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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Change from Baseline Cocaine Craving Frequency (Last 14 Days) at the End of Treatment
研究概览
简要总结
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.
So 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.
To 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age greater than or equal to 18),
- •Present the diagnostic criteria for a cocaine use disorder (DSM-5; SCID 5-CV),
- •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,
- •Present a motivation of "action" or "maintenance" of cocaine use cessation (University of Rhode Island Change Assessment Scale),
- •Have been informed of the research,
- •Have given free, informed and express consent,
- •Be affiliated to a social security scheme.
排除标准
- •Present the diagnostic criteria (MINI 5.0.0.; DSM-IV):
- •Current high suicide risk episode,
- •Current psychotic syndrome,
- •Current mania or hypomania episode,
- •Current post-traumatic stress
- •Present significant symptoms of cyberkinetosis in virtual reality exposure (SP-IE),
- •Present another current medical condition at risk of danger or inability to comply with the protocol (e.g. heart problems, blindness or deafness,...),
- •Be placed under legal safeguard, guardianship or curatorship,
- •Patient who refused to participate in the study,
- •Pregnant or breastfeeding women.
结局指标
主要结局
Change from Baseline Cocaine Craving Frequency (Last 14 Days) at the End of Treatment
时间窗: Right before treatment and at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3)
Self-reported retrospective cocaine craving frequency in the last 14 days according to the Craving Expérience Questionnaire (french version; CEQ-F "A Quelle Fréquence" total score; Ceschi et Pictet, 2018). CEQ-F "A Quelle Fréquence" total score varies from 11 to 111 (higher score suggesting higher craving frequency). CEQ-F "A Quelle Fréquence" focuses on the frequence of cocaine craving in the last 14 days.
Change from Baseline Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving) at the End of Treatment
时间窗: Right before treatment and at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3)
Self-reported cocaine craving intensity in virtuo exposure to cocaine craving according to the Craving Expérience Questionnaire (french version; CEQ-F "Envie la Plus Forte" total score; Ceschi et Pictet, 2018). CEQ-F "Envie la Plus Forte" total score varies from 11 to 111 (higher score suggesting higher craving intensity). CEQ-F "Envie la Plus Forte" is administrated immediatly after a standard 5 mins virtual reality cue exposure for cocaine craving and focuses on the strongest cocaine craving felt during the exposure. The virtual reality cue exposure environment is different from the one to which participants were exposed during treatment, in contrary to VR settings which are similar.
次要结局
- Negatives and Positive Emotional States (in Virtual Reality Cue Exposure for Cocaine Craving)(Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Spatial Presence, Sense of Reality and Cybersickness related to Cue Exposure Environments for Cocaine Craving(Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced)
- Cocaine Craving Occurence, Imagery and Intrusiveness Frequency (Last 14 Days)(Right before treatment; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Self-Efficacy to Cope with Cocaine Craving without Using (in Virtual Reality Cue Exposure for Cocaine Craving)(Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Blood Volume Pulse and Skin Temperature (in Virtual Reality Cue Exposure for Cocaine Craving)(Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Ecological Validity related to Cue Exposure Environments for Cocaine Craving(Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced)
- Propensity to Cocaine Relapse (Next 2 Months)(Right before treatment; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Emotions Dysregulation(Right before treatment; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving)(Right before treatment; at the end of each VR or pictures-based exposures during VRCET and PCET; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Cocaine Craving Frequency (Last 14 Days)(Right before treatment; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Cocaine Craving Occurence, Imagery and Intrusiveness Intensity (in Virtual Reality Cue Exposure for Cocaine Craving)(Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Client Satisfaction related to the Therapy(at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3))
- Dysfonctional Beliefs related to Cocaine Use(Right before treatment; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Abstinence from Cocaine Use (Retrospective)(Right before treatment; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
- Abstinence from Cocaine Use (Urine Drug Testing)(Right before treatment; at the end of "VRCET" and "PCET" 2 weeks (week 2); at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7))
研究者
Thomas Lehoux
Ph.D. Candidate
University Hospital Center of Martinique