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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05557149
Acronym
RVCOC
Enrollment
11
Registered
2022-09-27
Start date
2021-03-31
Completion date
2021-07-29
Last updated
2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Use Disorder, Virtual Reality Exposure Therapy

Keywords

Virtual Reality, Cocaine Craving, Cue Exposure Therapy

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).

Interventions

DEVICEVirtual 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.

BEHAVIORALRespiratory Relaxation

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

DEVICEVirtual 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.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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., 2020)

Design outcomes

Primary

MeasureTime frameDescription
Cocaine Craving IntensityImmediatly 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

MeasureTime frameDescription
Self-Efficacy to Cope with Cocaine Craving without UsingImmediatly 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).
Negative Emotional StatesImmediatly 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).
Positive Emotional StatesImmediatly 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026