Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder
NCT ID: NCT05833529
Last Updated: 2024-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2023-05-01
2025-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VRCET for Cocaine Craving then MFCT
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.
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 ≤ 3/10; 0 = none; 10 = very high). Meetings end with relaxation/relapse 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.
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).
PCET for Cocaine Craving
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.
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 ≤ 3/10; 0 = none; 10 = very high). Meetings end with relaxation/relapse 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.
Interventions
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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 ≤ 3/10; 0 = none; 10 = very high). Meetings end with relaxation/relapse 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.
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).
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 ≤ 3/10; 0 = none; 10 = very high). Meetings end with relaxation/relapse 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Laboratoire de Psychologie des Cognitions (Strasbourg University, France)
UNKNOWN
ICube Laboratory - Team IGG (Strasbourg University, France)
UNKNOWN
Hospital Center of Saint-Esprit (Martinique)
UNKNOWN
National Cancer Institute, France
OTHER_GOV
French Institute for Public Health Research (IReSP)
UNKNOWN
GIRCI SOHO
OTHER
Thomas Lehoux
OTHER
Responsible Party
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Thomas Lehoux
Ph.D. Candidate
Principal Investigators
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Jérôme LACOSTE, MD
Role: PRINCIPAL_INVESTIGATOR
CHU of Martinique
Thomas LEHOUX, Ph.D. Candidate
Role: STUDY_DIRECTOR
Laboratoire de Psychologie des Cognitions (Strasbourg University, France)
Locations
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University Hospital Center of Martinique
Fort-de-France, , Martinique
Hospital Center of Saint-Esprit (Martinique)
Saint-Esprit, , Martinique
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Lehoux T, Capobianco A, Lacoste J, Rollier S, Mopsus Y, Melgire M, Lecuyer F, Gervilla M, Weiner L. Virtual reality cue-exposure therapy in reducing cocaine craving: the Promoting Innovative COgnitive behavioral therapy for Cocaine use disorder (PICOC) study protocol for a randomized controlled trial. Trials. 2024 Jun 27;25(1):421. doi: 10.1186/s13063-024-08275-7.
Other Identifiers
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2022-A02440-43
Identifier Type: REGISTRY
Identifier Source: secondary_id
22_RIPH2-18
Identifier Type: -
Identifier Source: org_study_id
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