Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280900
Recruitment Status : Not yet recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Fondation de l'Avenir, France
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Addiction Cocaine-Related Disorders Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) Behavioral: Treatment as usual Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of relapser patients at 3 months post-intervention [ Time Frame: day 90 after intervention ]
    recovery in consumption of cocaine at M3 after intervention


Secondary Outcome Measures :
  1. Craving score [ Time Frame: day 30 after intervention ]
    evaluation of craving score (/10) compared to inclusion score

  2. Craving score [ Time Frame: day 90 after intervention ]
    evaluation of craving score (/10) compared to inclusion score

  3. Score on the personal efficiency sentiment scale [ Time Frame: day 30 after intervention ]
    Evaluation of the score on the personal efficiency sentiment scale

  4. Score on the personal efficiency sentiment scale [ Time Frame: day 90 after intervention ]
    Evaluation of the score on the personal efficiency sentiment scale

  5. Consumption of quantity of cocaine [ Time Frame: day 30 after intervention ]
    Evaluation of quantity of cocaine consumed

  6. Consumption of quantity of cocaine [ Time Frame: day 60 after intervention ]
    Evaluation of quantity of cocaine consumed

  7. Consumption of quantity of cocaine [ Time Frame: day 90 after intervention ]
    Evaluation of quantity of cocaine consumed

  8. Frequency of consumption of cocaine [ Time Frame: day 30 after intervention ]
    Evaluation of the frequency of cocaine consumption

  9. Frequency of consumption of cocaine [ Time Frame: day 60 after intervention ]
    Evaluation of the frequency of cocaine consumption

  10. Frequency of consumption of cocaine [ Time Frame: day 90 after intervention ]
    Evaluation of the frequency of cocaine consumption

  11. Way of consumption of cocaine [ Time Frame: day 30 after intervention ]
    Evaluation of the way of cocaine consumption

  12. Way of consumption of cocaine [ Time Frame: day 60 after intervention ]
    Evaluation of the way of cocaine consumption

  13. Way of consumption of cocaine [ Time Frame: day 90 after intervention ]
    Evaluation of the way of cocaine consumption

  14. amount of cocaine consumed during relapse [ Time Frame: day 30 after intervention ]
    Evaluation of cocaine amount consumed during relapse

  15. amount of cocaine consumed during relapse [ Time Frame: day 90 after intervention ]
    Evaluation of cocaine amount consumed during relapse

  16. Frequence of cocaine consumed during relapse [ Time Frame: day 30 after intervention ]
    Evaluation of cocaine frequence consumption during relapse

  17. Frequence of cocaine consumed during relapse [ Time Frame: day 90 after intervention ]
    Evaluation of cocaine frequence consumption during relapse

  18. Percentage of relapser patients [ Time Frame: day 30 after intervention ]
    recovery in relapser patients at M1 after intervention

  19. Duration of abstinence [ Time Frame: day 30 after intervention ]
    recovery of abstinence duration

  20. Duration of abstinence [ Time Frame: day 60 after intervention ]
    recovery of abstinence duration

  21. Duration of abstinence [ Time Frame: day 90 after intervention ]
    recovery of abstinence duration


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280900


Contacts
Layout table for location contacts
Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU Clermont Ferrand
Clermont-Ferrand, Auvergne, France, 63000
Contact: Lise Laclautre    0473754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Georges Brousse         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fondation de l'Avenir, France
Investigators
Layout table for investigator information
Principal Investigator: Georges Brousse University Hospital, Clermont-Ferrand
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04280900    
Other Study ID Numbers: RBHP 2019 BROUSSE
2019-A02368-49 ( Other Identifier: 2019-A02368-49 )
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Cocaine-Related Disorders
Virtual Reality Exposure Therapy
Behavior Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Cocaine-Related Disorders
Pathologic Processes
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders