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

NCT ID: NCT05557149

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-07-29

Brief Summary

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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

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Conditions

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Virtual Reality Exposure Therapy Cocaine Use Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Neutral VR

Ten minutes virtual reality exposure to neutral stimuli (e.g. neutral picture frames)

Group Type SHAM_COMPARATOR

Virtual Reality Exposure to Neutral Cues

Intervention Type 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.

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.)

Group Type EXPERIMENTAL

Virtual Reality Exposure to Cocaine-Related Cues

Intervention Type 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.

Relaxation

Ten minutes respiratory relaxation (eyes closed and sitted on a chair)

Group Type OTHER

Respiratory Relaxation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DEVICE

Respiratory Relaxation

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

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICube Laboratory - Team IGG

UNKNOWN

Sponsor Role collaborator

Ithaque Association

UNKNOWN

Sponsor Role collaborator

University Hospitals of Strasbourg

UNKNOWN

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

The French National Cancer Institute

UNKNOWN

Sponsor Role collaborator

The French Institute for Public Health Research

UNKNOWN

Sponsor Role collaborator

Laboratoire de Psychologie des Cognitions

OTHER

Sponsor Role lead

Responsible Party

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Thomas Lehoux

Ph.D. Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Lehoux, Ph.D. Candidate

Role: PRINCIPAL_INVESTIGATOR

Laboratoire de Psychologie des Cognitions (Strasbourg University)

Locations

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Laboratoire de Psychologie des Cognitions (Strasbourg University)

Strasbourg, Bas-Rhin, France

Site Status

Countries

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France

Other Identifiers

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AAC21-SPA-04

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-A00242-39

Identifier Type: OTHER

Identifier Source: secondary_id

21.02.14.82513

Identifier Type: OTHER

Identifier Source: secondary_id

RVCOC2021

Identifier Type: -

Identifier Source: org_study_id

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