Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT07119567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Cocaine Use and Withdrawal on Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Efficiency (%) measured by polysomnography', 'timeFrame': '30 months', 'description': 'Sleep efficiency, defined as the ratio of total sleep time to time spent in bed, will be assessed using the Somfit® wearable device. Measurements will be conducted over three visits corresponding to distinct stages of cocaine use and withdrawal: V1 (active use), V2 (early withdrawal), and V3 (late withdrawal). Each visit includes two consecutive nights of recording, and the 2 nights will be averaged for analysis purposes. This double recording also makes it possible to obtain data from one night if the second encounters a technical problem. The primary outcome will be derived from data collected over a 16-hour window encompassing the nocturnal sleep period.'}], 'secondaryOutcomes': [{'measure': 'Objective Sleep Parameters measured by polysomnography', 'timeFrame': '30 months', 'description': 'Objective sleep metrics including total sleep time (min), sleep onset latency (min), wake after sleep onset (WASO, min), REM sleep duration and latency, time spent in N1, N2, N3 stages (min and %), micro-arousal index, phasic/tonic REM proportions, spindle index in NREM sleep, and delta power during N3 will be recorded via polysomnography (SOMFIT) across three study visits (each comprising two nights of measurement).'}, {'measure': 'Sleep-Wake Rhythm Parameters from Actigraphy', 'timeFrame': '30 months', 'description': 'Actigraphy data from the MotionWatch 8® will be used to assess weekly sleep-wake patterns. Extracted parameters include sleep onset and offset times, sleep midpoint, time in bed, total sleep time, sleep onset latency, WASO, sleep efficiency, and diurnal naps (presence, number, duration, and timing).'}, {'measure': 'Sleep-Wake Rhythm Parameters from Sleep Diary', 'timeFrame': '30 months', 'description': 'Entries in the sleep diary will be used to assess weekly sleep-wake patterns'}, {'measure': 'Subjective Sleep Scores', 'timeFrame': '30 months', 'description': 'Sleep-related self-reported outcomes will be assessed using the following validated questionnaires completed after polysomnography nights.'}, {'measure': 'Circadian Rhythmicity via Urinary Cortisol', 'timeFrame': '30 months', 'description': 'Circadian rhythm will be evaluated by analyzing sequential urinary samples (5/24h) for free cortisol levels at two withdrawal phases: early withdrawal (Visit 2) and late withdrawal (Visit 3).'}, {'measure': 'Circadian Rhythmicity via Melatonin Metabolites', 'timeFrame': '30 months', 'description': 'Circadian rhythm will be evaluated by analyzing sequential urinary samples (5/24h) for 6-sulfatoxymelatonin levels at two withdrawal phases: early withdrawal (Visit 2) and late withdrawal (Visit 3).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cocaine use disorder', 'Withdrawal', 'Sleep', 'Polysomnography', 'Actimetry'], 'conditions': ['Cocaine Use Disorder']}, 'descriptionModule': {'briefSummary': "This study investigates how cocaine use and withdrawal affect sleep and circadian rhythms in individuals undergoing inpatient detoxification. Using wearable sleep monitors, actigraphy, questionnaires, and hormonal biomarkers, it aims to capture both objective and subjective changes in sleep across three key stages: active use, early withdrawal, and late withdrawal. The study is unique in its ability to explore sleep microstructure, the circadian system's role via melatonin and cortisol measurements, and the dynamic relationship between subjective sleep perception and objective sleep data. It also examines whether sleep quality may serve as a predictive marker of long-term withdrawal success.", 'detailedDescription': 'Sleep disturbances are a common but poorly understood feature of cocaine use disorder, and may play a critical role in both relapse vulnerability and treatment outcomes. This interventional study aims to explore objective and subjective sleep patterns, as well as circadian regulation, across three distinct phases: during active cocaine use, early withdrawal, and late withdrawal. Participants will be individuals scheduled for supervised inpatient detoxification.\n\nThe study employs a multimodal assessment strategy:\n\n* Ambulatory polysomnography using the Somfit® device will allow analysis of both macro- and microstructure of sleep across two nights per visit.\n* Actigraphy will be used to capture precise temporal dynamics of sleep-wake rhythm over the course of the study.\n* Subjective measures will include validated self-report questionnaires on sleep quality, insomnia severity, sleepiness, fatigue, and sleep perception.\n* Urinary biomarkers (free cortisol and 6-sulfatoxymelatonin, collected 5 times/day) will provide data on circadian rhythm integrity, enabling exploration of the role of circadian dysregulation in sleep disturbances.\n\nA key originality of the study lies in its ability to dynamically assess the relationship between subjective and objective sleep parameters and to explore the circadian contribution to sleep disruption in cocaine users. Furthermore, by following patients through early and late withdrawal, the study will investigate whether sleep parameters could serve as predictive markers of long-term withdrawal success, offering potential targets for future therapeutic interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cocaine use disorder seeking hospitalization for withdrawal', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 years or older\n* Meeting DSM-5 criteria for cocaine use disorder\n* Positive urine drug screen for cocaine\n* Scheduled for inpatient supervised cocaine detoxification within the next four weeks\n* Covered by a national health insurance plan or social security system\n* Have a valid, personal means of contact (telephone or email address) enabling remote follow-up at 6 months.\n\nExclusion Criteria:\n\n* Current diagnosis of opioid use disorder or other psychostimulant use disorders (e.g., amphetamines, methamphetamines, cathinones, methylphenidate)\n* Unstable psychiatric disorder or somatic illness deemed incompatible with study participation by the investigator\n* Current treatment with methylphenidate, modafinil, solriamfetol, melatonin, pitolisant, naltrexone, or bupropion\n* Patients under legal guardianship\n* Pregnant or breastfeeding women: a pregnancy test will be performed prior to inclusion for women of childbearing potential\n* Individuals deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT07119567', 'acronym': 'CokeSo', 'briefTitle': 'Impact of Cocaine Use and Withdrawal on Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': 'Longitudinal Exploration of Subjective and Objective Sleep Characteristics in Patients With Cocaine Use Disorder During the Withdrawal Process', 'orgStudyIdInfo': {'id': '2025-A00292-47'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cocaine Use Disorder Group', 'description': 'A cohort of 32 patients with cocaine use disorder will undergo repeated sleep assessment at three key stages: during active use, at the beginning of withdrawal, and after a period of sustained withdrawal. All participants will serve as their own control across timepoints', 'interventionNames': ['Other: Multimodal Sleep and Biomarker Assessment']}], 'interventions': [{'name': 'Multimodal Sleep and Biomarker Assessment', 'type': 'OTHER', 'description': 'Participants will undergo non-invasive sleep assessments including polysomnography recordings (using the Somfit® device), actigraphy, self-reported questionnaires (on sleep, substance use), and urinary biomarker collection (for cortisol and melatonin levels) at three distinct stages of their substance use/withdrawal timeline.', 'armGroupLabels': ['Cocaine Use Disorder Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ILONA MEDIGUE, PhD student', 'role': 'CONTACT', 'email': 'ilona.medigue@ch-le-vinatier.fr', 'phone': '00334 37 91 55 65'}, {'name': 'VERONIQUE VIAL, PM', 'role': 'CONTACT', 'email': 'veronique.vial@ch-le-vinatier.fr', 'phone': '00334 37 91 55 22'}], 'overallOfficials': [{'name': 'BENJAMIN ROLLAND, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier le Vinatier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}