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Completed

NCT Number: NCT05557149

Virtual Reality Exposure and Respiratory Relaxation-Based Coping With Cocaine Craving 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).

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Key information

Conditions

Virtual Reality Exposure Therapy Cocaine Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratoire de Psychologie des Cognitions (Strasbourg University)

Strasbourg, Bas-Rhin, 67000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual Reality Exposure to Neutral Cues

Device

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.

Respiratory Relaxation

Behavioral

Respiratory relaxation practise. No interaction with the investigator during the relaxation practise.

Virtual Reality Exposure to Cocaine-Related Cues

Device

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.

Primary outcomes

  1. Cocaine Craving Intensity

    Time frame: 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 outcomes

  1. Self-Efficacy to Cope with Cocaine Craving without Using

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Laboratoire de Psychologie des Cognitions

Other

Collaborators

  • ICube Laboratory - Team IGG
  • Ithaque Association
  • National Cancer Institute, France
  • The French Institute for Public Health Research
  • University Hospital, Strasbourg, France
  • University Hospitals of Strasbourg

Registry information

Official study title

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

Acronym: RVCOC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2022
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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