Adapting an Intervention for Vaping in Young Veterans

E Cigarette Use Clinical Trial

Official title:

Nicotine Cessation: Adapting a Counseling Program for Emerging Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196489
• Other study ID #: VeteransMRF
• Secondary ID: T31P1525
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Veterans Medical Research Foundation
• Contact: Neal M Doran, PhD
• Phone: 858-552-8585
• Email: neal.doran[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• E Cigarette Use

Intervention

Behavioral:
• adapted vaping cessation intervention
Behavioral intervention for vaping cessation

Locations

Country	Name	City	State
United States	Veterans Medical Research Foundation	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	University of California

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	e-cigarette use frequency	number of days using e-cigarettes in the past 7 days at the time of assessment	end of treatment (8 weeks post-baseline) and 30 days thereafter
Primary	e-cigarette use quantity	number of e-cigarette uses per day	end of treatment (8 weeks post-baseline) and 30 days thereafter
Primary	Client Satisfaction Questionnaire (CSQ-8)	Participant satisfaction ratings; higher scores indicate greater satisfaction with the intervention	end of treatment (8 weeks post-baseline) and 30 days thereafter