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Smoking CessationPhase 4GR2QNCT03174158

A Text Messaging Program for Smokers in Primary Care

A Phase 4 study testing Mailed nicotine replacement therapy, Text messaging and Brief advice in people with Smoking Cessation, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Mailed nicotine replacement therapy, Text messaging and Brief advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteUnited States
Study dates
6 Nov 2017to 28 Feb 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massacusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Text Messaging Intervention for Smoking Cessation Among Community Health Center Patients

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.

Read more

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.

Read the detailed description

Background: Fifteen percent of U.S. adults continue to smoke despite the availability of effective smoking cessation treatment and healthcare systems are positioned to address this deficiency. Text messaging is a widespread technology which shows promise as a way to reach smokers and to connect them with treatment. Tobacco cessation support delivered by text message increases abstinence among smokers interested in quitting in community- or school-based settings. This has led to the creation of text messaging programs by the National Cancer Institute, SmokeFreeTXT, and others. However, little is known about the feasibility of delivering smoking cessation support by text message for smokers engaged in healthcare systems. Integrating text messaging programs within healthcare systems has clear advantages. Documentation of smoking status is one of the Meaningful Use standards. This documentation enables healthcare systems to identify their population of smokers and proactively target them with health interventions outside of the busy office visit. Text messaging programs originating from the physicians' practice may also leverage the influence physicians have on smokers' motivation to quit.

Text messaging has been used in healthcare systems to effectively improve medication adherence in other conditions. Adherence to smoking cessation medications is at least modestly associated with cessation and measures of adherence to smoking cessation medications suggest overall low adherence to cessation medications outside of clinical trials. Offering free nicotine replacement therapy along with the medication adherence advice in a text messaging intervention will allow us to evaluate of the effect of adherence messages on medication use.

Study design A pilot randomized controlled trial of 206 smokers who receive care in Massachusetts General Hospital-affiliated primary care practices will compare the effect of delivering behavioral smoking cessation content with pharmacotherapy support by text message plus nicotine replacement therapy on self-reported quit attempts (intentional non-smoking for ≥24 hours), medication adherence, days not smoked, and smoking abstinence at the end of treatment. Smokers will be identified using the electronic health record, screened by their primary care provider, and proactively contacted by telephone by a clinical research coordinator. Potential subjects will be screened for eligibility by self-report and chart review by the Principal Investigator. Eligible subjects will be stratified by practice and readiness to quit (plan to quit smoking in the next 30 days vs no plan to quit smoking/plan to quit smoking in the next 6 months) and randomized 1:1:1:1 to 4 groups using a variable block randomization.

  1. Brief advice (BA): Brief advice to quit smoking and usual care. Rationale: All subjects will receive brief advice from a trained clinical research coordinator. All primary care subjects also have access to guideline-concordant tobacco treatment through usual care with their primary care provider. Their primary care provider can refer them to in-person or telephone counseling and can prescribe medications.
  2. Nicotine replacement therapy (NRT): Brief advice + 2 weeks of nicotine patches and/or lozenges mailed to subject. Rationale: In order to test the effect of text messaging on medication adherence, we need to have treatment groups receiving medication and medication plus text messaging. To deliver medication, mailed NRT, like text messaging, reaches patients outside of the busy office visit. Mailed NRT alone has also been shown to increase cessation and may itself be an effective intervention compared to brief advice and usual care.
  3. Text messaging (TM): Brief advice + 12 week personalized, tailored text messaging program. Rationale: Text messaging shows promise as an intervention to help smokers to quit. However, it has not been well tested among primary care patients. Text messaging may connect those primary care smokers who do not access currently available treatment services like telephone counseling or prescribed medication with assistance outside of the clinic office.
  4. Text messaging and nicotine replacement therapy (TM+NRT): Brief advice + 12 week personalized, tailored text messaging program + 2 weeks of nicotine patches and/or lozenges mailed to subject. Rationale: As above, in order to test the effect of text messaging on medication adherence, we need to have treatment groups receiving medication and medication plus text messaging. Text messaging has been shown to increase medication adherence in other conditions and medication adherence is suboptimal among users of smoking cessation medications. Integrating text messaging within healthcare systems offers opportunities to coordinate with pharmacotherapy and this 4 group design allows us to test the effect of text messaging alone on smoking outcomes and the effect of text messaging on NRT use.
Being tested
Mailed nicotine replacement therapy, Text messaging, Brief advice
Keywords
text messaging
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mailed nicotine replacement therapyDrug

    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.

  • Text messagingBehavioural

    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 adviceBehavioural

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

Study groups in NCT03174158
Study groupRoleWhat they receive
Brief adviceActive comparatorUsual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
Receives: Behavioral: Brief advice
Text messagingExperimentalPatients 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.
Receives: Behavioral: Text messaging; Behavioral: Brief advice
Mailed nicotine replacement therapyExperimentalSubjects 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.
Receives: Drug: Mailed nicotine replacement therapy; Behavioral: Brief advice
Text messaging + mailed NRTExperimentalSubjects will be offered both the 12 week text message program and 2 weeks of mailed nicotine replacement therapy.
Receives: Drug: Mailed nicotine replacement therapy; Behavioral: Text messaging; Behavioral: Brief advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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").

    Measured: End of treatment (12 week post-enrollment)

Secondary outcomes (8)
  1. 7 Day Point Prevalent Abstinence

    Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?"

    Measured: 6 weeks post-enrollment

  2. 7 Day Point Prevalent Abstinence

    Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?"

    Measured: 12 weeks post-enrollment (end of treatment)

  3. Milligrams of Nicotine Medication Used

    Self-reported milligrams of nicotine medication used

    Measured: week 2 post enrollment

  4. Percentage of Days Not Smoked

    Self-reported, "In the past 30 days, how many days did you have at least one cigarette?"

    Measured: 12 weeks post-enrollment (end of treatment)

  5. Exhaled Carbon Monoxide

    Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million

    Measured: 12 weeks post-enrollment (end of treatment)

  6. Days Nicotine Medication Used

    Self-reported number of days nicotine lozenge and/or patch used

    Measured: Total reported over 2 weeks post-enrollment

  7. Milligrams Nicotine Medication Used

    Self-reported number of milligrams nicotine medication used

    Measured: Total reported over 1 week post-enrollment

  8. Change in Cigarettes Per Day

    Self-reported number of cigarettes per day on days smoked, change

    Measured: 12 weeks post enrollment (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2017
  2. Study start6 Nov 2017
  3. Primary completion17 Jan 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 arm randomized controlled trial
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03174158
Sponsor's protocol ID
2017P000960
Other IDs
1K23DA038717-01A1
Acronym
GR2Q
Status last verified
Jan 2020
First submitted
31 May 2017
Last updated
7 Feb 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32198520
  • 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.

    PubMed 30923022

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mailed nicotine replacement therapy, Text messaging and Brief advice in people with Smoking Cessation, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quit Attempts (time frame: End of treatment (12 week post-enrollment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03174158, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.

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A Text Messaging Program for Smokers in Primary Care | AzTrials