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

Consumer Wellness Solutions

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Enhanced E-cigarette Coaching; Behavioral: Quitline treatment as usual

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03575468

1R21DA042960-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Enhanced E-cigarette Coaching (EEC)

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced E-cigarette Coaching

Quitline treatment as usual (TAU)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Quitline treatment as usual