A Text Messaging Program for Smokers in Primary Care
Condition: Smoking Cessation
Intervention: Mailed nicotine replacement therapy; Text messaging; Brief advice
Intervention description: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.; 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.; Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 arm randomized controlled trial
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: text messaging

Summary:

      This study is a four arm pilot randomized controlled trial testing the effect of a 12 week
      text messaging intervention and a mailed nicotine medication intervention, alone and in
      combination to a control condition consisting of brief behavioral advice and usual care.

      Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the
      effect of a text messaging program and mailed nicotine replacement therapy on smoking
      outcomes and medication use.

      Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a
      quit attempt compared to smokers receiving no text messaging.

      Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement
      therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy.

      Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed
      past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects
      receiving no text messaging intervention.

      Hypothesis 4: A text messaging intervention will increase the number of days not smoking
      compared to subjects receiving no text messaging intervention.

      Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per
      day compared to subjects receiving no text messaging intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (≥18 years)

          -  Smoking status of current smoker in structured field of electronic health record (EHR)

          -  Language listed as English in EHR

          -  Massachusetts General Hospital patient, Partners healthcare primary care provider
             (PCP)

          -  PCP visit in the past 2 years

          -  Mobile telephone number listed in EHR

        Exclusion Criteria:

          -  Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or
             self-report of less than daily current smoking

          -  Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.

          -  Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.

          -  Past 30-day use of Massachusetts state quit-line, "QuitWorks" or SmokefreeTXT programs

          -  Prior serious adverse reaction to the nicotine patch or lozenge defined as any
             reaction that was life-threatening, required hospitalization, or other clinical
             evaluation

          -  Ever had an allergy to nicotine patch

          -  Weight < 100 pounds

          -  Unstable coronary disease

          -  Unstable arrhythmia

          -  Dementia or active psychosis or schizoaffective disorder affecting ability to consent

          -  Willing and able to receive and participate with a text message program for up to 12
             weeks