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

The Ohio State University

Status

Completed

Conditions

Smoking, Cigarette

Treatments

Device: JUUL

Other: Treatment As Usual

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03502200

OSU-19133

U01DA045537 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment

350 patients

Sex

All

Ages

21 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

smoke ≥5 cigarettes per day for the past year
read, write, and speak in English
report at least minimal interest in switching to an alternative product (> "not at all" on a Likert scale)
participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months.

Exclusion criteria

<21 years old
report NRT use or making a quit attempt within the last 7 days
current daily use of an e-cigarette over last month.
unstable or significant medical condition such as respiratory, kidney, or liver disease
unstable or significant psychiatric conditions (past and stable conditions will be allowed)
history of cardiac event or distress within the past 6 months
currently pregnant, planning to become pregnant, or breastfeeding.
currently enrolled in a contradictory study.
cohabitates with a currently enrolled participant in the REACH study
reaction to using patch medication or adhesive tape
known allergy to propylene glycol or vegetable glycerin