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

NCT ID: NCT03575468

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2020-10-01

Brief 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.

Detailed Description

The specific aims of this research are to:

1. Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention.

2. Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids.

3. Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced E-cigarette Coaching (EEC)

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.

Group Type: EXPERIMENTAL

Enhanced E-cigarette Coaching

Intervention Type: BEHAVIORAL

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.

Quitline treatment as usual (TAU)

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.

Group Type: ACTIVE_COMPARATOR

Quitline treatment as usual

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EEC; TAU

Eligibility Criteria

Inclusion Criteria

• • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program

• Currently using e-cigarettes
• Indicated plan to use e-cigarettes in the next 30 days
• English Speaking
• 18+ years old
• Willing to quit cigarettes in the next 30 days
• Consented to receive automated phone outreach via the quitline (TCPA consented)
• Has an Android smartphone with an operating system of 6.0 or higher and comfort downloading and using apps on phone
• Has regular access to email
• Callback best time between the hours of 6:00 am - 3:00 pm Pacific Standard Time

Exclusion Criteria

• • Pregnant or Planning pregnancy within 3 months

• Reported Schizophrenia diagnosis history during registration
• Heart attack past 2 weeks
• Stroke/Transient Ischemic Attack past 2 weeks
• Rapid Irregular heart beat past 6 months
• Angina or heart pain past 6 months
• Currently taking Varenicline (also known as Chantix) or Bupropion (also known as Wellbutrin or Zyban)
• Previously screened for study
• Enrolled via proxy (i.e., did not self-enroll)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: collaborator

SRI International

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: collaborator

Consumer Wellness Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrina Vickerman, PHD

Role: PRINCIPAL_INVESTIGATOR

Optum, Inc.

Locations

Optum

Seattle, Washington, United States

Countries

United States

References

Vickerman KA, Carpenter KM, Miles LN, Hsu JM, Watt KA, Brandon TH, Hart JT, Javitz HS, Wagener TL. Treatment development, implementation, and participant baseline characteristics: A randomized pilot study of a tailored quitline intervention for individuals who smoke and vape. Contemp Clin Trials Commun. 2021 Sep 8;24:100845. doi: 10.1016/j.conctc.2021.100845. eCollection 2021 Dec.

Reference Type: RESULT

PMID: 34568637 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R21DA042960-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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