Penn State TXT2Quit Study

Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence, Cigarettes
• Intervention / Treatment: Behavioral: Motivational Text Messages; Behavioral: Control

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Behavioral: Control; Usual Care. All participants receive the active medication, Varenicline.
Experimental: Motivational Text Messages	Behavioral: Motivational Text Messages; Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• Yingst JM, Veldheer S, Hrabovsky S, Hammett E, Nicholson J, Berg A, Foulds J. Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care. J Health Commun. 2018;23(4):370-378. doi: 10.1080/10810730.2018.1453890. Epub 2018 Mar 26.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 41720

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No