[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503305":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":45,"locations":55,"responsibleParty":88,"collaborators":92,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":27,"enrollmentInfo":115,"targetDuration":27,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":57,"whyStopped":27,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"University Hospital Center of Martinique","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"VRCET for Cocaine Craving then MFCT","EXPERIMENTAL","3 weeks treatment consisting of 10 meetings of Virtual Reality Cue Exposure Therapy (VRCET) for cocaine craving, followed by 5 meetings of Memory Focused Cognitive Therapy (MFCT). All meetings will last 90 minutes. VRCET meetings will take place in a 2 weeks period (weeks 1 and 2) at a daily frequency from monday to friday included. MFCT meetings will take place in the 1 week period following VRCET (week 3) at a daily frequency from monday to friday included.",[13,14],"Behavioral: Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks","Other: Memory Focused Cognitive Therapy (MFCT) - 1 week",{"label":16,"type":17,"description":18,"interventionNames":19},"PCET for Cocaine Craving","ACTIVE_COMPARATOR","3 weeks treatment consisting of 15 meetings of Picture-based Cue Exposure Therapy (PCET) for cocaine craving. All meetings will last 90 minutes. PCET meetings will take place in a 3 weeks period (weeks 1 to week 3) at a daily frequency from monday to friday included.",[20],"Behavioral: Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks","40 10 mins VRCEs for cocaine craving (desensitization to only cocaine craving cues; no others interventions). 4 VRCE and 2 different VRCE situations by meeting. Same VRCE situations spaced intra (30 mins) and inter meetings (48 hrs). 5 standard VRCE situations (appearance and dialogues adapted to Martinique field) varying from \"only peers cocaine use talk\" to \"peers and participant prepare and use cocaine\" and ranging from the lowest to the highest participant related cocaine craving level. Situation switch to another when its initial cocaine craving level has decreased to its half for 5 continuous VRCE mins (must be ≤ 3\u002F10; 0 = none; 10 = very high). Meetings end with relaxation\u002Frelapse prevention in any case of distress still over convenient levels. VRCE use Meta Quest 2, are visuo-auditively immersive (360°; 1st person), interactive (using virtual objects), semi-stationnary (360°-rotating stool and teleportation system). Participant skin color and cocaine using mode individualized.",[9],null,{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Memory Focused Cognitive Therapy (MFCT) - 1 week","In accordance with the \"Memory Focused Cognitive Therapy for Cocaine Use Disorder\" Therapist Guide (Marsden and Goetz, 2018), MFCT meetings will consist in 5 sequential components: Cognitive case conceptualisation of cocaine use disorder maintaining processes to inform a treatment plan; Education about cocaine's cognitive and physical effects; Cocaine related cue-induction to elicit images and affective responses; Memory reconsolidation procedures; Standard CBT techniques (e.g. behavioural experiments of cocaine-related expectancies and skills for adaptive emotion regulation).",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks","60 x 10 mins PCE (desensitization to only cocaine craving cues; no others interventions). A standard audio of VRE songs is played in PCE. 4 PCE and 2 different PCE situations by meeting. Same PCE situations spaced intra (30 mins) and inter meetings (48 hrs). 5 standard PCE situations (appearance and dialogues adapted to Martinique field) varying from \"only peers cocaine use talk\" to \"peers and participant prepare and use cocaine\" and ranging from the lowest to the highest participant related cocaine craving level. Situation switch to another when its initial cocaine craving level has decreased to its half for 5 continuous PCE mins (must be ≤ 3\u002F10; 0 = none; 10 = very high). Meetings end with relaxation\u002Frelapse prevention if any distress over convenient levels. PCE use a laptop standard PowerPoint slide show (2D pictures from VRCE; non-spatialized audio from laptop speakers), are non-interactive (seated on a stool). Participant skin color and cocaine using mode individualized.",[16],[37,41],{"name":38,"affiliation":39,"role":40},"Jérôme LACOSTE, MD","CHU of Martinique","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":44},"Thomas LEHOUX, Ph.D. Candidate","Laboratoire de Psychologie des Cognitions (Strasbourg University, France)","STUDY_DIRECTOR",[46,51],{"name":42,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","06 66 33 78 41","+33","thomas.lehoux@hotmail.fr",{"name":38,"role":47,"phone":52,"phoneExt":53,"email":54},"05 96 59 25 72","+596","jérôme.lacoste@chu-martinique.fr",[56,72],{"facility":5,"status":57,"city":58,"state":27,"zip":59,"country":60,"countryCode":27,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Fort-de-France","97261","Martinique",{"type":62,"coordinates":63},"Point",[64,65],-61.07418,14.60365,{"lat":65,"lon":64},[68,69,70],{"name":42,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":38,"role":40,"phone":27,"phoneExt":27,"email":27},{"name":42,"role":71,"phone":27,"phoneExt":27,"email":27},"SUB_INVESTIGATOR",{"facility":73,"status":74,"city":75,"state":27,"zip":76,"country":60,"countryCode":27,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Hospital Center of Saint-Esprit (Martinique)","NOT_YET_RECRUITING","Saint-Esprit","97270",{"type":62,"coordinates":78},[79,80],-60.93333,14.55,{"lat":80,"lon":79},[83,87],{"name":84,"role":47,"phone":85,"phoneExt":53,"email":86},"Manuela MELGIRE, Ph.D.","05 96 77 31 11","manuela.pedrera-melgire@ch-saint-esprit.fr",{"name":84,"role":40,"phone":27,"phoneExt":27,"email":27},{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Thomas Lehoux","Ph.D. Candidate",[93,95,97,98,101,103],{"name":43,"class":94},"UNKNOWN",{"name":96,"class":94},"ICube Laboratory - Team IGG (Strasbourg University, France)",{"name":73,"class":94},{"name":99,"class":100},"National Cancer Institute, France","OTHER_GOV",{"name":102,"class":94},"French Institute for Public Health Research (IReSP)",{"name":104,"class":6},"GIRCI SOHO","100503305","innovative-cognitive-and-behavioral-psychotherapy-for-cocaine-use-disorder-100503305",false,"NCT05833529","Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder","Virtual Reality Cue Exposure Therapy for Cocaine Craving: an Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder (Psychothérapie Innovante COmportementale et Cognitive Pour le Trouble d'Usage de Cocaïne; PICOC)","PICOC","Inclusion Criteria:\n\n* Adult patients (age greater than or equal to 18),\n* Present the diagnostic criteria for a cocaine use disorder (DSM-5; SCID 5-CV),\n* Be voluntarily hospitalized and engaged in a residential standard treatment for cocaine use disorder at the Universitary Hospital of Martinique or at the Hospital Centre of Saint-Esprit in Martinique,\n* Present a motivation of \"action\" or \"maintenance\" of cocaine use cessation (University of Rhode Island Change Assessment Scale),\n* Have been informed of the research,\n* Have given free, informed and express consent,\n* Be affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Present the diagnostic criteria (MINI 5.0.0.; DSM-IV):\n\n  * Current high suicide risk episode,\n  * Current psychotic syndrome,\n  * Current mania or hypomania episode,\n  * Current post-traumatic stress\n* Present significant symptoms of cyberkinetosis in virtual reality exposure (SP-IE),\n* Present another current medical condition at risk of danger or inability to comply with the protocol (e.g. heart problems, blindness or deafness,...),\n* Be placed under legal safeguard, guardianship or curatorship,\n* Patient who refused to participate in the study,\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":116,"type":117},54,"ESTIMATED","INTERVENTIONAL",[120],"NA","Cocaine is the 2nd most used illicit substance in Europe and its use implies numerous health complications as well as an annual social cost of 8.7 G d'€. Classical (picture, video, audio, imagery based or in vivo) cue exposure therapy for substance craving (CET), i.e. the irrepressible and non-voluntary desire to use the substance, failed to prove efficacious in treating substance use disorder. Virtual reality cue exposure therapy for substance craving (VRCET), is more immersive, realistic and controllable, and is suggested as being a more efficacious intervention in reducing craving as compared to classical CET.\n\nSo far it's still not known, thus the secondary aim of the present randomized and clinical trial is to investigate, whether virtual reality cue exposure is more efficacious, as compared to classical cue exposure, in both eliciting and reducing cocaine craving in a clinical context of CET for cocaine craving. The main study aim to is to investigate whether a VRCET for cocaine craving based cognitivo-behavioral therapy (i.e. VRCET followed by memory focused cognitive therapy) is more efficacious than a behavioural therapy (i.e. classical exposure therapy to craving) in reducing cocaine craving.\n\nTo do so, 54 voluntary residential patients in treatment for cocaine use disorder will be recruited from the Universitary Hospital Center of Martinique (CHUM, Martinique, France) and Saint-Esprit Hospital Center (CHSE, Martinique, France) and randomly allocated in either a 3 weeks individual experimental treatment (10 meetings of VRET for cocaine craving followed by 5 meetings of memory focused cognitive therapy) or a 3 weeks individual control treatment (15 meetings of pictures based exposure therapy for cocaine craving). Self-reported measures of retrospective (last 14 days) and in virtuo exposure cocaine craving will be collected at the beginning, after 10 days, after 15 days of treatment and 1 month post. Others secondary subjective, urinary and physiological cocaine use related measures will also be collected.",[123],"Cocaine Use Disorder",[125,126,127,128,129,130,131],"Cocaine","Virtual Reality Cue Exposure Therapy","Craving","Cognitive and Behavioral Therapy","Cue Exposure Therapy","Memory Focused Cognitive Therapy","Substance Use Disorder","2024-06-07",{"date":134,"type":135},"2024-06-10","ACTUAL",{"date":137,"type":135},"2023-05-01",{"date":139,"type":117},"2025-05",{"name":90,"class":6},2]