Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder (PICOC)

Thomas Lehoux

Status: Enrolling

Conditions: Cocaine Use Disorder

Treatments: Behavioral: Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks; Behavioral: Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks; Other: Memory Focused Cognitive Therapy (MFCT) - 1 week

Study type: Interventional

Funder types: Other

Identifiers

NCT05833529

2022-A02440-43 (Registry Identifier)

22_RIPH2-18

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

VRCET for Cocaine Craving then MFCT

Experimental group

Description:

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.

Treatment:

Other: Memory Focused Cognitive Therapy (MFCT) - 1 week

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

PCET for Cocaine Craving

Active Comparator group

Description:

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.

Treatment:

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