Virtual Reality Exposure and Respiratory Relaxation-Based Coping With Cocaine Craving in Cocaine Users

Study Overview
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Brief Summary
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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).

Official Title
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Development and Evaluation of a Virtual Reality Application for Eliciting Craving and Its Physiological Arousal in Cocaine Users

Conditions
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Virtual Reality Exposure Therapy, Cocaine Use Disorder

Intervention / Treatment
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* Device: Virtual Reality Exposure to Neutral Cues
* Behavioral: Respiratory Relaxation
* Device: Virtual Reality Exposure to Cocaine-Related Cues


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Cocaine use within the past 28 days Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Neutral VR<br>Ten minutes virtual reality exposure to neutral stimuli (e.g. neutral picture frames) | Device: Virtual Reality Exposure to Neutral Cues<br>* 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.<br>|
| Experimental: Cocaine VR<br>Ten minutes virtual reality exposure to cocaine use-related stimuli (i.e. peers using cocaine, cocaine paraphernalia, cocaine use preparing, cocaine use, etc.) | Device: Virtual Reality Exposure to Cocaine-Related Cues<br>* 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.<br>|
| Other: Relaxation<br>Ten minutes respiratory relaxation (eyes closed and sitted on a chair) | Behavioral: Respiratory Relaxation<br>* Respiratory relaxation practise. No interaction with the investigator during the relaxation practise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Cocaine Craving, Cue Exposure Therapy