Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders (CORVI)

Cocaine addiction is a multifactorial disease with important consequences: somatic, psychiatric... The number of applications for treatment for cocaine addiction is gradually increasing from year to year but no conventional treatment is available. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations described by patients. We will then assess the effect of this cybertherapy on patients' relapse time and their desire to use cocaine

Study Overview

• Status: Unknown
• Conditions: Addiction; Cocaine-Related Disorders
• Intervention / Treatment: Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT); Behavioral: Treatment as usual

Detailed Description

In France, according to the Health Barometer 2017, cocaine testing has seen two decades of increases from 1.2% in 1995 to 5.6% in 2017, making it the second most widely used illicit substance. About 5% of cocaine users may become addicted in the first year of use, while 20% will develop long-term addiction. This dependence or substance use disorder is characterized in particular by a loss of control of cocaine use and continued use despite the negative consequences. Another of the central dimensions of this disorder is the craving (irresistible or irrepressible need or desire to consume) which is caused by internal or external stimuli. Craving is the cause of frequent loss of controls and re-consumption.

The treatment of cocaine addictions is generally based on a dual model of pharmacological treatment often aimed at limiting craving and psychotherapeutic treatment in order to alter the emotions and memory associated with cocaine use; for example: relearning product management when it comes to the subject.

In this context, the use of a 3D tool, which allows a gradual and well-detested exposure without confrontation, seems an interesting prospect. Virtual reality therapies have historically been known for treating phobias (fears). In addictions, exposure therapies are done in imagination and rarely with consumer-inducing situations. Since 2000, several researchers have successfully used virtual reality applications in addictions, but there is little data on objective assessments of the effectiveness of cybertherapy in the treatment of cocaine addictions.

All of these elements converge to propose a protocol called "CORVI" to evaluate the effectiveness of virtual reality exposure therapy as the management of patients with cocaine use disorder versus management classic.

The project is based on 3 phases: 1/construction of films that can be used in cybertherapy that reproduce situations in which there are stimuli generating "craving" to cocaine. 2/ Treatment of 2 randomized patient groups with and without cybertherapy (n-20/group) 3/Relapse evaluations at 1.2 and 3 months post-treatment

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63000
      • Chu Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• suffering from a cocaine use disorder with craving criteria present according to the criteria of DSM 5
• wanting to stop cocaine use
• able to give informed consent to participate in research
• Covered by a Social Security plan.

Exclusion Criteria:

Patient with:

• psychiatric comorbidities (DSM 5) unstabilized
• dipsomaniac alcoholism
• an anteriority of one or more hypomanic or manic episodes
• unstabilized psychosis
• an unstabilized depression
• a severe suicidal risk
• a syndrome of dependence on products other than cocaine or tobacco
• unstabilized anxiety
• problems that hinder participation in 3D exposure, as a tendency to dissociation; phobias of the type of information (panic attacks and hypochondria...) severe dizziness...
• cognitive problems limiting or preventing the possibility of implementing coping or managing emotions or stimuli and disabilities to complete questionnaires
• a language barrier
• a serious intercurrent pathology
• the need for weekly individual follow-up Patient in a protected population such as pregnant women, lactating women, patients under guardianship, guardianship, deprived of freedoms, or in safeguarding justice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: cybertherapy; use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)	Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT); use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified); Behavioral: Treatment as usual; Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)
OTHER: Treatment as usual; Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)	Behavioral: Treatment as usual; Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of relapser patients at 3 months post-intervention	recovery in consumption of cocaine at M3 after intervention	day 90 after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving score	evaluation of craving score (/10) compared to inclusion score	day 30 after intervention
Craving score	evaluation of craving score (/10) compared to inclusion score	day 90 after intervention
Score on the personal efficiency sentiment scale	Evaluation of the score on the personal efficiency sentiment scale	day 30 after intervention
Score on the personal efficiency sentiment scale	Evaluation of the score on the personal efficiency sentiment scale	day 90 after intervention
Consumption of quantity of cocaine	Evaluation of quantity of cocaine consumed	day 30 after intervention
Consumption of quantity of cocaine	Evaluation of quantity of cocaine consumed	day 60 after intervention
Consumption of quantity of cocaine	Evaluation of quantity of cocaine consumed	day 90 after intervention
Frequency of consumption of cocaine	Evaluation of the frequency of cocaine consumption	day 30 after intervention
Frequency of consumption of cocaine	Evaluation of the frequency of cocaine consumption	day 60 after intervention
Frequency of consumption of cocaine	Evaluation of the frequency of cocaine consumption	day 90 after intervention
Way of consumption of cocaine	Evaluation of the way of cocaine consumption	day 30 after intervention
Way of consumption of cocaine	Evaluation of the way of cocaine consumption	day 60 after intervention
Way of consumption of cocaine	Evaluation of the way of cocaine consumption	day 90 after intervention
amount of cocaine consumed during relapse	Evaluation of cocaine amount consumed during relapse	day 30 after intervention
amount of cocaine consumed during relapse	Evaluation of cocaine amount consumed during relapse	day 90 after intervention
Frequence of cocaine consumed during relapse	Evaluation of cocaine frequence consumption during relapse	day 30 after intervention
Frequence of cocaine consumed during relapse	Evaluation of cocaine frequence consumption during relapse	day 90 after intervention
Percentage of relapser patients	recovery in relapser patients at M1 after intervention	day 30 after intervention
Duration of abstinence	recovery of abstinence duration	day 30 after intervention
Duration of abstinence	recovery of abstinence duration	day 60 after intervention
Duration of abstinence	recovery of abstinence duration	day 90 after intervention

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Fondation de l'Avenir, France
• Investigators: Principal Investigator: Georges Brousse, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (ACTUAL): February 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Behavior Therapy; Virtual Reality Exposure Therapy; Cocaine-Related Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Cocaine-Related Disorders
• Other Study ID Numbers: RBHP 2019 BROUSSE; 2019-A02368-49 (OTHER: 2019-A02368-49)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No