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Recruiting NCT06196489

Adapting an Intervention for Vaping in Young Veterans

No phase Interventional E Cigarette Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: adapted vaping cessation intervention.
Who it may be relevant to
Registry conditions: E Cigarette Use. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Nicotine Cessation: Adapting a Counseling Program for Emerging Adults

Overview

The objective of this proposal is to adapt an evidence-based combustible tobacco counseling intervention following an evidence-based process to include e-cigarette use and update its components for emerging adults (EA). 1. Examine factors related to e-cigarette use, barriers to cessation, and facilitators of use of cessation services among an EA population. 2. Beta-test an initial version of the intervention, delivered via video telehealth and telephone, to examine usability and acceptability.

Detailed description

Use of electronic nicotine products (ENDS) has increased dramatically especially among young adults (EA- aged 18-30) and has been found to lead to immediate harmful health effects and increased addiction to combustible cigarette use. To date no research-tested interventions have been developed for helping people stop use of electronic nicotine products. Emerging adulthood is a developmental period that can lead to adoption of health risk behaviors.

This proposal aims to address nicotine addiction by adapting an evidence-based counseling cessation intervention developed by the American Cancer Society (ACS) for a general population of combustible tobacco smokers, but found to be effective in EA. We will test two methods of providing counseling to participants: video telehealth or telephone. Primary outcome: Compared to self-help guide only, at 3 month follow-up, we hypothesize that participants in either counseling arm will have higher rates as compared to self-help only control of 7-day abstinence from using any nicotine product.

This study fills a critical gap in ENDS research and will provide a model for further research into all-nicotine cessation in this vulnerable population.

Interventions

  • Behavioral adapted vaping cessation intervention
    Behavioral intervention for vaping cessation

Primary outcome measures

  • e-cigarette use frequency [Time frame: end of treatment (8 weeks post-baseline) and 30 days thereafter]
  • e-cigarette use quantity [Time frame: end of treatment (8 weeks post-baseline) and 30 days thereafter]
  • Client Satisfaction Questionnaire (CSQ-8) [Time frame: end of treatment (8 weeks post-baseline) and 30 days thereafter]

Eligibility criteria

Inclusion criteria

  • daily e-cigarette user for at least the past 6 months
  • 18-30 years old
  • willing to enroll in a program to quit nicotine use within 30 days
  • owns smartphone or computer/tablet with camera and internet connectivity
  • English speaker

Exclusion criteria

  • ICD-10 diagnosis of dementia
  • current use of combustible tobacco products at least weekly

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
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Veterans Medical Research Foundation — San Diego

Publications

  • Palmer AM, Tomko RL, Squeglia LM, Gray KM, Carpenter MJ, Smith TT, Dahne J, Toll BA, McClure EA. A pilot feasibility study of a behavioral intervention for nicotine vaping cessation among young adults delivered via telehealth. Drug Alcohol Depend. 2022 Mar 1;232:109311. doi: 10.1016/j.drugalcdep.2022.109311. Epub 2022 Jan 19. PMID 35123362
  • Kinouani S, Leflot C, Vanderkam P, Auriacombe M, Langlois E, Tzourio C. Motivations for using electronic cigarettes in young adults: A systematic review. Subst Abus. 2020;41(3):315-322. doi: 10.1080/08897077.2019.1671937. Epub 2019 Oct 22. PMID 31638872
  • Harrell PT, Brandon TH, Stark SE, Simmons VN, Barnett TE, Quinn GP, Chun S. Measuring vaping-related expectancies in young adults: Psychometric evaluation of the Electronic Nicotine Vaping Outcomes (ENVO) scale. Drug Alcohol Depend. 2023 May 1;246:109861. doi: 10.1016/j.drugalcdep.2023.109861. Epub 2023 Mar 29. PMID 37028105
  • Cuccia AF, Patel M, Amato MS, Stephens DK, Yoon SN, Vallone DM. Quitting e-cigarettes: Quit attempts and quit intentions among youth and young adults. Prev Med Rep. 2021 Jan 5;21:101287. doi: 10.1016/j.pmedr.2020.101287. eCollection 2021 Mar. PMID 33489721
  • Buu A, Hu YH, Wong SW, Lin HC. Comparing American college and noncollege young adults on e-cigarette use patterns including polysubstance use and reasons for using e-cigarettes. J Am Coll Health. 2020 Aug-Sep;68(6):610-616. doi: 10.1080/07448481.2019.1583662. Epub 2019 Mar 25. PMID 30908151
  • Bandi P, Star J, Minihan AK, Patel M, Nargis N, Jemal A. Changes in E-Cigarette Use Among U.S. Adults, 2019-2021. Am J Prev Med. 2023 Aug;65(2):322-326. doi: 10.1016/j.amepre.2023.02.026. Epub 2023 Apr 18. PMID 37479423

Identifiers

NCT: NCT06196489 · VeteransMRF · T31P1525

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗