Cocaine Use DisorderPICOCNCT05833529

Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder

A study testing Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks, Memory Focused Cognitive Therapy (MFCT) - 1 week and Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks in people with Cocaine Use Disorder, run by Thomas Lehoux at 2 sites in Martinique.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cocaine Use Disorder
What is being tested?: Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks, Memory Focused Cognitive Therapy (MFCT) - 1 week and Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesMartinique
Study dates: 1 May 2023to May 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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),

Show all 10Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

Thomas LEHOUX, Ph.D. Candidate contact

06 66 33 78 41 ext. +33

thomas.lehoux@hotmail.fr

Jérôme LACOSTE, MD contact

05 96 59 25 72 ext. +596

jérôme.lacoste@chu-martinique.fr

Martinique2 sites, 2 recruiting

University Hospital Center of Martinique
Fort-de-France, 97261
Thomas LEHOUX, Ph.D. Candidate, 06 66 33 78 41 ext. +33, thomas.lehoux@hotmail.fr
Jérôme LACOSTE, MD
Recruiting
Hospital Center of Saint-Esprit (Martinique)
Saint-Esprit, 97270
Manuela MELGIRE, Ph.D., 05 96 77 31 11 ext. +596, manuela.pedrera-melgire@ch-saint-esprit.fr
Manuela MELGIRE, Ph.D.
Not yet recruiting

Other trials in Martinique

About this study

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)

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
Being tested: Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks, Memory Focused Cognitive Therapy (MFCT) - 1 week, Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks
Keywords: Cocaine, Virtual Reality Cue Exposure Therapy, Craving, Cognitive and Behavioral Therapy, Cue Exposure Therapy, Memory Focused Cognitive Therapy, Substance Use Disorder
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeksBehavioural
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 weekOther
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 weeksBehavioural
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.

Study groups in NCT05833529
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Self-reported retrospective cocaine craving occurence, imagery and intrusiveness frequency in the last 14 days according to the Craving Expérience Questionnaire (french version; CEQ-F "A Quelle Fréquence" subscales total scores; Ceschi et Pictet, 2018). CEQ-F "A Quelle Fréquence" higher subscales total scores suggesting higher frequencies).
Measured: 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)
Self-reported cocaine craving occurence, imagery and intrusiveness intensity in virtuo exposure to cocaine craving according to the Craving Expérience Questionnaire (french version; CEQ-F "Envie la Plus Forte" subscales total scores; Ceschi et Pictet, 2018). CEQ-F "Envie la Plus Forte" higher subscales total scores suggesting higher intensities). CEQ-F "Envie la Plus Forte" subscales are 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.
Measured: 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)
Self-reported intensity of negative and positive emotional states in virtuo exposure to cocaine craving according to the Brief Mood Introspection Scale (french version; BMIS negative and positive subscales total scores; Dalle et al., 2003). BMIS higher subscales total scores suggesting higher intensities). BMIS subscales are administrated immediatly after a standard 5 mins virtual reality cue exposure for cocaine craving. 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.
Measured: Right before treatment; 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)
Self-reported efficacy to cope with cocaine craving in virtuo exposure to cocaine craving according to the Drug Taking Confidence Questionnaire 8D (french version; DTCQ-8D total score; Sklar et al., 1999). DTCQ-8D higher total score suggesting higher self-efficacy). DTCQ-8D is administrated immediatly after a standard 5 mins virtual reality cue exposure for cocaine craving. 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.
Measured: 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)
Blood volume pulse and skin temperature in virtuo exposure to cocaine craving according to PLUX Biosignals medically certificated devices (# ISO-13485; https://www.pluxbiosignals.com/pages/about). Blood volume pulse and skin temperature are recorded during a standard 5 mins virtual reality cue exposure for cocaine craving. 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.
Measured: 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
Self-reported spatial presence, sense of reality and cybersickness related to cue exposure environments according to the Spatial Presence for Immersive Environments (french version; SP-IE subscales total scores; Khenak et al., 2019). SP-IE subscales "sense of spatial presence", "the affordance of the environment", "the user's enjoyment", "the user's attention allocation to the task", "the sense of reality attributed to the environment", "the social embodiment with avatars", and "the possible negative effects of the environment (cybersickness)" are administrated immediatly after each new cue exposure environment experienced.
Measured: Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced
Ecological Validity related to Cue Exposure Environments for Cocaine Craving
Self-reported ecological validity related to cue exposure environments according to the Independant Television Commission - Sense Of Presence Inventory (french version; ITC-SOPI subscale total score; I2 Media Research Ltd, 2004; Independent Television Commission, 2000). The ITC-SOPI subscale "Ecological Validity/Naturalness" is administrated immediatly after each new cue exposure environment experienced.
Measured: Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced
Propensity to Cocaine Relapse (Next 2 Months)
Self-reported propensity to cocaine relapse in the next 2 months according to the Advance WArning of RElapse scale (french translated version; AWARE total score; Miller and Harris, 2000; Kelly and al., 2011).
Measured: 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)
Dysfonctional Beliefs related to Cocaine Use
Identification level to dysfunctional beliefs to cocaine use according to the Questionnaire of Core Beliefs related to Drug Use and Craving (french translated version; QBDU - Belief related to Addiction subscale total score; Martinez-Gonzalez et al., 2018).
Measured: 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)
Self reported retrospective measure of abstinence from cocaine use in the last 14 days according to the Timeline Followback (french translated version; TLFB total score; Sobell and Sobell, 1992; Mapi Institute, 2012).
Measured: 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)
Medical certified device of urinary drug testing measure of cocaine use in the last 7 days (Universitary Hospital Center of Martinique CSAPA, 2023).
Measured: 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
Self reported questionnaire measure of emotion dysregulation according to the Difficulties in Emotion Regulation Scale (french version; DERS total score; Côté et al., 2013).
Measured: 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)
Client Satisfaction related to the Therapy
Self reported questionnaire measure of client satisfaction related to the therapy according to the Client Satisfaction Questionnaire 8 (french version; CSQ 8 total score; Sabourin and al., 1989; Attkisson, 2020).
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 2023May 2025

First posted27 Apr 2023
Study start1 May 2023
Primary completionMay 2025 (estimated)
Study completionMay 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05833529
Sponsor's protocol ID: 22_RIPH2-18
Other IDs: 2022-A02440-43
Acronym: PICOC
Status last verified: Jun 2024
First submitted: 27 Mar 2023
Last updated: 10 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 11860387
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.
PubMed 12855083
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.
PubMed 29478874
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.
PubMed 25368571
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.
PubMed 16516397
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.
PubMed 38937824

Want to know more?

Thomas LEHOUX, Ph.D. Candidate

06 66 33 78 41 ext. +33

thomas.lehoux@hotmail.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cocaine Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05833529
Acronym / sponsor ID: PICOC / 22_RIPH2-18
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
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 54 participants (estimated)
Lead sponsor: Thomas LehouxUniversity, hospital or other
Collaborators: Laboratoire de Psychologie des Cognitions (Strasbourg University, France), ICube Laboratory - Team IGG (Strasbourg University, France), Hospital Center of Saint-Esprit (Martinique), National Cancer Institute, France, French Institute for Public Health Research (IReSP), GIRCI SOHO
Study start: 1 May 2023 (actual)
Primary completion: May 2025 (estimated)
Study completion: May 2025 (estimated)
First posted: 27 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VRCET for Cocaine Craving then MFCT	Experimental	Behavioral: Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks, Other: Memory Focused Cognitive Therapy (MFCT) - 1 week3 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.
PCET for Cocaine Craving	Active comparator	Behavioral: Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks3 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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,

Key exclusion criteria (10 listed)

Present the diagnostic criteria (MINI 5.0.0.; DSM-IV):
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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks40 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.	Behavioural	VRCET for Cocaine Craving then MFCT
Memory Focused Cognitive Therapy (MFCT) - 1 weekIn 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).	Other	VRCET for Cocaine Craving then MFCT
Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks60 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.	Behavioural	PCET for Cocaine Craving

Primary outcome

Change from Baseline Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving) at the End of Treatment
Time frame: 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.
Change from Baseline Cocaine Craving Frequency (Last 14 Days) at the End of Treatment
Time frame: 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.

15 secondary outcomes

Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Right before treatment; 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)
Time frame: 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)
Time frame: 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
Time frame: Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced
Ecological Validity related to Cue Exposure Environments for Cocaine Craving
Time frame: Before treatment; during treatment phase at each new cue exposure situation for cocaine craving experienced
Propensity to Cocaine Relapse (Next 2 Months)
Time frame: 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)
Dysfonctional Beliefs related to Cocaine Use
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Client Satisfaction related to the Therapy
Time frame: 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)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Background: PubMed 11860387Conklin 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.
Background: PubMed 12855083Lee 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.
Background: PubMed 29478874Marsden 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.
Background: PubMed 25368571Hone-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.
Background: PubMed 16516397Saladin 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.
Derived from this study: PubMed 38937824Lehoux 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas LEHOUX, Ph.D. Candidate contact

06 66 33 78 41 ext. +33

thomas.lehoux@hotmail.fr

Jérôme LACOSTE, MD contact

05 96 59 25 72 ext. +596

jérôme.lacoste@chu-martinique.fr

Jérôme LACOSTE, MD principal investigator

CHU of Martinique

Thomas LEHOUX, Ph.D. Candidate study director

Laboratoire de Psychologie des Cognitions (Strasbourg University, France)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas LEHOUX, Ph.D. Candidate (06 66 33 78 41 ext. +33, thomas.lehoux@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving) at the End of Treatment (time frame: Right before treatment and at the end of "VRCET then MFCT" and "PCET" (end of treatment; week 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05833529, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.