Penn State TXT2Quit Study

Overview

This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.

Full Title of Study: “Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: October 2015

Interventions

  • Behavioral: Motivational Text Messages
    • Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
  • Behavioral: Control
    • Usual Care. All participants receive the active medication, Varenicline.

Arms, Groups and Cohorts

  • Experimental: Motivational Text Messages
  • Sham Comparator: Control

Clinical Trial Outcome Measures

Primary Measures

  • Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
    • Time Frame: 12 weeks
  • Sustained Abstinence at the 12-week Follow up
    • Time Frame: 12 weeks
  • Number of Days of Varenicline Use
    • Time Frame: 12 weeks
  • Number of Active Smoking Cessation Activities Used
    • Time Frame: 12 weeks
    • Number of activities completed out of 6

Secondary Measures

  • Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
    • Time Frame: 12 weeks
  • Time (in Days) to Relapse After the Target Quit Day
    • Time Frame: 12 weeks
  • Total Score on the Positive Smoking Cessation Activities Measure
    • Time Frame: 12 weeks
    • Total score for 6 items (scored 0-3). Total score range 0-18.

Participating in This Clinical Trial

Inclusion Criteria

  • Smoke >4 cigarettes/day for at least 6 months – Age 21+ – Want to quit and ready to try in next 30 days – Willing to quit all forms of tobacco (including e-cigs) – Willing to use Chantix to try to quit – Have a cell phone able to receive text messages – Willing to attend 3 visits and use varenicline for smoking cessation – Plan to live in local area for next 6 months – Read and write in English – Women not pregnant and taking steps to avoid – Able to understand and willing to sign consent Exclusion Criteria:

  • History of allergic reaction or other adverse event while using varenicline – Used a smoking cessation aid/medicine in past 1 month (including e-cigs) – Currently pregnant or nursing – Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts – Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months – Uses non-cigarette tobacco products and does not plan to quit all tobacco. – Has a history of kidney problems or receives dialysis – Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks – Had a heart attack in the past 4 weeks – Mental conditions that would prohibit the participant from completing the protocol

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Milton S. Hershey Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jonathan Foulds, Professor – Milton S. Hershey Medical Center

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