NCT05557149

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

September 19, 2022

Last Update Submit

September 22, 2022

Conditions

Virtual Reality Exposure TherapyCocaine Use Disorder

Keywords

Virtual RealityCocaine CravingCue Exposure Therapy

Outcome Measures

Primary Outcomes (1)

  • Cocaine Craving Intensity

    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).

    Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)

Secondary Outcomes (3)

  • Self-Efficacy to Cope with Cocaine Craving without Using

    Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)

  • Negative Emotional States

    Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)

  • Positive Emotional States

    Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)

Study Arms (3)

Neutral VR

SHAM COMPARATOR

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

Device: Virtual Reality Exposure to Neutral Cues

Cocaine VR

EXPERIMENTAL

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

Relaxation

OTHER

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

Behavioral: Respiratory Relaxation

Interventions

Virtual Reality Exposure to Neutral CuesDEVICE

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.

Neutral VR
Respiratory RelaxationBEHAVIORAL

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

Relaxation
Virtual Reality Exposure to Cocaine-Related CuesDEVICE

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.

Cocaine VR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Cocaine use within the past 28 days

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire de Psychologie des Cognitions (Strasbourg University)

Strasbourg, Bas-Rhin, 67000, France

Location

Study Officials

  • Thomas Lehoux, Ph.D. Candidate

    Laboratoire de Psychologie des Cognitions (Strasbourg University)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Candidate

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 27, 2022

Study Start

March 31, 2021

Primary Completion

July 29, 2021

Study Completion

July 29, 2021

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)