AddictionCORVINCT04280900
Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders
A study testing Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) and Treatment as usual in people with Addiction and Cocaine-Related Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Addiction, Cocaine-Related Disorders
- What is being tested?
- Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient with:
- psychiatric comorbidities (DSM 5) unstabilized
- dipsomaniac alcoholism
- an anteriority of one or more hypomanic or manic episodes
- unstabilized psychosis
- an unstabilized depression
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont Ferrand
Clermont-Ferrand, Auvergne, 63000
Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Georges Brousse
About this study
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
Read the 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
- Conditions
- Addiction, Cocaine-Related Disorders
- Being tested
- Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT), Treatment as usual
- Keywords
- Cocaine-Related Disorders, Virtual Reality Exposure Therapy, Behavior Therapy
- Medical subject headings
- Behavior, Addictive, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)Behavioural
use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)
Treatment as usualBehavioural
Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)
| Study group | Role | What they receive |
|---|---|---|
| cybertherapy | Experimental | use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified) Receives: Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT); Behavioral: Treatment as usual |
| Treatment as usual | Other | Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified) Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of relapser patients at 3 months post-intervention
recovery in consumption of cocaine at M3 after intervention
Measured: day 90 after intervention
Secondary outcomes (21)
Craving score
evaluation of craving score (/10) compared to inclusion score
Measured: day 30 after intervention
Craving score
evaluation of craving score (/10) compared to inclusion score
Measured: day 90 after intervention
Score on the personal efficiency sentiment scale
Evaluation of the score on the personal efficiency sentiment scale
Measured: day 30 after intervention
Score on the personal efficiency sentiment scale
Evaluation of the score on the personal efficiency sentiment scale
Measured: day 90 after intervention
Consumption of quantity of cocaine
Evaluation of quantity of cocaine consumed
Measured: day 30 after intervention
Consumption of quantity of cocaine
Evaluation of quantity of cocaine consumed
Measured: day 60 after intervention
Consumption of quantity of cocaine
Evaluation of quantity of cocaine consumed
Measured: day 90 after intervention
Frequency of consumption of cocaine
Evaluation of the frequency of cocaine consumption
Measured: day 30 after intervention
Frequency of consumption of cocaine
Evaluation of the frequency of cocaine consumption
Measured: day 60 after intervention
Frequency of consumption of cocaine
Evaluation of the frequency of cocaine consumption
Measured: day 90 after intervention
Way of consumption of cocaine
Evaluation of the way of cocaine consumption
Measured: day 30 after intervention
Way of consumption of cocaine
Evaluation of the way of cocaine consumption
Measured: day 60 after intervention
Way of consumption of cocaine
Evaluation of the way of cocaine consumption
Measured: day 90 after intervention
amount of cocaine consumed during relapse
Evaluation of cocaine amount consumed during relapse
Measured: day 30 after intervention
amount of cocaine consumed during relapse
Evaluation of cocaine amount consumed during relapse
Measured: day 90 after intervention
Frequence of cocaine consumed during relapse
Evaluation of cocaine frequence consumption during relapse
Measured: day 30 after intervention
Frequence of cocaine consumed during relapse
Evaluation of cocaine frequence consumption during relapse
Measured: day 90 after intervention
Percentage of relapser patients
recovery in relapser patients at M1 after intervention
Measured: day 30 after intervention
Duration of abstinence
recovery of abstinence duration
Measured: day 30 after intervention
Duration of abstinence
recovery of abstinence duration
Measured: day 60 after intervention
Duration of abstinence
recovery of abstinence duration
Measured: day 90 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir, France
- Responsible party
- Sponsor
- Investigators
- Georges Brousse, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280900
- Sponsor's protocol ID
- RBHP 2019 BROUSSE
- Other IDs
- 2019-A02368-49
- Acronym
- CORVI
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders
- ClinicalTrials.gov ID
- NCT04280900
- Acronym / sponsor ID
- CORVI / RBHP 2019 BROUSSE
- Conditions
- Addiction, Cocaine-Related Disorders
- Keywords
- Cocaine-Related Disorders, Virtual Reality Exposure Therapy, Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir, France
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cybertherapy | Experimental | Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT), Behavioral: Treatment as usualuse of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified) |
| Treatment as usual | Other | Behavioral: Treatment as usualTreatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- psychiatric comorbidities (DSM 5) unstabilized
- dipsomaniac alcoholism
- an anteriority of one or more hypomanic or manic episodes
- unstabilized psychosis
- an unstabilized depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | cybertherapy |
| Treatment as usualTreatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified) | Behavioural | Treatment as usual, cybertherapy |
Primary outcome
Percentage of relapser patients at 3 months post-intervention
Time frame: day 90 after intervention
recovery in consumption of cocaine at M3 after intervention
21 secondary outcomes
Craving score
Time frame: day 30 after intervention
Craving score
Time frame: day 90 after intervention
Score on the personal efficiency sentiment scale
Time frame: day 30 after intervention
Score on the personal efficiency sentiment scale
Time frame: day 90 after intervention
Consumption of quantity of cocaine
Time frame: day 30 after intervention
Consumption of quantity of cocaine
Time frame: day 60 after intervention
Consumption of quantity of cocaine
Time frame: day 90 after intervention
Frequency of consumption of cocaine
Time frame: day 30 after intervention
Frequency of consumption of cocaine
Time frame: day 60 after intervention
Frequency of consumption of cocaine
Time frame: day 90 after intervention
Way of consumption of cocaine
Time frame: day 30 after intervention
Way of consumption of cocaine
Time frame: day 60 after intervention
Way of consumption of cocaine
Time frame: day 90 after intervention
amount of cocaine consumed during relapse
Time frame: day 30 after intervention
amount of cocaine consumed during relapse
Time frame: day 90 after intervention
Frequence of cocaine consumed during relapse
Time frame: day 30 after intervention
Frequence of cocaine consumed during relapse
Time frame: day 90 after intervention
Percentage of relapser patients
Time frame: day 30 after intervention
Duration of abstinence
Time frame: day 30 after intervention
Duration of abstinence
Time frame: day 60 after intervention
Duration of abstinence
Time frame: day 90 after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges Brousse principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) and Treatment as usual in people with Addiction and Cocaine-Related Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of relapser patients at 3 months post-intervention (time frame: day 90 after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.