Clinical trial NCT02367391: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence, Cigarettes
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 152
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
timeFrame: 12 weeks
measure: Sustained Abstinence at the 12-week Follow up
timeFrame: 12 weeks
measure: Number of Days of Varenicline Use
timeFrame: 12 weeks
measure: Number of Active Smoking Cessation Activities Used
timeFrame: 12 weeks
Secondary outcomes:
measure: Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
timeFrame: 12 weeks
measure: Time (in Days) to Relapse After the Target Quit Day
timeFrame: 12 weeks
measure: Total Score on the Positive Smoking Cessation Activities Measure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References:
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.