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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA038717-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 7 Day Point Prevalent Abstinence | Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?" | 6 weeks post-enrollment |
| 7 Day Point Prevalent Abstinence | Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina R Kruse, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massacusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32198520 | Derived | 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. | |
| 30923022 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Advice | Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training |
| FG001 | Text Messaging | Text messaging: 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: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training |
| FG002 | Mailed Nicotine Replacement Therapy | Mailed nicotine replacement therapy: 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 lozenges. Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training |
| FG003 | Text Messaging + Mailed NRT | Mailed nicotine replacement therapy: 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 lozenges. Text messaging: 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: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Advice | Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training |
| BG001 | Text Messaging |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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"). | Posted | Count of Participants | Participants | End of treatment (12 week post-enrollment) |
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12 weeks
Adverse event data was collected at each outcome assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brief Advice | Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gina Kruse | Massachusetts General Hospital | 6177243157 | gkruse@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2018 | Jan 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
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| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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4 arm randomized controlled trial
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| Text messaging + mailed NRT | Experimental | Subjects will be offered both the 12 week text message program and 2 weeks of mailed nicotine replacement therapy. |
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| 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. |
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| Brief advice | Behavioral | Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training |
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| 12 weeks post-enrollment (end of treatment) |
| Milligrams of Nicotine Medication Used | Self-reported milligrams of nicotine medication used | week 2 post enrollment |
| Percentage of Days Not Smoked | Self-reported, "In the past 30 days, how many days did you have at least one cigarette?" | 12 weeks post-enrollment (end of treatment) |
| Exhaled Carbon Monoxide | Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million | 12 weeks post-enrollment (end of treatment) |
| Days Nicotine Medication Used | Self-reported number of days nicotine lozenge and/or patch used | Total reported over 2 weeks post-enrollment |
| Milligrams Nicotine Medication Used | Self-reported number of milligrams nicotine medication used | Total reported over 1 week post-enrollment |
| Change in Cigarettes Per Day | Self-reported number of cigarettes per day on days smoked, change | 12 weeks post enrollment (end of treatment) |
Text messaging: 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: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training
| BG002 | Mailed Nicotine Replacement Therapy | Mailed nicotine replacement therapy: 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 lozenges. Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training |
| BG003 | Text Messaging + Mailed NRT | Mailed nicotine replacement therapy: 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 lozenges. Text messaging: 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: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cigarettes per day | Mean | Standard Deviation | cigarettes per day |
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| OG002 | Mailed Nicotine Replacement Therapy | Mailed nicotine replacement therapy: 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. Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training |
| OG003 | Text Messaging + Mailed NRT | Mailed nicotine replacement therapy: 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 messaging: 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: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training |
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| Secondary | 7 Day Point Prevalent Abstinence | Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?" | Posted | Count of Participants | Participants | 6 weeks post-enrollment |
|
|
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| Secondary | 7 Day Point Prevalent Abstinence | Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?" | Posted | Count of Participants | Participants | 12 weeks post-enrollment (end of treatment) |
|
|
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| Secondary | Milligrams of Nicotine Medication Used | Self-reported milligrams of nicotine medication used | Posted | Mean | Standard Deviation | milligrams during week 2 | week 2 post enrollment |
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| Secondary | Percentage of Days Not Smoked | Self-reported, "In the past 30 days, how many days did you have at least one cigarette?" | Posted | Mean | Standard Deviation | percentage of past 30 days | 12 weeks post-enrollment (end of treatment) |
|
|
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| Secondary | Exhaled Carbon Monoxide | Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million | Posted | Count of Participants | Participants | 12 weeks post-enrollment (end of treatment) |
|
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| Secondary | Days Nicotine Medication Used | Self-reported number of days nicotine lozenge and/or patch used | Posted | Mean | Standard Deviation | days out of 2 weeks | Total reported over 2 weeks post-enrollment |
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| Secondary | Milligrams Nicotine Medication Used | Self-reported number of milligrams nicotine medication used | Posted | Mean | Standard Deviation | milligrams during week 1 | Total reported over 1 week post-enrollment |
|
|
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| Secondary | Change in Cigarettes Per Day | Self-reported number of cigarettes per day on days smoked, change | Posted | Mean | Standard Deviation | change in cigarettes per day | 12 weeks post enrollment (end of treatment) |
|
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|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Text Messaging | Text messaging: 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: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | Mailed Nicotine Replacement Therapy | Mailed nicotine replacement therapy: 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 lozenges. Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training | 0 | 36 | 0 | 36 | 14 | 36 |
| EG003 | Text Messaging + Mailed NRT | Mailed nicotine replacement therapy: 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 lozenges. Text messaging: 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: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training | 0 | 39 | 0 | 39 | 7 | 39 |
| Anxiety or agitation | Psychiatric disorders | Non-systematic Assessment |
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| mouth soreness | General disorders | Non-systematic Assessment |
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| sleep disturbance | Psychiatric disorders | Non-systematic Assessment |
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| lightheadedness | General disorders | Non-systematic Assessment |
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| skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| bloating | Gastrointestinal disorders | Non-systematic Assessment |
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| headache | Nervous system disorders | Non-systematic Assessment |
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| General disorders | Non-systematic Assessment | Patient reported general side effect, not specified |
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