[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654675":3},{"organization":4,"outcomesModule":7,"designInfo":103,"detailedDescription":108,"studyPopulation":108,"armGroups":116,"interventions":128,"overallOfficials":141,"centralContacts":149,"locations":155,"responsibleParty":171,"collaborators":108,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":175,"sex":181,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":108,"studyType":187,"phases":188,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":202,"whyStopped":108,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"University of Calgary","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":78},[9,13,16,19,23,27],{"measure":10,"description":11,"timeFrame":12},"Feasibility: Participant Recruitment Rate","Measured by assessing the number of participants recruited into the study (28 anticipated) throughout study duration (24 months estimated).","From first participant in until study closure (estimated 24 months).",{"measure":14,"description":15,"timeFrame":12},"Feasibility: Participant Retention Percentage","Measuring the number of participants who complete the study compared to the total number of study participants, displayed as a percentage (%).",{"measure":17,"description":18,"timeFrame":12},"Tolerability: Participant Drop-Out Rates","Measured by comparing frequency of participant drop-outs in treatment versus control groups.",{"measure":20,"description":21,"timeFrame":22},"Safety: Adverse Event Frequency","Measured by comparing the frequency of adverse events in the treatment versus control groups.","Participants will have the opportunity to report adverse events daily during the study treatment phase (days 0-21).",{"measure":24,"description":25,"timeFrame":26},"Safety: MADRS-S Depression","Measured using the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S) which scores depression from 0-54, with higher scores indicating worse depression.","The MADRS-S will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).",{"measure":28,"description":29,"timeFrame":30},"Safety: C-SSRS Suicidality","Measured using the Columbia Suicide Severity Rating Scale (C-SSRS), which uses Yes\u002FNo answers to categorize into No, Low, Moderate, or High risk.","The C-SSRS will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).",[32,36,40,44,48,52,56,59,63,66,70,74],{"measure":33,"description":34,"timeFrame":35},"Sleep (Objective): Actigraphy Data","Participants will wear actigraphy watches continuously during the study treatment phase in order to measure objective sleep data.","Measured continuously during the study treatment phase (days 0-21).",{"measure":37,"description":38,"timeFrame":39},"Sleep (Subjective): PSQI","The Pittsburgh Sleep Quality Index (PSQI) will be used as a subjective measure of sleep. Scores can range from 0-21, with higher scores indicating worse sleep.","The PSQI will be administered at pre-screening and day 21.",{"measure":41,"description":42,"timeFrame":43},"Sleep (Subjective): LSEQ","The Leeds Sleep Evaluation Questionnaire (LSEQ) is a subjective measure of sleep which uses a 100mm visual analog scale, with lower scores being indicative of worse sleep.","Participants will take the LSEQ on days 0, 7, 14, and 21 throughout the study treatment phase (days 0-21).",{"measure":45,"description":46,"timeFrame":47},"Sleep (Subjective): Daily Diaries CSD","Participants will complete daily diaries each morning via REDCap, which will include questions regarding their prior night's sleep from the Consensus Sleep Diary (CSD).","Daily diaries will be completed daily during the study treatment phase (days 0-21).",{"measure":49,"description":50,"timeFrame":51},"Cannabis Use (Objective): Plasma THC and Metabolites","Blood draws will be performed in order to measure plasma THC and metabolite levels as an objective measure of cannabis use.","Blood draws will occur on days 0 and 21 during the study treatment phase (days 0-21).",{"measure":53,"description":54,"timeFrame":55},"Cannabis Use (Subjective): EC-TLFB","The Enhanced Cannabis Timeline Followback (EC-TLFB) will be administered during study visits in order to subjectively assess participant cannabis use.","The EC-TLFB will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).",{"measure":57,"description":58,"timeFrame":47},"Cannabis Use (Subjective): Daily Diaries","Participants will complete daily diaries each morning via REDCap, which will include questions regarding their cannabis use from the day prior.",{"measure":60,"description":61,"timeFrame":62},"Cannabis Use (Subjective): DFAQ-CU","The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQ-CU) measures multiple aspects of cannabis consumption in participants, and will be used as part of our subjective cannabis use measurements.","The DFAQ-CU will be administered on days 0 and 21 during the study treatment phase (days 0-21).",{"measure":64,"description":65,"timeFrame":47},"Cannabis Withdrawal: Daily Diaries Modified MWC","The Marijuana Withdrawal Checklist (MWC) asks participants to score their severity of 22 marijuana withdrawal symptoms. On a scale of 0-66, higher scores indicate worse marijuana withdrawal symptoms. We have adapted the MWC to ask participants about their prior day's symptoms, and included it as part of the REDCap daily diaries.",{"measure":67,"description":68,"timeFrame":69},"Cognition: Divided Attention","Divided attention cognitive tasks assess participants' ability to focus on one task versus multiple tasks, with less difference between the them indicating better cognitive outcomes.","Divided attention cognitive tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).",{"measure":71,"description":72,"timeFrame":73},"Cognition: Working Memory","Working memory will be assessed via N-back and word memory tasks, with better scores being indicative of better cognitive function.","N-back and word memory tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).",{"measure":75,"description":76,"timeFrame":77},"Cognition: Planning via Tower of London","The Tower of London task assesses participant planning ability, with higher scores indicative of better planning and cognition.","Tower of London will be administered on days 0 and 21 during the study treatment phase (days 0-21).",[79,82,85,88,91,94,97,99],{"measure":80,"description":21,"timeFrame":81},"Follow-Up Outcome (Safety): Adverse Event Frequency","Participants will have the opportunity to report adverse events daily during the study follow-up phase (days 22-35).",{"measure":83,"description":25,"timeFrame":84},"Follow-Up Outcome (Safety): Depression","The MADRS-S will be administered on day 35 during the study follow-up phase (days 22-35).",{"measure":86,"description":29,"timeFrame":87},"Follow-Up Outcome (Safety): Suicidality","The C-SSRS will be administered on day 35 during the study follow-up phase (days 22-35).",{"measure":89,"description":42,"timeFrame":90},"Follow-Up Outcome (Sleep): LSEQ","Participants will take the LSEQ on day 35 during the study follow-up phase (days 22-35).",{"measure":92,"description":46,"timeFrame":93},"Follow-Up Outcome (Sleep): Daily Diaries CSD","Daily diaries will be completed daily during the study follow-up phase (days 22-35).",{"measure":95,"description":54,"timeFrame":96},"Follow-Up Outcome (Cannabis Use): EC-TLFB","The EC-TLFB will be administered on day 35 during the study follow-up phase (days 22-35).",{"measure":98,"description":58,"timeFrame":93},"Follow-Up Outcome (Cannabis Use): Daily Diaries",{"measure":100,"description":101,"timeFrame":102},"Follow-Up Outcome (Withdrawal): Daily Diaries Modified MWC","The Marijuana Withdrawal Checklist (MWC) asks participants to score their severity of 22 marijuana withdrawal symptoms. On a scale of 0-66, higher scores indicate worse marijuana withdrawal symptoms. We have adapted the MWC to ask participants about their prior day's symptoms, and included it in the REDCap daily diaries.","The modified MWC will be completed daily during the study follow-up phase (days 22-35).",{"allocation":104,"interventionModel":105,"interventionModelDescription":106,"primaryPurpose":107,"observationalModel":108,"timePerspective":108,"maskingInfo":109},"RANDOMIZED","PARALLEL","Participants will be randomized into either the treatment group (10mg Lemborexant) or the control group (placebo) at a 1:1 ratio.","TREATMENT",null,{"masking":110,"maskingDescription":108,"whoMasked":111},"QUADRUPLE",[112,113,114,115],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[117,123],{"label":118,"type":119,"description":108,"interventionNames":120},"Lemborexant 10mg","EXPERIMENTAL",[121,122],"Drug: Lemborexant 10mg","Behavioral: Brief Behavioural Intervention",{"label":124,"type":125,"description":108,"interventionNames":126},"Placebo","PLACEBO_COMPARATOR",[127,122],"Drug: Placebo",[129,133,136],{"type":130,"name":118,"description":131,"armGroupLabels":132,"otherNames":108},"DRUG","21 days of 10mg Lemborexant, taken nightly.",[118],{"type":130,"name":124,"description":134,"armGroupLabels":135,"otherNames":108},"21 days of visually-matched placebo, taken nightly.",[124],{"type":137,"name":138,"description":139,"armGroupLabels":140,"otherNames":108},"BEHAVIORAL","Brief Behavioural Intervention","Participants will receive a brief behavioural intervention at the in-person study visits aimed at helping participants identify ways to reduce their cannabis use.",[118,124],[142,145,147],{"name":143,"affiliation":5,"role":144},"David N Crockford, MD","PRINCIPAL_INVESTIGATOR",{"name":146,"affiliation":5,"role":144},"Leah M Mayo, PhD",{"name":148,"affiliation":5,"role":144},"Stephanie L Borgland, PhD",[150],{"name":151,"role":152,"phone":153,"phoneExt":108,"email":154},"Sophie J Bell, BSc","CONTACT","587-893-0257","sophie.bell@ucalgary.ca",[156],{"facility":157,"status":108,"city":158,"state":159,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":168,"contacts":169},"University of Calgary (Foothills Campus)","Calgary","Alberta","T2N4N1","Canada","CA",{"type":164,"coordinates":165},"Point",[166,167],-114.08529,51.05011,{"lat":167,"lon":166},[170],{"name":151,"role":152,"phone":153,"phoneExt":108,"email":154},{"type":172,"investigatorFullName":108,"investigatorTitle":108,"investigatorAffiliation":108,"oldNameTitle":108,"oldOrganization":108},"SPONSOR","100654675","phase-1-lemborexant-for-cannabis-use-disorder-100654675",false,"NCT07802990","Lemborexant for Cannabis Use Disorder","Lemborexant as a Potential Pharmacotherapy for the Treatment of Cannabis Use Disorder (CUD)","LemboCAN","Inclusion Criteria:\n\n* Moderate to severe Cannabis Use Disorder.\n* Ability to read\u002Fwrite in English.\n\nExclusion Criteria:\n\n* Known allergies or hypersensitivities to Lemborexant.\n* Use of any Orexin-Antagonist in the past 3 months.\n* Current or recent (within the past 12 weeks) participation in a clinical trial involving medication administration.\n* Narcolepsy, Complex sleep behaviors, sleep apnea, restless leg syndrome, and Periodic Limb Movement Disorder.\n* Currently undergoing treatment for CUD.\n* Any hospitalization or emergency department visit related to cannabis use.\n* Moderate to severe hepatic impairment.\n* Past or ongoing moderate to severe psychiatric disorders.\n* Active suicidal ideation or serious attempt within the past 3 years.\n* Epilepsy or history of seizures.\n* Blood pressure over 160\u002F95mmHg at the screening session.\n* Current pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study.","ALL","18 Years","65 Years",{"count":185,"type":186},28,"ESTIMATED","INTERVENTIONAL",[189,190],"PHASE1","PHASE2","The goal of this clinical trial is to investigate the use of Lemborexant as a treatment for moderate to severe Cannabis Use Disorder (CUD). The main questions it aims to answer are:\n\n1. Is Lemborexant safe, feasible, and tolerable to use in the CUD population?\n2. Will the use of Lemborexant for CUD help to decrease cannabis use, improve sleep, decrease cannabis withdrawal symptoms, and improve cognition?\n\nResearchers will compare 10mg Lemborexant to placebo.\n\nParticipants will:\n\n* Take 10mg Lemborexant (or placebo) nightly for 21 nights (treatment phase).\n* Wear an actigraphy watch continuously for the treatment phase.\n* Complete a pre-screen survey, attend an in-person screening session, 4 in-person lab visits (weekly from days 0-21), and a virtual follow-up visit 2 weeks after the treatment phase.\n* Complete a short daily survey for 35 days total.",[193],"Cannabis Use Disorder",[193,195,196,197,198,199,200,201],"Addiction","Sleep","Lemborexant","Actigraphy","Clinical trial","Cannabis","Marijuana","NOT_YET_RECRUITING","2026-09-17",{"date":205,"type":206},"2026-09-22","ACTUAL",{"date":208,"type":186},"2026-11",{"date":210,"type":186},"2028-11",{"name":5,"class":6},1]