Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures
NCT03502200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2023-07-21
Summary
The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.
Conditions
- Smoking, Cigarette
Interventions
- DEVICE
-
JUUL
Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
- OTHER
-
Treatment As Usual
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Theodore L Wagener, PhD · Ohio State Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-15
- Primary Completion
- 2023-01-31
- Completion
- 2023-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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