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Completed

NCT Number: NCT02136498

My Mobile Advice Program: A Randomized Pilot Feasibility Study

The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Health Research Institute

Seattle, Washington, 98101, United States

About this study

Investigators will develop and pilot test a prototype of the MyMAP intervention.The intervention is designed to help smokers better manage issues known to reduce treatment adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate behavioral skills for medication adherence) and to facilitate greater communication between patients and providers so clinicians can provide appropriate oversight of medication use, intervene when medically necessary, and address patient concerns that may otherwise lead to non-adherence or early treatment termination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An invited member of Group Health, a health care system in the Pacific Northwest
  • Plan to remain enrolled in Group Health for the next 6 months
  • aged 18 - 65
  • Eligible for smoking cessation treatment through Group Health insurance coverage
  • smoke >= 10 cigs a day
  • speak and read in English
  • willing to use varenicline and no contraindications for this medication
  • ready to quit smoking
  • have a smart phone with internet access
  • willing to receive study texts and emails
  • receive care at a Group Health clinic and have electronic medical records in this system
  • fill prescriptions through the Group Health pharmacy
  • agree to use birth control while taking study medication, if there is a risk of pregnancy

Exclusion criteria

  • lifetime history of dementia
  • psychosis or bipolar disorder based on self-report or medical record review
  • hearing, comprehension or visual limitations that preclude full study participation
  • current use of other forms of tobacco
  • any medical contraindication for varenicline use
  • documented history of suicidal ideation/intent

Treatment and study plan

Varenicline

Drug

Standard 12 week course of varenicline, provided in both arms

Other names: Chantix

Cognitive-behavioral self-help

Behavioral

Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.

MyMAP (My Mobile Advice Program)

Behavioral

Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor

Primary outcomes

  1. Point Prevalence Abstinence

    Time frame: 5 month follow-up

    Self-report of no-smoking, even a puff during the last 7 days.

Secondary outcomes

  1. Number of Days of Varenicline Use

    Time frame: 5 mo follow-up

    Number of days varenicline was used

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • University of California, Davis
  • University of Michigan

Registry information

Official study title

Internet-based Medication Adherence Program for Nicotine Dependence Treatment

Acronym: MyMAP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 13, 2014
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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