Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT07202351
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised pilot clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence', 'timeFrame': 'M6: 6 months after inclusion', 'description': 'Abstinence to the substance (tobacco or cannabis, or both) defined by the absence of use of tobacco / cannabis products over the 6 month period after inclusion. Abstinence will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.'}], 'secondaryOutcomes': [{'measure': 'Relapse', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Relapse rate. Relapse is defined as ≥ 7 consecutive days of smoking tobacco or cannabis. Relapse will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.'}, {'measure': 'Abstinence number of days', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Longest period (number of consecutive days) without substance use, which will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.'}, {'measure': 'Consumption number of days', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Longest period (number of consecutive days) with substance use, which will be assessed with the Timeline Followback (TLFB), a self-reported calendar of substance consumption.'}, {'measure': 'Carbon monoxide', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Exhaled carbon monoxide test to monitor CO to assess objectively smoking level'}, {'measure': 'Insomnia', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'The severity of insomnia will be measured with the Insomnia Severity Index (ISI). Total score ranges from 0-28. INterpretation of the score 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)'}, {'measure': 'Sleep quality', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). Total score ranges form 0 (better) to 21 (worse) sleeping quality.'}, {'measure': 'Sleepiness', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Sleepiness will be evaluated with the Epworth Sleepiness Scale, which ranges from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness and from 11 to 24 indicates excessive (abnormal) daytime sleepiness.'}, {'measure': 'Medication', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Patients will be asked if they take any medication to help reduce their sleep disorders (hypnotics, melatonin, etc.).'}, {'measure': 'Anxiety and depression', 'timeFrame': 'M1: 1 month after inclusion M3: 3 months after inclusion M6 : 6 months after inclusion', 'description': 'Anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression scale (HADs).\n\nThere are two scores for items in each subscale : anxiety score (HADS-A) and depression score (HADS-D). Total score ranging from 0-21 for each subscale. A higher score indicates higher distress. Usually, a cut-off score of 11 for the total HADS, and 8 for the HADS-D are used.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep disorder', 'tobacco', 'cannabis', 'addiction'], 'conditions': ['Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'During a cessation therapy for tobacco or cannabis, sleep disorders are one of the main risk factors of relapse, and a symptom of substance withdrawing. In this study, we make the hypothesis that identifying and managing potential sleep disorders during cessation treatment may contribute to maintain tobacco / cannabis abstinence on the long-term. To evaluate the impact of such intervention, we will conduct a randomised pilot study among patients consulting at two addiction prevention and care centres, for smoking or cannabis use cessation treatment. Control group will benefit of usual care (a multidisciplinary care with individual and group therapies); intervention group will benefit in addition of a systematic screening of sleep disorders, and in case of a diagnosed alteration, they will be addressed to the Chronos centre, for specific care to help them manage and reduce the consequences of their sleep disorders. Participants will be followed over a 6-month period, with visits at 1 and 3 months, to monitor smoking or cannabis cessation, and other criteria associated with their substance use or sleep.', 'detailedDescription': 'Smoking is a serious public health issue in France, with one quarter of the population who smokes on a daily base. Tobacco use represents the first avoidable death cause. Cannabis, often use with tobacco, is the most frequent drug use, worldwide and with a prevalence of 3.2% of regular users in France, including 2.1% of daily users. Both substances are associated with sleep disorders; for instance, nicotine has several side effects, such as a negative impact on sleep quality and structure. During cessation therapy, sleep disorders were identified as a risk factor of relapse and one of the main lasting symptoms. Therefore, relation between addiction and sleep disorders seem to be bidirectional, potentially increasing the impact of each other. Screening and managing sleep disorders as a preventive measure to avoid relapse represents an improvement during smoking or cannabis use cessation treatment.\n\nThe main objective of the study is to evaluate the impact of a specific intervention targeting sleep disorders during tobacco or cannabis cessation therapy. We will conduct a randomised pilot study among patients presenting at two participating addiction prevention and care centres, for smoking or cannabis use cessation treatment. Patients who are eligible and agree to participate will be randomised in either control group, and will benefit of the usual care, or intervention group, and will benefit in addition of a systematic and standardised screening of sleep disorders, and specific care at the Chronos centre, if any disorder is diagnosed.\n\nPatients will be followed over a 6-month period, with two visits at 1 and 3 months, to monitor indicators related to substance consumption and sleep. The impact of the targeted intervention will be evaluate based on the abstinence duration over the 6 months, calculated on the total number of days without tobacco / cannabis use. We will also collect other information that can be associated with the success or failure of cessation therapy, such as depressive symptoms, anxiety disorders, the use of other psychoactive substances (alcohol for instance), other psychiatric disorder, etc.\n\nQuestions on sleep will be asked to patients in the control group, to assess comparability of both groups throughout the study. This pilot trial will allow us to determine the feasibility and efficacy of a targeted intervention on sleep disorders during smoking or cannabis use cessation therapy, in order to generalise such care in the usual practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years old\n* presenting at the participating addiction treatment centres for a smoking or cabannis use cessation therapy\n* who agree to participate to the study\n* affiliated to the French health insurance system\n\nExclusion Criteria:\n\n* Patients hospitalised during the cessation therapy\n* Patients undergoing sleep disorders treatment\n* Patients participating to another study\n* Patients with psychotic disorders (according the DSM-5 classification)\n* Patients who do not want the additionnal intervention and care if randomised in the intervention group'}, 'identificationModule': {'nctId': 'NCT07202351', 'acronym': 'ISAC', 'briefTitle': 'Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier St Anne'}, 'officialTitle': 'Impact of an Intervention Targeting Sleep Disorders During Tobacco or Cannabis Cessation Therapy: a Randomised Pilot Study', 'orgStudyIdInfo': {'id': 'D22_EPI0029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Contrôle', 'description': 'In the control group, patients benefit from care as usual in one of the two addiction prevention and care clinics.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'In the intervention group, patients will be benefit, in addition to the usual care of the smoking / tobacco cessation therapy, from a specific intervention to screen and care for sleep disorders, at the Chronos centre.', 'interventionNames': ['Other: Screening and management of sleep disorders']}], 'interventions': [{'name': 'Screening and management of sleep disorders', 'type': 'OTHER', 'description': 'Patients in the intervention group will undergo a systematic and standardised screening of sleep disorders. If any trouble is identified, a specific treatment plan is offered at the Chronos centre, including for instance, cognitive behavioural therapy for insomnia, or nightmares will be treated with Image Rehearsal Therapy (IRT).', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne PEROZZIELLO, PhD', 'role': 'CONTACT'}], 'facility': 'GHU Paris Psychiatrie et Neurosciences', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Anne PEROZZIELLO', 'role': 'CONTACT', 'email': 'a.perozziello@ghu-paris.fr', 'phone': '01.80.52.67.54'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be provided upon reasonable request addressed to the investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier St Anne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University professor and Hospital practitioner', 'investigatorFullName': 'Pierre Alexis GEOFFROY', 'investigatorAffiliation': 'Centre Hospitalier St Anne'}}}}