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

Milton S. Hershey Medical Center1 site in 1 country152 target enrollmentJanuary 2015

ConditionsNicotine Dependence, Cigarettes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nicotine Dependence, Cigarettes
Sponsor: Milton S. Hershey Medical Center
Enrollment: 152
Locations: 1
Primary Endpoint: Sustained Abstinence at the 12-week Follow up
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

October 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Milton S. Hershey Medical Center

Responsible Party

Principal Investigator

Jonathan Foulds

Professor

Milton S. Hershey Medical Center

Eligibility Criteria

Inclusion Criteria

•Smoke \>4 cigarettes/day for at least 6 months
•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

Outcomes

Primary Outcomes

Sustained Abstinence at the 12-week Follow up

Time Frame: 12 weeks

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

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 Outcomes

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