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

NCT03575468 | Completed Results

• 1 other identifier: 1R21DA042960-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

e-cigarette; vaping; electronic nicotine delivery system (ENDS); smoking cessation

Outcome Measures

Primary Outcomes (2)

• Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied)

  In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond "I don't know" or "I prefer not to answer". On scale 1-6, 1 is the best outcome.

  3 months after baseline

• Treatment Engagement: Call Completion

  In Phase 2, call completion (captured via standard quitline data systems) will be compared for EEC and TAU participants. There is no limit to number of calls that can be completed, although participants are called to complete 5 scheduled calls (best outcome).

  Phase 2 time frame: 3 months after baseline

Secondary Outcomes (4)

• Quit Plan Development Experience

  3 months after baseline

• Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes

  Phase 2 time frame: 3 months after baseline

• Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes

  Phase 2 time frame: 3 months after baseline

• Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS

  Phase 2 time frame: 3 months after baseline

Other Outcomes (2)

• 7-Day Point Prevalence Smoking Cessation Rates

  Phase 2 time frame: 3 months after baseline

• Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes

  Up to 12 weeks

Study Arms (2)

Enhanced E-cigarette Coaching (EEC)

EXPERIMENTAL

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: Enhanced E-cigarette Coaching

Quitline treatment as usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Quitline treatment as usual

Interventions

Enhanced E-cigarette Coaching 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.

Also known as: EEC

Enhanced E-cigarette Coaching (EEC)

Quitline treatment as usual 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.

Also known as: TAU

Quitline treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Consumer Wellness Solutions: lead
• University of Oklahoma: collaborator
• SRI International: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

Optum

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 34568637 RESULT

MeSH Terms

Conditions

Smoking Cessation; Vaping

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Results Point of Contact

• Title: Dr. Katrina Vickerman
• Organization: Consumer Wellness Solutions

katrina.vickerman@optum.com

469-608-4208

Study Officials

• Katrina Vickerman, PHD

  Optum, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 2, 2018
• Study Start: May 7, 2018
• Primary Completion: August 31, 2020
• Study Completion: October 1, 2020
• Last Updated: October 16, 2023
• Results First Posted: September 10, 2022

Record last verified: 2023-10

Locations

US (1)