Clinical trial NCT05833529: Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cocaine Use Disorder
Keywords: Cocaine
Virtual Reality Cue Exposure Therapy
Craving
Cognitive and Behavioral Therapy
Cue Exposure Therapy
Memory Focused Cognitive Therapy
Substance Use Disorder
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie des Cognitions (Strasbourg University, France)
name: ICube Laboratory - Team IGG (Strasbourg University, France)
name: Hospital Center of Saint-Esprit (Martinique)
name: National Cancer Institute, France
name: French Institute for Public Health Research (IReSP)
name: GIRCI SOHO
First posted: 2023-04-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving) at the End of Treatment
timeFrame: Right before treatment and at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3)
measure: Change from Baseline Cocaine Craving Frequency (Last 14 Days) at the End of Treatment
timeFrame: Right before treatment and at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3)
Secondary outcomes:
measure: Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving)
timeFrame: 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)
measure: Cocaine Craving Frequency (Last 14 Days)
timeFrame: 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)
measure: Cocaine Craving Occurence, Imagery and Intrusiveness Frequency (Last 14 Days)
timeFrame: 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)
measure: Cocaine Craving Occurence, Imagery and Intrusiveness Intensity (in Virtual Reality Cue Exposure for Cocaine Craving)
timeFrame: Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7)
measure: Negatives and Positive Emotional States (in Virtual Reality Cue Exposure for Cocaine Craving)
timeFrame: Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7)
measure: Self-Efficacy to Cope with Cocaine Craving without Using (in Virtual Reality Cue Exposure for Cocaine Craving)
timeFrame: Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7)
measure: Blood Volume Pulse and Skin Temperature (in Virtual Reality Cue Exposure for Cocaine Craving)
timeFrame: Right before treatment; at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3); 1 month post treatment (week 7)
measure: Spatial Presence, Sense of Reality and Cybersickness related to Cue Exposure Environments for Cocaine Craving
timeFrame: Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced
measure: Ecological Validity related to Cue Exposure Environments for Cocaine Craving
timeFrame: Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced
measure: Propensity to Cocaine Relapse (Next 2 Months)
timeFrame: 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)
measure: Dysfonctional Beliefs related to Cocaine Use
timeFrame: 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)
measure: Abstinence from Cocaine Use (Retrospective)
timeFrame: 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)
measure: Abstinence from Cocaine Use (Urine Drug Testing)
timeFrame: 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)
measure: Emotions Dysregulation
timeFrame: 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)
measure: Client Satisfaction related to the Therapy
timeFrame: 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)
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: University Hospital Center of Martinique
city: Saint-Esprit
country: Martinique
facility: Hospital Center of Saint-Esprit (Martinique)
Study officials:
affiliation: CHU of Martinique
name: Jérôme LACOSTE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratoire de Psychologie des Cognitions (Strasbourg University, France)
name: Thomas LEHOUX, Ph.D. Candidate
role: STUDY_DIRECTOR
References:
citation: Conklin CA, Tiffany ST. Applying extinction research and theory to cue-exposure addiction treatments. Addiction. 2002 Feb;97(2):155-67. doi: 10.1046/j.1360-0443.2002.00014.x.
citation: Lee JH, Ku J, Kim K, Kim B, Kim IY, Yang BH, Kim SH, Wiederhold BK, Wiederhold MD, Park DW, Lim Y, Kim SI. Experimental application of virtual reality for nicotine craving through cue exposure. Cyberpsychol Behav. 2003 Jun;6(3):275-80. doi: 10.1089/109493103322011560.
citation: Marsden J, Goetz C, Meynen T, Mitcheson L, Stillwell G, Eastwood B, Strang J, Grey N. Memory-Focused Cognitive Therapy for Cocaine Use Disorder: Theory, Procedures and Preliminary Evidence From an External Pilot Randomised Controlled Trial. EBioMedicine. 2018 Mar;29:177-189. doi: 10.1016/j.ebiom.2018.01.039. Epub 2018 Feb 2.
citation: Hone-Blanchet A, Wensing T, Fecteau S. The use of virtual reality in craving assessment and cue-exposure therapy in substance use disorders. Front Hum Neurosci. 2014 Oct 17;8:844. doi: 10.3389/fnhum.2014.00844. eCollection 2014.
citation: Saladin ME, Brady KT, Graap K, Rothbaum BO. A preliminary report on the use of virtual reality technology to elicit craving and cue reactivity in cocaine dependent individuals. Addict Behav. 2006 Oct;31(10):1881-94. doi: 10.1016/j.addbeh.2006.01.004. Epub 2006 Mar 3.