Virtual Reality Exposure TherapyRVCOCNCT05557149
Virtual Reality Exposure and Respiratory Relaxation-Based Coping With Cocaine Craving in Cocaine Users
A study testing Virtual Reality Exposure to Neutral Cues, Respiratory Relaxation and Virtual Reality Exposure to Cocaine-Related Cues in people with Virtual Reality Exposure Therapy and Cocaine Use Disorder, run by Laboratoire de Psychologie des Cognitions at 1 site in France.
Trial summary
Our study main objective is to test whether virtual reality exposure could elicit cocaine craving and its physiological arousal in cocaine users. Investigators aim to compare self-reported cocaine craving, self-efficacy to cope with craving and emotional states levels in 11 voluntary and adults cocaine users in 3… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality Exposure Therapy, Cocaine Use Disorder
- What is being tested?
- Virtual Reality Exposure to Neutral Cues, Respiratory Relaxation and Virtual Reality Exposure to Cocaine-Related Cues
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to 29 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cocaine use within the past 28 days
Who cannot join
- Actual manic or hypomanic episode (MINI, Lecrubier and al., 1998)
- Actual psychotic episode (MINI, Lecrubier and al., 1998)
- Actual high suicidal risk (MINI, Lecrubier and al., 1998)
- Being involved in incarceration procedure
- Medical risk for safety while physiological arousal (e.g. cardiac disease)
- Disability for performing virtual reality task (e.g. blindness or deafness)
- Significant motion sickness symptoms (SSQ pre-post total score ≥ 15, Bimberg et al., 2020)
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire de Psychologie des Cognitions (Strasbourg University)
Strasbourg, Bas-Rhin, 67000
About this study
Official title: Development and Evaluation of a Virtual Reality Application for Eliciting Craving and Its Physiological Arousal in Cocaine Users
Our study main objective is to test whether virtual reality exposure could elicit cocaine craving and its physiological arousal in cocaine users. Investigators aim to compare self-reported cocaine craving, self-efficacy to cope with craving and emotional states levels in 11 voluntary and adults cocaine users in 3 consecutive 10-mins conditions: Neutral VR (virtual reality exposure to neutral stimuli), Cocaine VR (virtual reality exposure to cocaine use-related stimuli) and Relaxation (respiratory relaxation).
- Being tested
- Virtual Reality Exposure to Neutral Cues, Respiratory Relaxation, Virtual Reality Exposure to Cocaine-Related Cues
- Keywords
- Virtual Reality, Cocaine Craving, Cue Exposure Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure to Neutral CuesDevice
Virtual reality exposure to neutral stimuli (360 degrees visual and audio immersion with Oculus Quest 2 virtual reality headset). Participants stay sitted on chair and can tilt, rotate and move forward and backward upper body members. No interaction with the investigator during the virtual reality immersion.
Respiratory RelaxationBehavioural
Respiratory relaxation practise. No interaction with the investigator during the relaxation practise.
Virtual Reality Exposure to Cocaine-Related CuesDevice
Virtual reality exposure to cocaine-related stimuli (360 degrees visual and audio immersion with Oculus Quest 2 virtual reality headset). Participants stay sitted on chair and can tilt, rotate and move forward and backward upper body members. No interaction with the investigator during the virtual reality immersion.
| Study group | Role | What they receive |
|---|---|---|
| Neutral VR | Sham comparator | Ten minutes virtual reality exposure to neutral stimuli (e.g. neutral picture frames) Receives: Device: Virtual Reality Exposure to Neutral Cues |
| Cocaine VR | Experimental | Ten minutes virtual reality exposure to cocaine use-related stimuli (i.e. peers using cocaine, cocaine paraphernalia, cocaine use preparing, cocaine use, etc.) Receives: Device: Virtual Reality Exposure to Cocaine-Related Cues |
| Relaxation | Other | Ten minutes respiratory relaxation (eyes closed and sitted on a chair) Receives: Behavioral: Respiratory Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Craving Intensity
Change in self-reported cocaine craving intensity between 3 consecutive interventions: Neutral VR, Cocaine VR and Relaxation (CCQ-Brief total score, french version; Karila and al., 2011). CCQ-Brief total score varies from 10 to 70 (higher score suggesting higher craving intensity).
Measured: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Secondary outcomes (3)
Self-Efficacy to Cope with Cocaine Craving without Using
Change in self-reported efficacy level to cope with cocaine craving without using between 3 consecutive interventions: Neutral VR, Cocaine VR and Relaxation (DTCQ-8 total score, original version translated in french; Sklar and Turner, 1999). DTCQ-8 total score varies from 0 to 800 (higher score suggesting higher self-efficacy to cope with cocaine craving without using).
Measured: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Negative Emotional States
Change in negative emotional states level between 3 consecutive interventions: Neutral VR, Cocaine VR and Relaxation (BMIS negative emotional states total score, adapted version translated in french Mayer et al., 1988). BMIS negative emotional states total score varies from 0 to 21 (higher score suggesting higher negative emotional states).
Measured: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Positive Emotional States
Change in positive emotinal states level between 3 consecutive interventions: Neutral VR, Cocaine VR and Relaxation (BMIS positive emotional states total score, adapted version translated in french Mayer et al., 1988). BMIS positive emotional states total score varies from 0 to 9 (higher score suggesting higher positive emotional states).
Measured: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start31 Mar 2021
- Primary completion29 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual Reality Exposure TherapyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire de Psychologie des Cognitions
- Sponsor type
- University, hospital or other
- Collaborators
- ICube Laboratory - Team IGG, Ithaque Association, University Hospitals of Strasbourg, University Hospital, Strasbourg, France, National Cancer Institute, France, The French Institute for Public Health Research
- Responsible party
- Principal investigator, Thomas Lehoux, Laboratoire de Psychologie des Cognitions
- Investigators
- Thomas Lehoux, Ph.D. Candidate, Principal investigator, Laboratoire de Psychologie des Cognitions (Strasbourg University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557149
- Sponsor's protocol ID
- RVCOC2021
- Other IDs
- AAC21-SPA-04, 2021-A00242-39, 21.02.14.82513
- Acronym
- RVCOC
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Virtual Reality Application for Eliciting Craving and Its Physiological Arousal in Cocaine Users
- ClinicalTrials.gov ID
- NCT05557149
- Acronym / sponsor ID
- RVCOC / RVCOC2021
- Keywords
- Virtual Reality, Cocaine Craving, Cue Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Laboratoire de Psychologie des CognitionsUniversity, hospital or other
- Collaborators
- ICube Laboratory - Team IGG, Ithaque Association, University Hospitals of Strasbourg, University Hospital, Strasbourg, France, National Cancer Institute, France, The French Institute for Public Health Research
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 27 Sep 2022 (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.
Our study main objective is to test whether virtual reality exposure could elicit cocaine craving and its physiological arousal in cocaine users. Investigators aim to compare self-reported cocaine craving, self-efficacy to cope with craving and emotional states levels in 11 voluntary and adults cocaine users in 3 consecutive 10-mins conditions: Neutral VR (virtual reality exposure to neutral stimuli), Cocaine VR (virtual reality exposure to cocaine use-related stimuli) and Relaxation (respiratory relaxation).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutral VR | Sham comparator | Device: Virtual Reality Exposure to Neutral CuesTen minutes virtual reality exposure to neutral stimuli (e.g. neutral picture frames) |
| Cocaine VR | Experimental | Device: Virtual Reality Exposure to Cocaine-Related CuesTen minutes virtual reality exposure to cocaine use-related stimuli (i.e. peers using cocaine, cocaine paraphernalia, cocaine use preparing, cocaine use, etc.) |
| Relaxation | Other | Behavioral: Respiratory RelaxationTen minutes respiratory relaxation (eyes closed and sitted on a chair) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cocaine use within the past 28 days
Key exclusion criteria (7 listed)
- Actual manic or hypomanic episode (MINI, Lecrubier and al., 1998)
- Actual psychotic episode (MINI, Lecrubier and al., 1998)
- Actual high suicidal risk (MINI, Lecrubier and al., 1998)
- Being involved in incarceration procedure
- Medical risk for safety while physiological arousal (e.g. cardiac disease)
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 Exposure to Neutral CuesVirtual reality exposure to neutral stimuli (360 degrees visual and audio immersion with Oculus Quest 2 virtual reality headset). Participants stay sitted on chair and can tilt, rotate and move forward and backward upper body members. No interaction with the investigator during the virtual reality immersion. | Device | Neutral VR |
| Respiratory RelaxationRespiratory relaxation practise. No interaction with the investigator during the relaxation practise. | Behavioural | Relaxation |
| Virtual Reality Exposure to Cocaine-Related CuesVirtual reality exposure to cocaine-related stimuli (360 degrees visual and audio immersion with Oculus Quest 2 virtual reality headset). Participants stay sitted on chair and can tilt, rotate and move forward and backward upper body members. No interaction with the investigator during the virtual reality immersion. | Device | Cocaine VR |
Primary outcome
Cocaine Craving Intensity
Time frame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Change in self-reported cocaine craving intensity between 3 consecutive interventions: Neutral VR, Cocaine VR and Relaxation (CCQ-Brief total score, french version; Karila and al., 2011). CCQ-Brief total score varies from 10 to 70 (higher score suggesting higher craving intensity).
3 secondary outcomes
Self-Efficacy to Cope with Cocaine Craving without Using
Time frame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Negative Emotional States
Time frame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Positive Emotional States
Time frame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Thomas Lehoux, Ph.D. Candidate principal investigator
Laboratoire de Psychologie des Cognitions (Strasbourg University)
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 Exposure to Neutral Cues, Respiratory Relaxation and Virtual Reality Exposure to Cocaine-Related Cues in people with Virtual Reality Exposure Therapy and Cocaine Use Disorder, run by Laboratoire de Psychologie des Cognitions 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 27 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine Craving Intensity (time frame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)). 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 27 Sep 2022.