NCT04280900

Brief Summary

Cocaine addiction is a multifactorial disease with important consequences: somatic, psychiatric... The number of applications for treatment for cocaine addiction is gradually increasing from year to year but no conventional treatment is available. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations described by patients. We will then assess the effect of this cybertherapy on patients' relapse time and their desire to use cocaine

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

February 18, 2020

Last Update Submit

February 20, 2020

Conditions

AddictionCocaine-Related Disorders

Keywords

Cocaine-Related DisordersVirtual Reality Exposure TherapyBehavior Therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of relapser patients at 3 months post-intervention

    recovery in consumption of cocaine at M3 after intervention

    day 90 after intervention

Secondary Outcomes (21)

  • Craving score

    day 30 after intervention

  • Craving score

    day 90 after intervention

  • Score on the personal efficiency sentiment scale

    day 30 after intervention

  • Score on the personal efficiency sentiment scale

    day 90 after intervention

  • Consumption of quantity of cocaine

    day 30 after intervention

  • +16 more secondary outcomes

Study Arms (2)

cybertherapy

EXPERIMENTAL

use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)

Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)Behavioral: Treatment as usual

Treatment as usual

OTHER

Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)

Behavioral: Treatment as usual

Interventions

Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)BEHAVIORAL

use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)

cybertherapy
Treatment as usualBEHAVIORAL

Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)

Treatment as usualcybertherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suffering from a cocaine use disorder with craving criteria present according to the criteria of DSM 5
  • wanting to stop cocaine use
  • able to give informed consent to participate in research
  • Covered by a Social Security plan.

You may not qualify if:

  • Patient with:
  • psychiatric comorbidities (DSM 5) unstabilized
  • dipsomaniac alcoholism
  • an anteriority of one or more hypomanic or manic episodes
  • unstabilized psychosis
  • an unstabilized depression
  • a severe suicidal risk
  • a syndrome of dependence on products other than cocaine or tobacco
  • unstabilized anxiety
  • problems that hinder participation in 3D exposure, as a tendency to dissociation; phobias of the type of information (panic attacks and hypochondria...) severe dizziness...
  • cognitive problems limiting or preventing the possibility of implementing coping or managing emotions or stimuli and disabilities to complete questionnaires
  • a language barrier
  • a serious intercurrent pathology
  • the need for weekly individual follow-up Patient in a protected population such as pregnant women, lactating women, patients under guardianship, guardianship, deprived of freedoms, or in safeguarding justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont Ferrand

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Conditions

Behavior, AddictiveCocaine-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Georges Brousse

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 21, 2020

Study Start

June 1, 2020

Primary Completion

September 1, 2021

Study Completion

December 31, 2021

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

FR(1)