A Text Messaging Program for Smokers in Primary Care

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

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