NO VAPE + 12 Weeks of Standard CBT, Sham NO VAPE + 12 Weeks Standard CBT
Conditions
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 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
BEHAVIORALNO 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.
BEHAVIORALSham 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Charles River Analytics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in CBT sessions attended | 12 Weeks | We will evaluate the number of CBT sessions attended across the 12 weeks |
| Time spent practicing CBT skills | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in severity of tobacco use disorder (TUD) | 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). |
| Change in withdrawal symptoms | Weeks 1-12 | We will measure changes in withdrawal symptoms using the Minnesota Nicotine Withdrawal Scale (MNWS) |
| Change in craving | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point Prevalence Vaping Abstinence | week 12 | Exploratory outcome 1 is biochemically verified 7-day point prevalence vaping abstinence at week 12. |
| 4-Week Vaping Abstinence | weeks 9-12 | Exploratory outcome 2 is 4-week biochemically verified continuous abstinence from weeks 9-12. |
Contacts
Primary ContactBethany Bracken
Outcome results
None listed