Clinical trial NCT04280900: Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders
Official title: Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction
Cocaine-Related Disorders
Keywords: Cocaine-Related Disorders
Virtual Reality Exposure Therapy
Behavior Therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir, France
First posted: 2020-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Percentage of relapser patients at 3 months post-intervention
timeFrame: day 90 after intervention
Secondary outcomes:
measure: Craving score
timeFrame: day 30 after intervention
measure: Craving score
timeFrame: day 90 after intervention
measure: Score on the personal efficiency sentiment scale
timeFrame: day 30 after intervention
measure: Score on the personal efficiency sentiment scale
timeFrame: day 90 after intervention
measure: Consumption of quantity of cocaine
timeFrame: day 30 after intervention
measure: Consumption of quantity of cocaine
timeFrame: day 60 after intervention
measure: Consumption of quantity of cocaine
timeFrame: day 90 after intervention
measure: Frequency of consumption of cocaine
timeFrame: day 30 after intervention
measure: Frequency of consumption of cocaine
timeFrame: day 60 after intervention
measure: Frequency of consumption of cocaine
timeFrame: day 90 after intervention
measure: Way of consumption of cocaine
timeFrame: day 30 after intervention
measure: Way of consumption of cocaine
timeFrame: day 60 after intervention
measure: Way of consumption of cocaine
timeFrame: day 90 after intervention
measure: amount of cocaine consumed during relapse
timeFrame: day 30 after intervention
measure: amount of cocaine consumed during relapse
timeFrame: day 90 after intervention
measure: Frequence of cocaine consumed during relapse
timeFrame: day 30 after intervention
measure: Frequence of cocaine consumed during relapse
timeFrame: day 90 after intervention
measure: Percentage of relapser patients
timeFrame: day 30 after intervention
measure: Duration of abstinence
timeFrame: day 30 after intervention
measure: Duration of abstinence
timeFrame: day 60 after intervention
measure: Duration of abstinence
timeFrame: day 90 after intervention
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Georges Brousse
role: PRINCIPAL_INVESTIGATOR
References: