Trial of Novel, On-Demand Virtual Reality to Amplify Practice Efficacy (NO VAPE) Added to Cognitive Behavioral Therapy for Nicotine Vaping Cessation (NO VAPE)

October 31, 2025 updated by: Charles River Analytics

Single Blind, Parallel Group Trial of Novel, On-Demand Virtual Reality to Amplify Practice Efficacy (NO VAPE) Added to Cognitive Behavioral Therapy for Nicotine Vaping Cessation

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 propose a prospective, randomized, single-blind, trial with 90 individuals aged 16 years and over who vape nicotine at least weekly for three months, and wish to quit vaping within the next month. Subjects will be randomly assigned to either the experimental (NO VAPE + CBT) or control group (sham NO VAPE + CBT) for 12 weeks. The study will use a double blind design where both subjects and investigators and outcome assessors will be masked to subjects' group assignments. The experimental group will receive the following over a 12-week period: NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program for vaping cessation. The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program. The VR app will be used at home by participants in between CBT session visits. Participants will also briefly report their CBT skills practice using the MyCap smartphone app. Participants will be assigned randomly to the experimental or control group in a 1:1 ratio, with randomization blocks of 6, stratified by no/mild nicotine dependence (Electronic Cigarette Dependence Index [ECDI] score 0-8) or moderate/high nicotine dependence (ECDI score 9 or higher) in a prospective trial in people age 16 and over, who use vaped nicotine regularly and wish to quit vaping.

The primary outcome is self-reported time spent in CBT skills practice per week. Groups will be compared on mean number of days and duration of self-reported CBT skill practice per week over the 12-week treatment period.

Secondary outcomes are: tolerability and feasibility of the NO VAPE virtual reality (VR) vaping cessation tool, which will be assessed by the following self-reported ratings in both groups: a) average CBT session attendance weekly, b) satisfaction ratings, c) adverse events; and by the following self-reported ratings d) self-ratings of the virtual reality application usability, e) engagement, f) presence, and g) simulator cyber sickness.

Exploratory outcomes are: 1) biochemically verified 7-day point prevalence vaping abstinence at week 12, and 2) 4-week biochemically verified continuous abstinence from weeks 9-12.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NO VAPE + 12 weeks CBT
The experimental group will receive the following over a 12-week period: NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program for vaping cessation.
Behavioral: NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment program
The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.
Sham Comparator: Sham NO VAPE + 12 weeks CBT
The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.
Behavioral: Sham VR app without CBT-embedded content with a 12-session individual CBT treatment program
The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in CBT sessions attended
Time Frame: 12 Weeks
We will evaluate the number of CBT sessions attended across the 12 weeks
12 Weeks
Time spent practicing CBT skills
Time Frame: Weeks 1-12
We time spent practicing CBT between sessions in minutes. The app collects data automatically on how much time is spent using it, and how much time is spent within each environment.
Weeks 1-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in craving
Time Frame: Weeks 1-12
We will measure changes in craving at enrollment and weekly using a brief, 10-item, valid and reliable measure of vaping craving that queries desire and intent to vape and anticipation of positive outcomes related to e-cigarette use.
Weeks 1-12
Change in withdrawal symptoms
Time Frame: Weeks 1-12
We will measure changes in withdrawal symptoms using the Minnesota Nicotine Withdrawal Scale (MNWS)
Weeks 1-12
Change in severity of tobacco use disorder (TUD)
Time Frame: Week 12
We will evaluate the impact of the intervention on reducing the severity of tobacco use disorder (TUD). Severity of TUD is operationalized as Electronic Cigarette Dependence Index (ECDI; Foulds et al., 2015) total score, (range 0-20).
Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Vaping Abstinence
Time Frame: week 12
Exploratory outcome 1 is biochemically verified 7-day point prevalence vaping abstinence at week 12.
week 12
4-Week Vaping Abstinence
Time Frame: weeks 9-12
Exploratory outcome 2 is 4-week biochemically verified continuous abstinence from weeks 9-12.
weeks 9-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles River Analytics

Collaborators

National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

October 24, 2025

First Submitted That Met QC Criteria

October 31, 2025

First Posted (Estimated)

November 3, 2025

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00087216
  • 4R44DA059018-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Deidentified IPD collected throughout the trial

IPD Sharing Time Frame

Feb 2029

IPD Sharing Access Criteria

They must request access through Charles River Analytics.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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