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

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Difference in CBT sessions attended [Time frame: 12 Weeks]
• Time spent practicing CBT skills [Time frame: Weeks 1-12]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 29546379

Identifiers

NCT: NCT07223879 · Pro00087216 · 4R44DA059018-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗