Penn State TXT2Quit Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nicotine Dependence, Cigarettes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Motivational Text Messages

Group Type EXPERIMENTAL

Motivational Text Messages

Intervention Type BEHAVIORAL

Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.

Control

Group Type SHAM_COMPARATOR

Control

Intervention Type BEHAVIORAL

Usual Care. All participants receive the active medication, Varenicline.

Interventions

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Motivational Text Messages

Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.

Intervention Type BEHAVIORAL

Control

Usual Care. All participants receive the active medication, Varenicline.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes