Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder

NCT05833529 | Recruiting

• 2 other identifiers: 22_RIPH2-182022-A02440-43
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving) at the End of Treatment

  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.

  Right before treatment and at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3)

• Change from Baseline Cocaine Craving Frequency (Last 14 Days) at the End of Treatment

  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.

  Right before treatment and at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3)

Secondary Outcomes (15)

• 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 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)

• 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)

Study Arms (2)

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.

Behavioral: Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks; Other: Memory Focused Cognitive Therapy (MFCT) - 1 week

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.

Behavioral: Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks

Interventions

Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks BEHAVIORAL

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.

VRCET for Cocaine Craving then MFCT

Memory Focused Cognitive Therapy (MFCT) - 1 week OTHER

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).

VRCET for Cocaine Craving then MFCT

Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks BEHAVIORAL

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.

PCET for Cocaine Craving

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Lehoux: lead
• Laboratoire de Psychologie des Cognitions (Strasbourg University, France): collaborator
• ICube Laboratory - Team IGG (Strasbourg University, France): collaborator
• Hospital Center of Saint-Esprit (Martinique): collaborator
• National Cancer Institute, France: collaborator
• French Institute for Public Health Research (IReSP): collaborator
• GIRCI SOHO: collaborator

Study Sites (2)

University Hospital Center of Martinique

Fort-de-France, 97261, Martinique

RECRUITING

Hospital Center of Saint-Esprit (Martinique)

Saint-Esprit, 97270, Martinique

NOT YET RECRUITING

Related Publications (6)

• 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.

  PMID: 11860387 BACKGROUND

• 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.

  PMID: 12855083 BACKGROUND

• 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.

  PMID: 29478874 BACKGROUND

• 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.

  PMID: 25368571 BACKGROUND

• 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.

  PMID: 16516397 BACKGROUND

• 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.

  PMID: 38937824 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jérôme LACOSTE, MD

  CHU of Martinique

  PRINCIPAL INVESTIGATOR

• Thomas LEHOUX, Ph.D. Candidate

  Laboratoire de Psychologie des Cognitions (Strasbourg University, France)

  STUDY DIRECTOR

Central Study Contacts

Thomas LEHOUX, Ph.D. Candidate

CONTACT

06 66 33 78 41; thomas.lehoux@hotmail.fr

Jérôme LACOSTE, MD

CONTACT

05 96 59 25 72; jérôme.lacoste@chu-martinique.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. Candidate

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 27, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

MA (2)