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

Not Applicable

Completed

• Conditions: Virtual Reality Exposure Therapy; Cocaine Use Disorder
• Interventions: Behavioral: Respiratory Relaxation; Device: Virtual Reality Exposure to Cocaine-Related Cues; Device: Virtual Reality Exposure to Neutral Cues

• Registration Number: NCT05557149
• Lead Sponsor: Laboratoire de Psychologie des Cognitions

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-31
• Primary Completion: 2021-07-29
• Study Completion: 2021-07-29
• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Relaxation	Respiratory Relaxation	Ten minutes respiratory relaxation (eyes closed and sitted on a chair)
Cocaine VR	Virtual Reality Exposure to Cocaine-Related Cues	Ten minutes virtual reality exposure to cocaine use-related stimuli (i.e. peers using cocaine, cocaine paraphernalia, cocaine use preparing, cocaine use, etc.)
Neutral VR	Virtual Reality Exposure to Neutral Cues	Ten minutes virtual reality exposure to neutral stimuli (e.g. neutral picture frames)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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).
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).

Trial Locations

Locations (1)

Laboratoire de Psychologie des Cognitions (Strasbourg University); 🇫🇷 Strasbourg, Bas-Rhin, France