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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05557149
Other study ID # RVCOC2021
Secondary ID AAC21-SPA-042021
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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