Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-03 @ 7:34 AM
Study NCT ID:
NCT03606759
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2018-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Craving intensity (BILAN-7 jours)', 'timeFrame': '3 month', 'description': 'Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up'}], 'secondaryOutcomes': [{'measure': 'Adjusted Therapy Scale (ATI)', 'timeFrame': 'Week 1 to Week 11'}, {'measure': 'Addiction Severity Index (ASI)', 'timeFrame': 'Week 1 to Week 11', 'description': 'History and the severity of addiction'}, {'measure': 'Cues of each participant (QSA)', 'timeFrame': 'Week 1 to Week 11'}, {'measure': 'Mini International Neuropsychiatric Interview (MINI)', 'timeFrame': 'Week 1 to Week 11', 'description': 'Psychiatric comorbidities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Addiction', 'High-risk relapse situation', 'Craving', 'Individual cues', 'Individually tailored treatment'], 'conditions': ['Addictive Behavior', 'Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.', 'detailedDescription': 'Addiction is one of the most prevalent psychiatric disorders in general population. In the DSM-5, substance abuse and substance dependence have been combined into a single substance use disorder and gambling disorder is now reclassified in the new substance-related and addictive disorders category. Moreover, a criterion assessing the craving has been added. The management of craving is an important focus of addiction treatment as craving is often linked to relapse. Several cues could precipitate the craving. Some of them are substance-related or gambling-related, some other are more person-specific. Recent studies have revealed that those "individual cues" are highly predictive of craving and relapse, and suggest that they are involved in addiction chronicity. The awareness of these cues and the intensity of the craving are important to tailor a better treatment adapted to the patient\'s need in order to prevent relapse. The aim of this study is to evaluate the efficacy of a program that includes an Individually Adjusted Therapy scale (ATI) to help the clinician to modulate the level of care regarding of the patient\'s risk of relapse (based on cues, intensity and frequency of the craving). The study will consist in a randomized controlled trial comparing 2 groups of participants that are seeking treatment for substance use disorder (alcohol, opiates, tobacco, cannabis, cocaine or any other substance) or behavioral addiction in an outpatient addiction clinics in France (four inclusion sites).\n\nAll the participants will be assessed with several questionnaires that evaluate the history and the severity of addiction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 18 years old or older\n* Meet DSM-5 substance use disorder diagnosis for at least one substance (alcohol, tobacco, cannabis, opiates, cocaine or any other substance) use disorder or behavioral addiction (gambling, screens, video games, food addiction, sex addiction, compulsive purchases), currently not stabilized\n* Seek treatment for this a substance use disorder or behavioral addiction\n* Beginning (or re-initiating) multi-month outpatient care for this disorder in one of the inclusion centres.\n* Ability to identify a priority substance/behavior, as main object of treatment, in case of simultaneous treatment on several addictions\n* Beneficiary of the French Social Security system\n* Give an informed consent to participate\n\n o Exclusion criteria:\n* Severe physical or psychiatric or addictologic condition that prevents an outpatient treatment\n* Severe physical or psychiatric condition that prevents to complete the assessment\n* Addictive disorder that requires several treatment for several substance use disorder simultaneously\n* Difficulty to understand and to write French\n* Could not be reachable by phone\n* Participate to another study that prevents to participate to another research\n* Prisoner\n* Person under law protection\n* Person under legal guardianship'}, 'identificationModule': {'nctId': 'NCT03606759', 'acronym': 'AjusT', 'briefTitle': 'Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity of Patients in Treatment for a Substance Use Disorder or a Behavioral Addiction. A Multicenter Randomized Controlled Trial (AjusT)', 'orgStudyIdInfo': {'id': 'CHUBX 2014/43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traitment as usual adjusted on ATI information', 'description': 'Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.', 'interventionNames': ['Procedure: Weekly assessment ajusted']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traitment as usual', 'description': 'Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.', 'interventionNames': ['Procedure: Weekly assessment']}], 'interventions': [{'name': 'Weekly assessment', 'type': 'PROCEDURE', 'description': 'Weekly assessment during 3 months :\n\nSeverity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours)', 'armGroupLabels': ['Traitment as usual']}, {'name': 'Weekly assessment ajusted', 'type': 'PROCEDURE', 'description': 'Weekly assessment during 3 months :\n\nSeverity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours) Individually Adjusted Therapy scale (ATI)', 'armGroupLabels': ['Traitment as usual adjusted on ATI information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Centre Hospitalier Charles Perrens', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '87 025', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Esquirol', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '97 405', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire La Réunion', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}], 'overallOfficials': [{'name': 'Mélina Fatseas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}