A Text Messaging Program for Smokers in Primary Care

NCT03174158 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 2017P0009601K23DA038717-01A1
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Keywords

text messaging

Outcome Measures

Primary Outcomes (1)

• Quit Attempts

  Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more ("During the past 12 weeks, have you quit smoking intentionally for 1 day or longer").

  End of treatment (12 week post-enrollment)

Secondary Outcomes (8)

• 7 Day Point Prevalent Abstinence

  6 weeks post-enrollment

• 7 Day Point Prevalent Abstinence

  12 weeks post-enrollment (end of treatment)

• Milligrams of Nicotine Medication Used

  week 2 post enrollment

• Percentage of Days Not Smoked

  12 weeks post-enrollment (end of treatment)

• Exhaled Carbon Monoxide

  12 weeks post-enrollment (end of treatment)

Study Arms (4)

Brief advice

ACTIVE COMPARATOR

Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.

Behavioral: Brief advice

Text messaging

EXPERIMENTAL

Patients randomized to the text messaging program are offered a 12-week text messaging. The text messaging intervention will use content from the National Cancer Institute's SmokeFreeTXT library, content for smokers not ready to quit from SmokeFreeTXT and a pilot feasibility study conducted by the PI, and new messages supporting nicotine replacement medication adherence. The text messaging program will be personalized using subject's first name, the telephone number for the Massachusetts General Hospital (MGH) tobacco cessation counseling services and the Massachusetts state quitline. Smokers receiving the intervention will be sent from 0 and 5 text messages per day.

Behavioral: Text messaging; Behavioral: Brief advice

Mailed nicotine replacement therapy

EXPERIMENTAL

Subjects randomized to mailed nicotine replacement therapy will be offered a 2 week supply of nicotine replacement therapy mailed to their home address. Daily smokers planning to quit in the next 30 days will be offered nicotine patches (14 or 21 mg patches) and lozenges (2 or 4 mg lozenges) dosed according to package instructions. Non-daily smokers planning to quit will be offered a 2 week allotment of 2 mg lozenges alone. Smokers not planning to quit will be offered one box of lozenges (72 count box of 4 mg or 2 mg lozenges based on time to first cigarette as above per package instructions) to use when they are not smoking during their practice quit attempt.

Drug: Mailed nicotine replacement therapy; Behavioral: Brief advice

Text messaging + mailed NRT

EXPERIMENTAL

Subjects will be offered both the 12 week text message program and 2 weeks of mailed nicotine replacement therapy.

Drug: Mailed nicotine replacement therapy; Behavioral: Text messaging; Behavioral: Brief advice

Interventions

Mailed nicotine replacement therapy DRUG

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.

Mailed nicotine replacement therapy; Text messaging + mailed NRT

Text messaging BEHAVIORAL

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.

Text messaging; Text messaging + mailed NRT

Brief advice BEHAVIORAL

Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training

Brief advice; Mailed nicotine replacement therapy; Text messaging; Text messaging + mailed NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Massacusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Kruse GR, Park ER, Chang Y, Haberer JE, Abroms LC, Shahid NN, Howard S, Haas JS, Rigotti NA. Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1509-1514. doi: 10.1093/ntr/ntaa050.

  PMID: 32198520 DERIVED

• Kruse GR, Park E, Haberer JE, Abroms L, Shahid NN, Howard SE, Chang Y, Haas JS, Rigotti NA. Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol. Contemp Clin Trials. 2019 May;80:48-54. doi: 10.1016/j.cct.2019.03.006. Epub 2019 Mar 25.

  PMID: 30923022 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Gina Kruse
• Organization: Massachusetts General Hospital

gkruse@partners.org

6177243157

Study Officials

• Gina R Kruse, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Medicine

Model Details: 4 arm randomized controlled trial

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: November 6, 2017
• Primary Completion: January 17, 2019
• Study Completion: February 28, 2019
• Last Updated: February 7, 2020
• Results First Posted: February 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)