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

Primary Purpose

Addiction, Cocaine-Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)
Treatment as usual
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring Cocaine-Related Disorders, Virtual Reality Exposure Therapy, Behavior Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

cybertherapy

Treatment as usual

Arm Description

use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)

Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)

Outcomes

Primary Outcome Measures

Percentage of relapser patients at 3 months post-intervention
recovery in consumption of cocaine at M3 after intervention

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2020
Last Updated
February 20, 2020
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation de l'Avenir, France
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1. Study Identification

Unique Protocol Identification Number
NCT04280900
Brief Title
Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders
Acronym
CORVI
Official Title
Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation de l'Avenir, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Cocaine-Related Disorders
Keywords
Cocaine-Related Disorders, Virtual Reality Exposure Therapy, Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cybertherapy
Arm Type
Experimental
Arm Description
use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)
Intervention Description
use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)
Primary Outcome Measure Information:
Title
Percentage of relapser patients at 3 months post-intervention
Description
recovery in consumption of cocaine at M3 after intervention
Time Frame
day 90 after intervention
Secondary Outcome Measure Information:
Title
Craving score
Description
evaluation of craving score (/10) compared to inclusion score
Time Frame
day 30 after intervention
Title
Craving score
Description
evaluation of craving score (/10) compared to inclusion score
Time Frame
day 90 after intervention
Title
Score on the personal efficiency sentiment scale
Description
Evaluation of the score on the personal efficiency sentiment scale
Time Frame
day 30 after intervention
Title
Score on the personal efficiency sentiment scale
Description
Evaluation of the score on the personal efficiency sentiment scale
Time Frame
day 90 after intervention
Title
Consumption of quantity of cocaine
Description
Evaluation of quantity of cocaine consumed
Time Frame
day 30 after intervention
Title
Consumption of quantity of cocaine
Description
Evaluation of quantity of cocaine consumed
Time Frame
day 60 after intervention
Title
Consumption of quantity of cocaine
Description
Evaluation of quantity of cocaine consumed
Time Frame
day 90 after intervention
Title
Frequency of consumption of cocaine
Description
Evaluation of the frequency of cocaine consumption
Time Frame
day 30 after intervention
Title
Frequency of consumption of cocaine
Description
Evaluation of the frequency of cocaine consumption
Time Frame
day 60 after intervention
Title
Frequency of consumption of cocaine
Description
Evaluation of the frequency of cocaine consumption
Time Frame
day 90 after intervention
Title
Way of consumption of cocaine
Description
Evaluation of the way of cocaine consumption
Time Frame
day 30 after intervention
Title
Way of consumption of cocaine
Description
Evaluation of the way of cocaine consumption
Time Frame
day 60 after intervention
Title
Way of consumption of cocaine
Description
Evaluation of the way of cocaine consumption
Time Frame
day 90 after intervention
Title
amount of cocaine consumed during relapse
Description
Evaluation of cocaine amount consumed during relapse
Time Frame
day 30 after intervention
Title
amount of cocaine consumed during relapse
Description
Evaluation of cocaine amount consumed during relapse
Time Frame
day 90 after intervention
Title
Frequence of cocaine consumed during relapse
Description
Evaluation of cocaine frequence consumption during relapse
Time Frame
day 30 after intervention
Title
Frequence of cocaine consumed during relapse
Description
Evaluation of cocaine frequence consumption during relapse
Time Frame
day 90 after intervention
Title
Percentage of relapser patients
Description
recovery in relapser patients at M1 after intervention
Time Frame
day 30 after intervention
Title
Duration of abstinence
Description
recovery of abstinence duration
Time Frame
day 30 after intervention
Title
Duration of abstinence
Description
recovery of abstinence duration
Time Frame
day 60 after intervention
Title
Duration of abstinence
Description
recovery of abstinence duration
Time Frame
day 90 after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Brousse
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
0473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Georges Brousse

12. IPD Sharing Statement

Learn more about this trial

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

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