NO VAPE + 12 Weeks of Standard CBTNO VAPENCT07223879

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

A study testing NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment program in people with NO VAPE + 12 Weeks of Standard CBT and Sham NO VAPE + 12 Weeks Standard CBT, run by Charles River Analytics.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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 propose a prospective, randomized, single-blind, trial with 90 individuals aged 16 years and over who vape nicotine at least… Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: NO VAPE + 12 Weeks of Standard CBT, Sham NO VAPE + 12 Weeks Standard CBT
What is being tested?: NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: No sites listed yet
Study dates: Nov 2025to Feb 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Bethany Bracken contact

16174913474

bbracken@cra.com

About this study

Official title: 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

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.

Conditions: NO VAPE + 12 Weeks of Standard CBT, Sham NO VAPE + 12 Weeks Standard CBT
Being tested: NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment program, Sham VR app without CBT-embedded content with a 12-session individual CBT treatment program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment programBehavioural
The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.
Sham VR app without CBT-embedded content with a 12-session individual CBT treatment programBehavioural
The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.

Study groups in NCT07223879
Study group	Role	What they receive
NO VAPE + 12 weeks CBT	Active comparator	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. Receives: Behavioral: NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment program
Sham NO VAPE + 12 weeks CBT	Sham comparator	The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program. Receives: Behavioral: Sham VR app without CBT-embedded content with a 12-session individual CBT treatment program

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in CBT sessions attended
We will evaluate the number of CBT sessions attended across the 12 weeks
Measured: 12 Weeks
Time spent practicing CBT skills
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.
Measured: Weeks 1-12

Secondary outcomes (3)

Change in craving
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.
Measured: Weeks 1-12
Change in withdrawal symptoms
We will measure changes in withdrawal symptoms using the Minnesota Nicotine Withdrawal Scale (MNWS)
Measured: Weeks 1-12
Change in severity of tobacco use disorder (TUD)
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).
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2025Feb 2028

First posted3 Nov 2025
Study startNov 2025 (estimated)
Primary completionFeb 2028 (estimated)
Study completionFeb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for NO VAPE + 12 Weeks of Standard CBTStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07223879
Sponsor's protocol ID: Pro00087216
Other IDs: 4R44DA059018-02
Acronym: NO VAPE
Status last verified: Oct 2025
First submitted: 24 Oct 2025
Last updated: 3 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All Deidentified IPD collected throughout the trial

Publications

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686
Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG. Simulator Sickness Questionnaire: An Enhanced Method for Quantifying Simulator Sickness. The International Journal of Aviation Psychology. 1993/07/01 1993;3(3):203-220. doi:10.1207/s15327108ijap0303_3
Witmer BG, Singer MJ. Measuring Presence in Virtual Environments: A Presence Questionnaire. Presence: Teleoperators and Virtual Environments. 1998;7(3):225-240. doi:10.1162/105474698565686
Lin JJW, Duh HBL, Parker DE, Abi-Rached H, Furness TA. Effects of field of view on presence, enjoyment, memory, and simulator sickness in a virtual environment. 2002:164-171.
Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.
PubMed 37009114
Meta. This is Meta Quest. Accessed 03/05/2025, 2025. https://www.meta.com/quest/?srsltid=AfmBOoojbfuf4Ht9amTr-QDOGrgC5wz7RHJ80CTGLUZ4bQ0IKlyr_V8w
Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. doi: 10.1001/archpsyc.1986.01800030107013.
PubMed 3954551
Dowd AN, Motschman CA, Tiffany ST. Development and Validation of the Questionnaire of Vaping Craving. Nicotine Tob Res. 2019 Jan 1;21(1):63-70. doi: 10.1093/ntr/nty046.
PubMed 29546379
Piper ME, Baker TB, Benowitz NL, Smith SS, Jorenby DE. E-cigarette Dependence Measures in Dual Users: Reliability and Relations With Dependence Criteria and E-cigarette Cessation. Nicotine Tob Res. 2020 Apr 21;22(5):756-763. doi: 10.1093/ntr/ntz040.
PubMed 30874804
Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26.
PubMed 20347232
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
PubMed 8329970
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
PubMed 9738608
Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014 Mar;28(1):154-62. doi: 10.1037/a0030992. Epub 2012 Dec 31.
PubMed 23276315
Wienrich C, Döllinger N, Hein R. Behavioral Framework of Immersive Technologies (BehaveFIT): How and Why Virtual Reality can Support Behavioral Change Processes. Hypothesis and Theory. Frontiers in Virtual Reality. 2021-June-24 2021;2doi:10.3389/frvir.2021.627194
Okpako T, Kale D, Perski O, Brown J. Prevalence and characteristics of smokers interested in using virtual reality for encouraging smoking cessation: a representative population survey in Great Britain. BMC Digital Health. 2024/11/12 2024;2(1):79. doi:10.1186/s44247-024-00136-2

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07223879
Acronym / sponsor ID: NO VAPE / Pro00087216
Conditions: NO VAPE + 12 Weeks of Standard CBT, Sham NO VAPE + 12 Weeks Standard CBT
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 90 participants (estimated)
Lead sponsor: Charles River AnalyticsIndustry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA), Massachusetts General Hospital
Study start: Nov 2025 (estimated)
Primary completion: Feb 2028 (estimated)
Study completion: Feb 2028 (estimated)
First posted: 3 Nov 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

General Description of Study Design

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NO VAPE + 12 weeks CBT	Active comparator	Behavioral: NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment programThe 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.
Sham NO VAPE + 12 weeks CBT	Sham comparator	Behavioral: Sham VR app without CBT-embedded content with a 12-session individual CBT treatment programThe control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment programThe control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.	Behavioural	NO VAPE + 12 weeks CBT
Sham VR app without CBT-embedded content with a 12-session individual CBT treatment programThe control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program.	Behavioural	Sham NO VAPE + 12 weeks CBT

Primary outcome

Difference in CBT sessions attended
Time frame: 12 Weeks
We will evaluate the number of CBT sessions attended across the 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.

3 secondary outcomes

Change in craving
Time frame: Weeks 1-12
Change in withdrawal symptoms
Time frame: Weeks 1-12
Change in severity of tobacco use disorder (TUD)
Time frame: Week 12

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
BackgroundKennedy RS, Lane NE, Berbaum KS, Lilienthal MG. Simulator Sickness Questionnaire: An Enhanced Method for Quantifying Simulator Sickness. The International Journal of Aviation Psychology. 1993/07/01 1993;3(3):203-220. doi:10.1207/s15327108ijap0303_3
BackgroundWitmer BG, Singer MJ. Measuring Presence in Virtual Environments: A Presence Questionnaire. Presence: Teleoperators and Virtual Environments. 1998;7(3):225-240. doi:10.1162/105474698565686
BackgroundLin JJW, Duh HBL, Parker DE, Abi-Rached H, Furness TA. Effects of field of view on presence, enjoyment, memory, and simulator sickness in a virtual environment. 2002:164-171.
Background: PubMed 37009114Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.
BackgroundMeta. This is Meta Quest. Accessed 03/05/2025, 2025. https://www.meta.com/quest/?srsltid=AfmBOoojbfuf4Ht9amTr-QDOGrgC5wz7RHJ80CTGLUZ4bQ0IKlyr_V8w
Background: PubMed 3954551Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. doi: 10.1001/archpsyc.1986.01800030107013.
Background: PubMed 29546379Dowd AN, Motschman CA, Tiffany ST. Development and Validation of the Questionnaire of Vaping Craving. Nicotine Tob Res. 2019 Jan 1;21(1):63-70. doi: 10.1093/ntr/nty046.
Background: PubMed 30874804Piper ME, Baker TB, Benowitz NL, Smith SS, Jorenby DE. E-cigarette Dependence Measures in Dual Users: Reliability and Relations With Dependence Criteria and E-cigarette Cessation. Nicotine Tob Res. 2020 Apr 21;22(5):756-763. doi: 10.1093/ntr/ntz040.
Background: PubMed 20347232Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26.
Background: PubMed 8329970Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
Background: PubMed 9738608Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
Individual participant dataSharing planned: Yes. All Deidentified IPD collected throughout the trial

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Bethany Bracken contact

16174913474

bbracken@cra.com

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bethany Bracken (16174913474, bbracken@cra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in CBT sessions attended (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07223879, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.