{"protocolSection":{"identificationModule":{"nctId":"NCT00465972","orgStudyIdInfo":{"id":"8899"},"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"The Treatment of Insomnia in Patients With HIV Disease","officialTitle":"A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia."},"statusModule":{"statusVerifiedDate":"2013-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-03"},"primaryCompletionDateStruct":{"date":"2010-08","type":"ACTUAL"},"completionDateStruct":{"date":"2010-08","type":"ACTUAL"},"studyFirstSubmitDate":"2007-04-25","studyFirstSubmitQcDate":"2007-04-25","studyFirstPostDateStruct":{"date":"2007-04-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-12-12","resultsFirstSubmitQcDate":"2013-07-26","resultsFirstPostDateStruct":{"date":"2013-07-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-07-26","lastUpdatePostDateStruct":{"date":"2013-07-30","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.","detailedDescription":"Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population.\n\nComparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study."},"conditionsModule":{"conditions":["HIV Infections","Insomnia"],"keywords":["HIV","Insomnia","Cytokines","Adherence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":44,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo","interventionNames":["Drug: Placebo"]},{"label":"2","type":"ACTIVE_COMPARATOR","description":"Doxepin","interventionNames":["Drug: Doxepin"]},{"label":"3","type":"ACTIVE_COMPARATOR","description":"Temazepam","interventionNames":["Drug: Temazepam"]}],"interventions":[{"type":"DRUG","name":"Doxepin","description":"Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length","armGroupLabels":["2"]},{"type":"DRUG","name":"Temazepam","description":"Temazepam capsule 15 mg po nightly x duration of study","armGroupLabels":["3"]},{"type":"DRUG","name":"Placebo","description":"Placebo capsule nightly for duration of study","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Response: Change in Insomnia Severity Rating Scale at 3 Months.","description":"Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.","timeFrame":"Baseline and 3 months"}],"secondaryOutcomes":[{"measure":"Change in Piper Fatigue Scale at 3 Months","description":"A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.","timeFrame":"Baseline and 3 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Insomnia\n* HIV Seropositive\n* Stable HIV Disease\n\nExclusion Criteria:\n\n* Other psychiatric illnesses\n* Unstable HIV disease","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"69 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Andrew D Krystal, MD","affiliation":"Duke University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","zip":"27710","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]},"referencesModule":{"references":[{"pmid":"15784792","type":"BACKGROUND","citation":"Reid S, Dwyer J. Insomnia in HIV infection: a systematic review of prevalence, correlates, and management. Psychosom Med. 2005 Mar-Apr;67(2):260-9. doi: 10.1097/01.psy.0000151771.46127.df."},{"pmid":"22131611","type":"DERIVED","citation":"Low Y, Preud'homme X, Goforth HW, Omonuwa T, Krystal AD. The association of fatigue with depression and insomnia in HIV-seropositive patients: a pilot study. Sleep. 2011 Dec 1;34(12):1723-6. doi: 10.5665/sleep.1446."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"We initially planned to have 3 arms: placebo, temazepam, and doxepin. However, based on the rate of recruitment, we limited the study to 2 arms: placebo and temazepam.\n\nScreening was carried out which included medical, and psychiatric, and sleep assessments.","recruitmentDetails":"Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center","groups":[{"id":"FG000","title":"Placebo","description":"One sugar pill taken orally at bedtime for duration of the participant's involvement."},{"id":"FG001","title":"Temazepam","description":"One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"23"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"1 sugar pill taken nightly at bedtime."},{"id":"BG001","title":"Temazepam","description":"1 15 mg pill taken nightly at bedtime."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"41"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.46","spread":"5.1"},{"groupId":"BG001","value":"47.8","spread":"7.9"},{"groupId":"BG002","value":"48.1","spread":"6.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"18"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"23"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"38"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Insomnia Severity Index","description":"Measures the severity of insomnia on 7 items, with a rating of 0 (low severity) to 4 (high severity). Total range for the index is 0-28; with 28 being the most severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17.7","spread":"4.9"},{"groupId":"BG001","value":"16.6","spread":"5.1"},{"groupId":"BG002","value":"17.1","spread":"5.0"}]}]}]},{"title":"Piper Fatigue Scale","description":"A 22 item survey measuring level of fatigue. Subjects answer each item on a scale of 1 - 10, with 1 being low fatigue, and 10 being severe fatigue. Total range of overall score is 22-220, with 220 being severe fatigue.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"138","spread":"42"},{"groupId":"BG001","value":"114","spread":"48"},{"groupId":"BG002","value":"116","spread":"45"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Response: Change in Insomnia Severity Rating Scale at 3 Months.","description":"Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.","populationDescription":"This is the LOCF population","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 3 months","groups":[{"id":"OG000","title":"Placebo","description":"1 sugar pill taken orally at bedtime."},{"id":"OG001","title":"Temazepam","description":"1 15 mg pill of temazepam taken orally at bedtime."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"6.1"},{"groupId":"OG001","value":"-4.01","spread":"5.3"}]}]}]},{"type":"SECONDARY","title":"Change in Piper Fatigue Scale at 3 Months","description":"A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 3 months","groups":[{"id":"OG000","title":"Placebo","description":"1 sugar taken nightly at bedtime."},{"id":"OG001","title":"Temazepam","description":"1 15 mg pill taken nightly at bedtime."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12","spread":"6.1"},{"groupId":"OG001","value":"17","spread":"5.3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Placebo","description":"1 sugar pill taken nightly at bedtime.","seriousNumAffected":0,"seriousNumAtRisk":18,"otherNumAffected":2,"otherNumAtRisk":18},{"id":"EG001","title":"Temazepam","description":"1 15 mg pill taken orally, nightly, at bedtime.","seriousNumAffected":0,"seriousNumAtRisk":23,"otherNumAffected":4,"otherNumAtRisk":23}],"otherEvents":[{"term":"dry mouth","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":18},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":23}]},{"term":"sedation","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":18},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":23}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Andrew Krystal, MD, MS, Professor of Psychiatry and Behavioral Sciences","organization":"Duke University School of Medicine","email":"andrew.krystal@duke.edu","phone":"919-681-8742"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D015658","term":"HIV Infections"},{"id":"D007319","term":"Sleep Initiation and Maintenance Disorders"}],"ancestors":[{"id":"D000086982","term":"Blood-Borne Infections"},{"id":"D003141","term":"Communicable Diseases"},{"id":"D007239","term":"Infections"},{"id":"D015229","term":"Sexually Transmitted Diseases, Viral"},{"id":"D012749","term":"Sexually Transmitted Diseases"},{"id":"D016180","term":"Lentivirus Infections"},{"id":"D012192","term":"Retroviridae Infections"},{"id":"D012327","term":"RNA Virus Infections"},{"id":"D014777","term":"Virus Diseases"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D007153","term":"Immunologic Deficiency Syndromes"},{"id":"D007154","term":"Immune System Diseases"},{"id":"D020919","term":"Sleep Disorders, Intrinsic"},{"id":"D020920","term":"Dyssomnias"},{"id":"D012893","term":"Sleep Wake Disorders"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D004316","term":"Doxepin"},{"id":"D013693","term":"Temazepam"}],"ancestors":[{"id":"D010082","term":"Oxepins"},{"id":"D004988","term":"Ethers, Cyclic"},{"id":"D004987","term":"Ethers"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D003990","term":"Dibenzoxepins"},{"id":"D006575","term":"Heterocyclic Compounds, 3-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D001570","term":"Benzodiazepinones"},{"id":"D001569","term":"Benzodiazepines"},{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"}]}},"hasResults":true}