Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 8:04 AM
Study NCT ID:
NCT06444256
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total sleep duration as assessed by the actigraphy watch', 'timeFrame': 'Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11'}, {'measure': 'Change in wake after sleep onset measured via actigraphy watch', 'timeFrame': 'Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11'}, {'measure': 'Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI)', 'timeFrame': 'Day 5 and Day 12', 'description': "This is a 7 item questionnaire and is rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity."}, {'measure': 'Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)', 'timeFrame': 'Day 5 and Day 12', 'description': 'This is a 4 item questionnaire and each is scored from 1-5 for a score range of 4-20, higher number indicating worse outcome'}, {'measure': 'Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)', 'timeFrame': 'Day 5 and Day 12', 'description': 'This is an 8 item questionnaire and each is scored from 1-5 for a total score range of 8-40, higher number indicating worse outcome'}, {'measure': 'Change in self-reported stress as assessed by the Visual Analog Scale (VAS)', 'timeFrame': 'Day 5 and Day 12', 'description': 'This is measured from 0=no stress, 10=extreme stress'}, {'measure': 'Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS)', 'timeFrame': 'Day 5 and Day 12', 'description': 'The DASS 21 is a 21 item self report questionnaire. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week), higher score indicating a worse outcome'}, {'measure': 'Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ)', 'timeFrame': 'Day 5 and Day 12', 'description': 'This is a 10 item questionnaire, each is scored from 0 (strongly disagree) to 6 (strongly agree) for a total score range of 0-60, higher score indicating worse outcome'}], 'secondaryOutcomes': [{'measure': 'Change in resting state alpha power as assessed by EEG', 'timeFrame': 'Day 5 and Day 12'}, {'measure': 'Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task', 'timeFrame': 'Day 5 and Day 12', 'description': 'Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken'}, {'measure': 'Change in stress as indicated by the change in heart rate during the cold-pressor task', 'timeFrame': 'Day 5 and Day 12', 'description': 'Participants will submerge their hands in a bucket of ice water for upto 2 minutes and heart rate will be measured'}, {'measure': 'Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes', 'timeFrame': 'Day 5 and Day 12', 'description': 'Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured'}, {'measure': 'Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes', 'timeFrame': 'Day 5 and Day 12', 'description': 'Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured'}, {'measure': 'Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task', 'timeFrame': 'Day 5 and Day 12', 'description': 'The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.'}, {'measure': 'Change in intensity of demand as assessed by the Drug Purchasing Task', 'timeFrame': 'Day 5 and Day 12', 'description': 'Demand is the maximum quantity of Methamphetamine or Cocaine consumed if the drug was free measured in grams or dollar amount'}, {'measure': 'Length of stay (LOS)', 'timeFrame': 'at time of discharge (up to 30 days form baseline)'}, {'measure': 'Percentage of participants who complete the 30 day treatment', 'timeFrame': 'at time of discharge (up to 30 days form baseline)'}, {'measure': 'Change in side effects as assessed by the side effects questionnaire', 'timeFrame': 'Day 5 , Day 12', 'description': 'This 31-item questionnaire will be administered to assess side effects and adverse events in the SUVO group only'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychostimulants', 'substance use', 'methamphetamine', 'cocaine'], 'conditions': ['Stimulant Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)\n* Be fluent in English and able to understand the consent form\n\nExclusion Criteria:\n\n* Have an opioid use disorder of any severity\n* Have a greater than moderate substance use disorder on any other substance\n* Undergoing medication-assisted treatment for withdrawal of any substance\n* Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)\n* Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)\n* Are pregnant or breast feeding\n* BMI \\> 30 (women only)\n* Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe\n* Have history of seizure disorder\n* Have a head injury with loss of consciousness in the last 5 years'}, 'identificationModule': {'nctId': 'NCT06444256', 'briefTitle': 'Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study', 'orgStudyIdInfo': {'id': 'HSC-MS-24-0330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SUVO', 'interventionNames': ['Drug: SUVO', 'Drug: TAU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU', 'interventionNames': ['Drug: TAU']}], 'interventions': [{'name': 'SUVO', 'type': 'DRUG', 'description': 'Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11', 'armGroupLabels': ['SUVO']}, {'name': 'TAU', 'type': 'DRUG', 'description': 'Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.', 'armGroupLabels': ['SUVO', 'TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Webber, PhD', 'role': 'CONTACT', 'email': 'Heather.E.Webber@uth.tmc.edu', 'phone': '713-486-2723'}, {'name': 'Jessica Vincent', 'role': 'CONTACT', 'email': 'Jessica.N.Vincent@uth.tmc.edu', 'phone': '713-486-2645'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Heather Webber, PhD', 'role': 'CONTACT', 'email': 'Heather.E.Webber@uth.tmc.edu', 'phone': '713-486-2723'}, {'name': 'Jessica Vincent', 'role': 'CONTACT', 'email': 'Jessica.N.Vincent@uth.tmc.edu', 'phone': '713-486-2645'}], 'overallOfficials': [{'name': 'Heather Webber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Heather E. Webber, PhD', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}