An interventional study of Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) and Treatment as usual in Addiction and Cocaine-Related Disorders, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment
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
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
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient with:
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) · Behavioral: Treatment as usual
Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)
Behavioral: Treatment as usual
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)
Percentage of relapser patients at 3 months post-intervention
recovery in consumption of cocaine at M3 after intervention
Time frame: day 90 after intervention
Craving score
evaluation of craving score (/10) compared to inclusion score
Time frame: day 30 after intervention
Craving score
evaluation of craving score (/10) compared to inclusion score
Time frame: day 90 after intervention
Score on the personal efficiency sentiment scale
Evaluation of the score on the personal efficiency sentiment scale
Time frame: day 30 after intervention
Score on the personal efficiency sentiment scale
Evaluation of the score on the personal efficiency sentiment scale
Time frame: day 90 after intervention
Consumption of quantity of cocaine
Evaluation of quantity of cocaine consumed
Time frame: day 30 after intervention
Consumption of quantity of cocaine
Evaluation of quantity of cocaine consumed
Time frame: day 60 after intervention
Consumption of quantity of cocaine
Evaluation of quantity of cocaine consumed
Time frame: day 90 after intervention
Frequency of consumption of cocaine
Evaluation of the frequency of cocaine consumption
Time frame: day 30 after intervention
Frequency of consumption of cocaine
Evaluation of the frequency of cocaine consumption
Time frame: day 60 after intervention
Frequency of consumption of cocaine
Evaluation of the frequency of cocaine consumption
Time frame: day 90 after intervention
Way of consumption of cocaine
Evaluation of the way of cocaine consumption
Time frame: day 30 after intervention
Way of consumption of cocaine
Evaluation of the way of cocaine consumption
Time frame: day 60 after intervention
Way of consumption of cocaine
Evaluation of the way of cocaine consumption
Time frame: day 90 after intervention
amount of cocaine consumed during relapse
Evaluation of cocaine amount consumed during relapse
Time frame: day 30 after intervention
amount of cocaine consumed during relapse
Evaluation of cocaine amount consumed during relapse
Time frame: day 90 after intervention
Frequence of cocaine consumed during relapse
Evaluation of cocaine frequence consumption during relapse
Time frame: day 30 after intervention
Frequence of cocaine consumed during relapse
Evaluation of cocaine frequence consumption during relapse
Time frame: day 90 after intervention
Percentage of relapser patients
recovery in relapser patients at M1 after intervention
Time frame: day 30 after intervention
Duration of abstinence
recovery of abstinence duration
Time frame: day 30 after intervention
Duration of abstinence
recovery of abstinence duration
Time frame: day 60 after intervention
Duration of abstinence
recovery of abstinence duration
Time frame: day 90 after intervention
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University Hospital, Clermont-Ferrand