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

Study results available
· View outcomes & findings →

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502200 on ClinicalTrials.gov