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

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).

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder; Virtual Reality Exposure Therapy
• Intervention / Treatment: Device: Virtual Reality Exposure to Neutral Cues; Device: Virtual Reality Exposure to Cocaine-Related Cues; Behavioral: Respiratory Relaxation

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67000
      • Laboratoire de Psychologie des Cognitions (Strasbourg University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Neutral VR; Ten minutes virtual reality exposure to neutral stimuli (e.g. neutral picture frames)	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.
Experimental: Cocaine VR; 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; 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.
Other: Relaxation; Ten minutes respiratory relaxation (eyes closed and sitted on a chair)	Behavioral: Respiratory Relaxation; Respiratory relaxation practise. No interaction with the investigator during the relaxation practise.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Laboratoire de Psychologie des Cognitions
• Collaborators: University Hospital, Strasbourg, France; ICube Laboratory - Team IGG; Ithaque Association; University Hospitals of Strasbourg; The French National Cancer Institute; The French Institute for Public Health Research
• Investigators: Principal Investigator: Thomas Lehoux, Ph.D. Candidate, Laboratoire de Psychologie des Cognitions (Strasbourg University)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): July 29, 2021

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Cocaine Craving; Cue Exposure Therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Dopamine Uptake Inhibitors; Vasoconstrictor Agents; Cocaine
• Other Study ID Numbers: RVCOC2021; AAC21-SPA-04 (Other Grant/Funding Number: The French Institute for Public Health Research & The French National Cancer Institute); 2021-A00242-39 (Other Identifier: French Agency for the Safety of Health Products (ANSM)); 21.02.14.82513 (Other Identifier: Research Ethic Committee (CPP) - Sud Méditerranée V)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No