Clinical trial NCT03575468: Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
Official title: Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: e-cigarette
vaping
electronic nicotine delivery system (ENDS)
smoking cessation
Lead sponsor: Consumer Wellness Solutions
Sponsor class: INDUSTRY
Collaborators: name: University of Oklahoma
name: SRI International
name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2018-07-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied)
timeFrame: 3 months after baseline
measure: Treatment Engagement: Call Completion
timeFrame: Phase 2 time frame: 3 months after baseline
Secondary outcomes:
measure: Quit Plan Development Experience
timeFrame: 3 months after baseline
measure: Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
timeFrame: Phase 2 time frame: 3 months after baseline
measure: Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
timeFrame: Phase 2 time frame: 3 months after baseline
measure: Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
timeFrame: Phase 2 time frame: 3 months after baseline
Other outcomes:
measure: 7-Day Point Prevalence Smoking Cessation Rates
timeFrame: Phase 2 time frame: 3 months after baseline
measure: Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes
timeFrame: Up to 12 weeks
Locations:
city: Seattle
country: United States
facility: Optum
state: Washington
Study officials:
affiliation: Optum, Inc.
name: Katrina Vickerman, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.