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

Cocaine Use Disorder Clinical Trial

— RVCOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05557149
• Other study ID #: RVCOC2021
• Secondary ID: AAC21-SPA-042021
• Status: Completed
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: July 29, 2021

Study information

• Verified date: September 2022
• Source: Laboratoire de Psychologie des Cognitions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 29, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Virtual Reality Exposure Therapy

Intervention

Device:
• Virtual Reality Exposure to Neutral Cues
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.

Behavioral:
• Respiratory Relaxation
Respiratory relaxation practise. No interaction with the investigator during the relaxation practise.

Device:
• Virtual Reality Exposure to Cocaine-Related Cues
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.

Locations

Country	Name	City	State
France	Laboratoire de Psychologie des Cognitions (Strasbourg University)	Strasbourg	Bas-Rhin

Sponsors (7)

Lead Sponsor	Collaborator
Laboratoire de Psychologie des Cognitions	ICube Laboratory - Team IGG, Ithaque Association, The French Institute for Public Health Research, The French National Cancer Institute, University Hospital, Strasbourg, France, University Hospitals of Strasbourg

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)