\n* Plans to leave methadone treatment during the study period\n* Maintained on a dose of methadone that would prevent effective splitting of doses\n* Currently receiving split doses of methadone\n* Currently receiving treatment for pain for which the split-dosing of methadone is judged by medical staff to be contraindicated or otherwise interfere with study conduct or integrity\n* Does not meet criteria for mild-severe disability (definition blinded)","ALL","18 Years","100 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.",[28,29,30],"Opioid Use Disorder","Chronic Pain","Methadone","RECRUITING","2026-01-30",{"date":34,"type":35},"2026-02-03","ACTUAL",{"date":37,"type":35},"2023-02-21",{"date":39,"type":21},"2028-06-01",{"name":41,"class":42},"University of Maryland, Baltimore","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100515003","phase-2-evaluating-tetrahydrocannabinol-as-an-adjunct-to-opioid-agonist-therapy-100515003","NCT05985850","Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy","Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy for Individuals Living With Opioid Use Disorder: A Phase II, Placebo-controlled, Blinded, Pilot Study to Assess Safety and Feasibility (THC-MMT)","THC-MMT","Inclusion Criteria:\n\n1. Individuals of at least 25 years of age or older;\n2. Diagnosed with OUD as per DSM-5 criteria;\n3. Initiated or re-initiated methadone-based OAT within the past 30 days prior to study entry;\n4. Cannabis-use experienced, defined as having used any amount of cannabis in the six months prior to the screening visit;\n5. Willing to only use study-provided cannabis as directed by study protocol, including abstention from non-study cannabis and cannabinoids;\n6. Agree to keep all study medication stored in a secure location and not to share\u002Fdistribute study medication to any other individual;\n7. If assigned female sex at birth:\n\n   1. Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and over 45 years of age); or (ii) documented surgical sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or\n   2. If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening;\n8. Ability to understand and comply with study protocol procedures and to provide written informed consent.\n\nInclusion criteria for Phase 2\n\nIn addition to meeting all eligibility criteria outlined in Phase 1, participants will be eligible for Phase 2 provided they meet ALL the following criteria at Week 12:\n\n1. Participants who have not experienced a study medication-related serious adverse event during Phase 1;\n2. Participants who have not been lost to follow-up during Phase 1.\n\nExclusion Criteria:\n\n1. Any disabling, severe, or unstable medical or psychiatric condition that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent, as assessed by medical and psychiatric history, physical examination, vital signs, and\u002For laboratory tests;\n2. Any severe or unstable co-morbid substance use disorder (e.g., delirium tremens, acute alcohol intoxication) that, in the opinion of the study physician, precludes safe participation in the study;\n3. Currently pregnant or breastfeeding, or planning to become pregnant;\n4. Known or suspected allergy or hypersensitivity to cannabinoids;\n5. History of respiratory disease, severe cardiovascular, cerebrovascular, renal or liver disease;\n6. Current or historic cannabis use disorder;\n7. Taking warfarin, clopidogrel, clobazam, theophylline, clozapine and olanzapine medications as they may interact with cannabinoids in a clinically significant manner if they cannot be switched to a different medication;\n8. Any personal or family history (first degree relative) of primary psychotic disorders (i.e., schizophrenia, schizoaffective disorder) as per DSM-5 criteria;\n9. Unable to abstain from driving any vehicle or operating machinery for at least 10 hours after taking the study medication. In cases where impairment persists beyond the initial 10-hour period, participants must continue to adhere to these restrictions until the impairment resolves;\n10. Actively participating in other interventional clinical trial(s);\n11. Incarcerated, pending legal action or other reasons that might prevent completion of the study.","25 Years",{"count":54,"type":21},24,[24],"This pilot study will evaluate the feasibility and safety of using 1:1 tetrahydrocannabinol (THC):Cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based Opioid Agonist Therapy (OAT) for individuals with opioid use disorder (OUD) in a community setting.",[28,30,58,59],"Cannabis","Fentanyl",[61,28,58,62,63,64,65,66],"addiction","Harm Reduction","Opioid","Pain","Quality of Life","Cannabidiol","2025-02-14",{"date":69,"type":35},"2025-02-17",{"date":71,"type":35},"2024-05-23",{"date":73,"type":21},"2027-03",{"name":75,"class":42},"BC Centre on Substance Use"]