NCT03502200

Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures

Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

There remains a lack of prospective and controlled research on the behavioral, toxicological, and physiological effects of electronic cigarettes (ECs) to help the public health community come to a clear and accurate consensus on their risk-benefit. In order to successfully execute the proposed study, the investigators plan to recruit and enroll recent smoking cessation treatment failures from a state QL, which predominately serves priority populations (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b) QL treatment as usual with combination nicotine replacement therapy control (NRT).

Conditions

• Smoking, Cigarette

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-15
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2018-04-18
• Last updated: 2023-07-21
• Results posted: 2023-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study