Penn State TXT2Quit Study

Not Applicable

Completed

• Conditions: Nicotine Dependence, Cigarettes
• Interventions: Behavioral: Motivational Text Messages; Behavioral: Control

• Registration Number: NCT02367391
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2017-01-18
• Results First Submitted QC: 2017-01-18
• Results First Posted: 2017-03-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational Text Messages	Motivational Text Messages	-
Control	Control	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States