- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06196489
Adapting an Intervention for Vaping in Young Veterans
Nicotine Cessation: Adapting a Counseling Program for Emerging Adults
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).
- Examine factors related to e-cigarette use, barriers to cessation, and facilitators of use of cessation services among an EA population.
- Beta-test an initial version of the intervention, delivered via video telehealth and telephone, to examine usability and acceptability.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neal M Doran, PhD
- Phone Number: 858-552-8585
- Email: neal.doran@va.gov
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- Recruiting
- Veterans Medical Research Foundation
-
Contact:
- Neal Doran
- Phone Number: 858-552-8585
- Email: neal.doran@va.gov
-
Principal Investigator:
- Neal M Doran, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: telephone
Participants assigned to this group will receive the adapted intervention by telephone.
|
Behavioral intervention for vaping cessation
|
|
Experimental: Video
Participants assigned to this group will receive the adapted intervention by video telehealth.
|
Behavioral intervention for vaping cessation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
e-cigarette use frequency
Time Frame: end of treatment (8 weeks post-baseline) and 30 days thereafter
|
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
|
|
e-cigarette use quantity
Time Frame: end of treatment (8 weeks post-baseline) and 30 days thereafter
|
number of e-cigarette uses per day
|
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
|
Participant satisfaction ratings; higher scores indicate greater satisfaction with the intervention
|
end of treatment (8 weeks post-baseline) and 30 days thereafter
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Neal M Doran, PhD, Veterans Medical Research Foundation
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VeteransMRF
- T31P1525 (Other Grant/Funding Number: University of California)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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