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Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes

NCT03575468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-10-16

Study results available
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Summary

The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.

Conditions

  • Smoking Cessation

Interventions

BEHAVIORAL

Enhanced E-cigarette Coaching

The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.

BEHAVIORAL

Quitline treatment as usual

The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.

Sponsors & Collaborators

  • University of Oklahoma

    collaborator OTHER

  • SRI International

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Consumer Wellness Solutions

    lead INDUSTRY

Principal Investigators

  • Katrina Vickerman, PHD · Optum, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2020-08-31
Completion
2020-10-01

Countries

  • United States

Study Locations

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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 NCT03575468 on ClinicalTrials.gov