[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581738":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Morphine","ACTIVE_COMPARATOR",null,[13],"Drug: Morphine p.o.",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Morphine p.o.","Morphine 50mg PO will be given on sleep study night.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"Placebo will be given on the sleep study night.",[15],[29],{"name":30,"affiliation":5,"role":31},"Danny J Eckert, PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Nicole Calianese","CONTACT","617-732-8977","ncalianese@mgb.org",[39],{"facility":5,"status":11,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Boston","Massachusetts","02115","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},[52,53],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},{"name":30,"role":31,"phone":11,"phoneExt":11,"email":11},{"type":31,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Danny J. Eckert","Principal Investigator","100581738","early-phase-1-impacts-of-opioids-on-respiratory-drive-during-sleep-100581738",false,"NCT06854211","Impacts of Opioids on Respiratory Drive During Sleep","Mechanisms of Opioid-induced Respiratory Depression (OIRD) During Sleep","OIRD","Inclusion Criteria:\n\n* Healthy controls: Apnea Hypopnea Index (AHI) \\\u003C 5 events\u002Fhr on in-laboratory PSG within 3 months of enrollment\n* OSA group: AHI \\> 10 events\u002Fhr on in-laboratory PSG within 3 months of enrollment; treated or untreated.\n\nExclusion Criteria:\n\n* Sleep disordered breathing or respiratory disorders (other than OSA in the OSA group), such as central sleep apnea (\\>50% of respiratory events scored as central), chronic hypoventilation\u002Fhypoxemia (awake SaO2 \\\u003C 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.\n* Other sleep disorders: periodic limb movements (periodic limb movement index \\> 20\u002Fhr), narcolepsy, or parasomnias.\n* Any unstable major medical condition.\n* Medications expected to stimulate or depress respiration (including other opioids taken at home, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).\n* History of allergy to lidocaine or oxymetazoline.\n* Contraindications for morphine, including:\n* allergy to morphine or opioids\n* chronic obstructive pulmonary disease, asthma, or other significant respiratory disorders\n* kidney or liver dysfunction, as this can affect the metabolism and excretion of morphine, leading to increased risk of toxicity.\n* women who are pregnant or breastfeeding will be excluded due to potential risks to the fetus or infant.\n* history of substance abuse, particularly opioid abuse, will be excluded to prevent potential misuse or relapse.\n* current use of central nervous system depressants.\n* individuals with gastrointestinal obstruction. Constipation is not an exclusion criterion because morphine is only administered for one night.\n* recent head injury, brain tumors, or other conditions leading to increased intracranial pressure.\n* unstable heart disease, particularly those with risk factors for or a history of heart rhythm disorders.\n* epilepsy or a history of seizures, as morphine can lower the seizure threshold.\n* severe psychiatric conditions, particularly those with a history of psychosis, as opioids can exacerbate these conditions.\n* medications that interact with morphine, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), Monoamine oxidase inhibitors (MAOIs), and the atypical antidepressants buproprion and trazodone.\n* untreated or unstable endocrine disorders like adrenal insufficiency or thyroid dysfunction.",true,"ALL","18 Years","65 Years",{"count":70,"type":71},26,"ESTIMATED","INTERVENTIONAL",[74],"EARLY_PHASE1","The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.",[77,78],"Opioids","Obstructive Sleep Apnea (OSA)","NOT_YET_RECRUITING","2026-01-28",{"date":82,"type":83},"2026-01-29","ACTUAL",{"date":85,"type":71},"2026-07-01",{"date":87,"type":71},"2027-01-31",{"name":5,"class":6},1]