[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528213":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":54,"studyPopulation":50,"armGroups":55,"interventions":67,"overallOfficials":77,"centralContacts":81,"locations":90,"responsibleParty":108,"collaborators":111,"id":115,"slug":50,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":50,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":50,"enrollmentInfo":123,"targetDuration":50,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":50,"overallStatus":92,"whyStopped":50,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":43},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Enrollment feasibility\u002Facceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages","To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period.","6 weeks following enrollment",{"measure":14,"description":15,"timeFrame":12},"Protocol adherence feasibility\u002Facceptability benchmarks of participants completing modules and sleep diaries each week - Engagement","Completing at least one module per week, submitting a minimum of four sleep diaries per week, and implementing stimulus control and sleep restriction on at least 90% of nights.",{"measure":17,"description":18,"timeFrame":12},"mHealth App Usability Questionnaire","Validated measure of mobile app usability with 3 sections: Ease of use\u002Fsatisfaction, system information arrangement, and usefulness",[20,24,27,30,34,37,40],{"measure":21,"description":22,"timeFrame":23},"Pittsburgh Sleep Quality Index","Validated measure of difficulty falling and staying asleep and subsequent daytime function","At enrollment and 6 weeks following enrollment",{"measure":25,"description":26,"timeFrame":23},"Structured Clinical Interview for Sleep Disorders - Revised Edition","Assessment for sleep disorders based on the DSM-5",{"measure":28,"description":29,"timeFrame":23},"Insomnia Severity Index","Global sleep quality; the most common self-reported sleep measure",{"measure":31,"description":32,"timeFrame":33},"Daily Sleep Diary - Sleep Onset Latency","Subjective sleep onset latency (time to fall asleep)","Through study completion of 6 weeks",{"measure":35,"description":36,"timeFrame":33},"Daily Sleep Diary - Wake-time After Sleep","Subjective time awake after sleep onset",{"measure":38,"description":39,"timeFrame":33},"Daily Sleep Diary - Total Sleep Time","Subjective total sleep time",{"measure":41,"description":42,"timeFrame":33},"Daily Sleep Diary - Sleep Efficiency","Subjective sleep efficiency",[44],{"measure":45,"description":46,"timeFrame":33},"MOUD and drug use","Self-reported checklist",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":50,"timePerspective":50,"maskingInfo":52},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":53,"maskingDescription":50,"whoMasked":50},"NONE","This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment with medications for opioid use disorder. Additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. Participants (N=40, 20 per group) will be randomized to download the mHealth app to their smartphones and complete the intervention within 6 weeks. The control group will receive a simplified version of the app with sleep hygiene instructions. Both groups will complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. At the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility\u002Facceptability measures and measures of insomnia severity.",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"mHealth application","EXPERIMENTAL","Study participants, while being stabilized on buprenorphine, will download and engage with the developed mHealth application, completing daily electronic sleep diaries for the next 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity.",[61],"Device: mHealth application and sleep health education",{"label":63,"type":58,"description":64,"interventionNames":65},"Control Group","Participants in the control group will receive a simplified version of the app with sleep hygiene (SH) instructions and will be required to complete daily electronic sleep diaries for the next 6 weeks. The SH condition will utilize the same application and entail the same daily and weekly logs, but with the didactic material replaced by detailed education about SH strategies. Each week, participants will be asked to complete a brief assessment of their experiences from the previous week and their current insomnia severity.",[66],"Device: Simplified mHealth application and sleep health education",[68,73],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":50},"DEVICE","mHealth application and sleep health education","Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity",[57],{"type":69,"name":74,"description":75,"armGroupLabels":76,"otherNames":50},"Simplified mHealth application and sleep health education","Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will receive a simplified version of the app with sleep hygiene instructions and will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity.",[63],[78],{"name":79,"affiliation":5,"role":80},"Allison K Wilkerson, Ph.D.","PRINCIPAL_INVESTIGATOR",[82,87],{"name":83,"role":84,"phone":85,"phoneExt":50,"email":86},"Allison K Willkerson, Ph.D.","CONTACT","843-792-4636","wilkersa@musc.edu",{"name":88,"role":84,"phone":50,"phoneExt":50,"email":89},"Jacelyn Lane","lanejac@musc.edu",[91],{"facility":5,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"RECRUITING","Charleston","South Carolina","29464","United States","US",{"type":99,"coordinates":100},"Point",[101,102],-79.93275,32.77632,{"lat":102,"lon":101},[105],{"name":106,"role":84,"phone":107,"phoneExt":50,"email":86},"Allison Wilkerson, PhD","8437924636",{"type":80,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Allison Wilkerson","Associate Professor",[112],{"name":113,"class":114},"National Institute on Drug Abuse (NIDA)","NIH","100528213",false,"NCT06157840","Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD","Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder","Inclusion Criteria:\n\n* No experience of withdrawal symptoms in past 2 weeks\n* Being stabilized on buprenorphine\n\n  1. Initiated buprenorphine in past 3 months\n  2. Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)\n* Currently experiencing clinically significant sleep disturbance (PSQI \\> 5)\n* Able to read and understand English\n* Owns an Android or iOS smartphone\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Current psychotic symptoms\n* Current active suicidal ideation\n* Severe visual impairment\n* Current use of benzodiazepines\n* Current severe SUD other than OUD (i.e., \\> 5 criteria met for any other SUD type per DSM-5)\n* Peripartum women","ALL","18 Years",{"count":124,"type":125},40,"ESTIMATED","INTERVENTIONAL",[128],"NA","This study is to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.",[131,132],"Opioid Use Disorder","Poor Quality Sleep","2026-05-11",{"date":135,"type":136},"2026-05-12","ACTUAL",{"date":138,"type":136},"2025-08-25",{"date":140,"type":125},"2026-09-30",{"name":5,"class":6},1]