Status:
NOT_YET_RECRUITING
Trial of Novel, On-Demand Virtual Reality to Amplify Practice Efficacy (NO VAPE) Added to Cognitive Behavioral Therapy for Nicotine Vaping Cessation
Lead Sponsor:
Charles River Analytics
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Conditions:
NO VAPE + 12 Weeks of Standard CBT
Sham NO VAPE + 12 Weeks Standard CBT
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
3\. General Description of Study Design The proposed study will evaluate the effect of adding a VR app with CBT-embedded content to a 12-session individual CBT treatment program. Investigators propos...
Eligibility Criteria
Inclusion
- Age 16 years or older
- Report of nicotine vaping at least weekly for the prior ≥ 3 months
- Self-report of not smoking tobacco regularly at enrollment (tobacco smoking on \<8 of the past 30 days)
- Report motivation to quit vaping in the next 30 days
- Own or are willing to use a Meta Quest VR headset
- Vision corrected to within 20/50 bilaterally
- Access to a mobile device to complete daily survey assessments
- If age is greater than or equal to 18 years: Competent and willing to provide written informed consent
- If age is less than 18 years: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
Exclusion
- Individuals at greater risk of harm from virtual reality side effects, such as a history of motion sickness, history of migraines or severe headaches, history of vertigo, epilepsy or neurological conditions where visual stimuli may trigger seizures or other issues (excludes history of febrile seizures), or self-report of pregnancy, recent concussion, or other conditions that increase risks of dizziness, nausea, or headaches
- Evidence of active problem substance use severe enough, in the investigator's opinion, to compromise ability to safely participate
- Unwilling to provide saliva or urine samples
- Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol
- Individuals who are under the legal protection of the government or state (Wards of the State)
- Inability to understand study procedures, read, and write in English
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07223879
Start Date
November 1 2025
End Date
February 1 2028
Last Update
November 3 2025
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