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Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation

NCT04610931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-02-04

No results posted yet for this study

Summary

Tobacco is an addiction with serious consequences: somatic, psychiatric... The number of requests for treatment for tobacco addiction is gradually increasing from year to year, but conventional treatments have limited effectiveness. 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. The investigator will then evaluate the effect of this cybertherapy on patients' relapse time and their desire to smoke.

Conditions

  • Tobacco Use Cessation

Interventions

BEHAVIORAL

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

Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage. Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups. Subjects in the Virtual Reality group will receive 6 weekly individual CBT sessions followed by 6 virtual therapy sessions. Virtual therapy consists of exposing the patient to 3D situations considered to cause a high risk of smoking relapse and aiming to reduce signal reactivity by extinction. At each session, a neutral exposure will be given at the beginning to facilitate immersion and emergence of the session with a duration determined according to the sensitivity of each patient. Exposure is stopped when the craving approaches the baseline level.

BEHAVIORAL

cognitive behavior therapy

Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage. Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups.

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • University Hospital, Clermont-Ferrand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-02
Primary Completion
2026-01-07
Completion
2026-01-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610931 on ClinicalTrials.gov