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Completed

NCT Number: NCT02367391

Penn State TXT2Quit Study

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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Key information

Conditions

Nicotine Dependence, Cigarettes Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Text Messages

Behavioral

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

Control

Behavioral

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

Primary outcomes

  1. 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

  2. Sustained Abstinence at the 12-week Follow up

    Time frame: 12 weeks

  3. Number of Days of Varenicline Use

    Time frame: 12 weeks

  4. Number of Active Smoking Cessation Activities Used

    Time frame: 12 weeks

    Number of activities completed out of 6

Secondary outcomes

  1. Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.

    Time frame: 12 weeks

  2. Time (in Days) to Relapse After the Target Quit Day

    Time frame: 12 weeks

  3. Total Score on the Positive Smoking Cessation Activities Measure

    Time frame: 12 weeks

    Total score for 6 items (scored 0-3). Total score range 0-18.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2015
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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