Clinical trial NCT06196489: Adapting an Intervention for Vaping in Young Veterans
Official title: Nicotine Cessation: Adapting a Counseling Program for Emerging Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: E Cigarette Use
Keywords: Veteran
e-cigarette
vaping
young adult
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: University of California
First posted: 2024-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: e-cigarette use frequency
timeFrame: end of treatment (8 weeks post-baseline) and 30 days thereafter
measure: e-cigarette use quantity
timeFrame: end of treatment (8 weeks post-baseline) and 30 days thereafter
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: end of treatment (8 weeks post-baseline) and 30 days thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Medical Research Foundation
state: California
Study officials:
affiliation: Veterans Medical Research Foundation
name: Neal M Doran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.