A Text Messaging Program for Smokers in Primary Care
Completed · Phase 4
Conditions studied: Smoking Cessation
In brief
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.
Key facts
- Study ID
- NCT03174158
- Run by
- Massachusetts General Hospital
- People needed
- 153
- Starts
- 2017-11-06
- Expected to finish
- 2019-02-28
- Last updated by the study team
- 2020-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massacusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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