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

Sponsor
Laboratoire de Psychologie des Cognitions (Other)
Overall Status
Completed
CT.gov ID
NCT05557149
Collaborator
ICube Laboratory - Team IGG (Other), Ithaque Association (Other), University Hospitals of Strasbourg (Other), University Hospital, Strasbourg, France (Other), The French National Cancer Institute (Other), The French Institute for Public Health Research (Other)
11
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3
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2.8

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Exposure to Neutral Cues
  • Behavioral: Respiratory Relaxation
  • Device: Virtual Reality Exposure to Cocaine-Related Cues
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Development and Evaluation of a Virtual Reality Application for Eliciting Craving and Its Physiological Arousal in Cocaine Users
Actual Study Start Date :
Mar 31, 2021
Actual Primary Completion Date :
Jul 29, 2021
Actual Study Completion Date :
Jul 29, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cocaine Craving Intensity [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).

Secondary Outcome Measures

  1. Self-Efficacy to Cope with Cocaine Craving without Using [Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)]

    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).

  2. Negative Emotional States [Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)]

    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).

  3. Positive Emotional States [Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratoire de Psychologie des Cognitions (Strasbourg University) Strasbourg Bas-Rhin France 67000

Sponsors and Collaborators

  • Laboratoire de Psychologie des Cognitions
  • ICube Laboratory - Team IGG
  • Ithaque Association
  • University Hospitals of Strasbourg
  • University Hospital, Strasbourg, France
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Lehoux, Ph.D. Candidate, Laboratoire de Psychologie des Cognitions
ClinicalTrials.gov Identifier:
NCT05557149
Other Study ID Numbers:
  • RVCOC2021
  • AAC21-SPA-04
  • 2021-A00242-39
  • 21.02.14.82513
First Posted:
Sep 27, 2022
Last Update Posted:
Sep 27, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thomas Lehoux, Ph.D. Candidate, Laboratoire de Psychologie des Cognitions
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2022