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Penn State TXT2Quit Study

Primary Purpose

Nicotine Dependence, Cigarettes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Text Messages
Control
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence, Cigarettes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Motivational Text Messages

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2015
Last Updated
May 24, 2017
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02367391
Brief Title
Penn State TXT2Quit Study
Official Title
Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Cigarettes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Text Messages
Arm Type
Experimental
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational Text Messages
Intervention Description
Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Usual Care. All participants receive the active medication, Varenicline.
Primary Outcome Measure Information:
Title
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
Title
Sustained Abstinence at the 12-week Follow up
Time Frame
12 weeks
Title
Number of Days of Varenicline Use
Time Frame
12 weeks
Title
Number of Active Smoking Cessation Activities Used
Description
Number of activities completed out of 6
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
Time Frame
12 weeks
Title
Time (in Days) to Relapse After the Target Quit Day
Time Frame
12 weeks
Title
Total Score on the Positive Smoking Cessation Activities Measure
Description
Total score for 6 items (scored 0-3). Total score range 0-18.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29578832
Citation
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.
Results Reference
derived

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Penn State TXT2Quit Study

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