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Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation (VIREAMIND)

Primary Purpose

Tobacco Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality pod
nicotine patches and chewing gum
Sponsored by
Centre Hospitalier Henri Laborit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring relapse, craving

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Any patient consuming 10 to 40 cigarettes per day Woman or man aged 18 to 75 inclusive Substance use disorder according to the DSM5 classification Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person Having signed the informed consent form after having received written information. Exclusion Criteria: Disabling cognitive disorders Patient under 18 or over 75 years old. Patient with a psychological disorder or a psychiatric pathology requiring specialized follow-up Patient with addiction to another product. Cardiological pathologies that could compromise the participation of patients, detected by an ECG (only for patients who will be randomized in the experimental group). Advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor Pregnant or breastfeeding woman Simultaneous participation in another trial Employee of the investigator or of the clinical trial site Patients protected by law Patients who do not speak the French language People not covered by state health insurance Patients who in the opinion of the investigator are unable to complete the questionnaires Patient claustrophobic or anxious about using the cabin Patient allergic to a molecule present in nicotine substitutes

Sites / Locations

  • Cabinet MédicalRecruiting
  • Cabinet médical des CouronneriesRecruiting
  • Centre Hospitalier Henri LaboritRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional Group

Control group

Arm Description

Patients in this arm will have 6 sessions of virtual reality in a pod (1 session per week). Patients will then have a visit at day 90 and day 180.

Patients in this arm will receive the gold standard of treatment for tobacco cessation (nicotine patches and chewing gum) from day 0 (inclusion visit) to day 90. Patients will then have a visit at day 90 and day 180.

Outcomes

Primary Outcome Measures

Relapse at 3 months
Relapse of patients by declaring their consumption at 3 months.
Relapse at 6 months
Relapse of patients by declaring their consumption at 6 months.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2023
Last Updated
August 18, 2023
Sponsor
Centre Hospitalier Henri Laborit
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1. Study Identification

Unique Protocol Identification Number
NCT05766553
Brief Title
Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
Acronym
VIREAMIND
Official Title
Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
October 15, 2026 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigators seek to propose a non-drug therapeutic alternative, namely a mindfulness meditation protocol based on virtual reality training in order to induce progressive modifications of various indicators of craving. The study hypothesis is that the practice of mindfulness meditation in a virtual reality environment reduces the craving induced by cues and stress and therefore ultimately smoking relapse. The main objective of the protocol will be to demonstrate that mindfulness meditation can reduce long-term relapse (continuous cessation (> 30 days) of smoking cessation). The participants will be randomized into two groups: the experimental group will perform six virtual reality sessions in a multisensory cabin at the rate of one session per week; the control group will be prescribed the gold standard treatment (nicotine patches and chewing gum). Participants will be seen again at three and six months to assess whether or not there has been a smoking relapse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
relapse, craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Patients in this arm will have 6 sessions of virtual reality in a pod (1 session per week). Patients will then have a visit at day 90 and day 180.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive the gold standard of treatment for tobacco cessation (nicotine patches and chewing gum) from day 0 (inclusion visit) to day 90. Patients will then have a visit at day 90 and day 180.
Intervention Type
Other
Intervention Name(s)
Virtual reality pod
Intervention Description
The first two sessions provide guided training in relaxation and mindfulness through immersion in a virtual forest environment for the first session, and in a virtual beach environment for the second. Sessions 3 and 4 present environments with addiction-related stimuli (Cues). The session 3 consists of a walk through the virtual street environment, buying a bottle of water from the store, and then ordering a coffee from a virtual bar. The session 4 takes place in a virtual party environment in an apartment: people smoke and drink alcohol in the living room, the session consists of sitting with them, then going to the kitchen to get a water bottle. Sessions 5 and 6 present stressful environments. Session 5 consists of a virtual parachute jump. The 6th session takes place in a virtual airplane environment, which will encounter turbulence.
Intervention Type
Other
Intervention Name(s)
nicotine patches and chewing gum
Intervention Description
Participants in this group will be prescribed a Gold Standard smoking cessation treatment with nicotine patches adapted to their consumption and 4mg nicotine chewing gum for a period of 3 months.
Primary Outcome Measure Information:
Title
Relapse at 3 months
Description
Relapse of patients by declaring their consumption at 3 months.
Time Frame
3 months
Title
Relapse at 6 months
Description
Relapse of patients by declaring their consumption at 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient consuming 10 to 40 cigarettes per day Woman or man aged 18 to 75 inclusive Substance use disorder according to the DSM5 classification Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person Having signed the informed consent form after having received written information. Exclusion Criteria: Disabling cognitive disorders Patient under 18 or over 75 years old. Patient with a psychological disorder or a psychiatric pathology requiring specialized follow-up Patient with addiction to another product. Cardiological pathologies that could compromise the participation of patients, detected by an ECG (only for patients who will be randomized in the experimental group). Advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor Pregnant or breastfeeding woman Simultaneous participation in another trial Employee of the investigator or of the clinical trial site Patients protected by law Patients who do not speak the French language People not covered by state health insurance Patients who in the opinion of the investigator are unable to complete the questionnaires Patient claustrophobic or anxious about using the cabin Patient allergic to a molecule present in nicotine substitutes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nematollah JAAFARI
Phone
+33 5 16 52 61 18
Email
nemat.jaafari@ch-poitiers.fr
Facility Information:
Facility Name
Cabinet Médical
City
Iteuil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Besnier, MD
Email
marc.besnier@hotmail.fr
Facility Name
Cabinet médical des Couronneries
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lakshmipriya LE BONHEUR, MD
Email
lak.lebonheur@gmail.com
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nemat Jaafari, PU-PH
Email
nemat.jaafari@ch-poitiers.fr

12. IPD Sharing Statement

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Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation

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