Tobacco Use CessationPhase 4NCT04020718
Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
A Phase 4 study testing Brief telephone advice plus tailored text messages, Mailed nicotine replacement therapy and Proactive telephone coaching in people with Tobacco Use Cessation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Brief telephone advice plus tailored text messages, Mailed nicotine replacement therapy and Proactive telephone coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 30 Nov 2020
- 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 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 12Show fewer
- Weight < 100 pounds
- Unstable coronary disease
- Unstable arrhythmia
- Dementia or active psychosis or schizoaffective disorder
- Willing and able to receive and participate with a text message program for up to 12 weeks
- Unable to read English or unable to write English
Trial locations and contacts
1 site in 1 country.
United States1 site
Massacusetts General Hospital
Boston, Massachusetts, 02114
About this study
This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.
- Conditions
- Tobacco Use Cessation
- Being tested
- Brief telephone advice plus tailored text messages, Mailed nicotine replacement therapy, Proactive telephone coaching
- Keywords
- mobile health
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief telephone advice plus tailored text messagesBehavioural
All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.
Mailed nicotine replacement therapyDrug
Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).
Proactive telephone coachingBehavioural
Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.
| Study group | Role | What they receive |
|---|---|---|
| Early assessment | Experimental | Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching. Receives: Behavioral: Brief telephone advice plus tailored text messages; Drug: Mailed nicotine replacement therapy; Behavioral: Proactive telephone coaching |
| Late assessment | Experimental | Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching. Receives: Behavioral: Brief telephone advice plus tailored text messages; Drug: Mailed nicotine replacement therapy; Behavioral: Proactive telephone coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"
Measured: 12 weeks post-randomization
Secondary outcomes (4)
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks
7-day point prevalence abstinence (0, abstinent; 1, smoking)
Measured: 8 weeks post-randomization
Exhaled Carbon Monoxide Less Than 8 Parts Per Million
Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment
Measured: 12 weeks post-randomization
Self-reported Number of Days Nicotine Lozenge and/or Patch Used
Number of days when patch and/or lozenge was used
Measured: 12 weeks post-randomization
Self-reported Change in Average Number of Cigarettes Smoked Per Day
Self-reported change in average cigarettes smoked per day
Measured: 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start31 Jan 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Model description
- Pilot sequential multiple assignment randomized trial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gina Kruse, Massachusetts General Hospital
- Investigators
- Gina R Kruse, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020718
- Sponsor's protocol ID
- 2019A005710
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2019
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kruse GR, Joyce A, Yu L, Park ER, Neil J, Chang Y, Rigotti NA. A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke. J Subst Use Addict Treat. 2023 Feb;145:208930. doi: 10.1016/j.josat.2022.208930. Epub 2023 Jan 6.
PubMed 36880910
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
- ClinicalTrials.gov ID
- NCT04020718
- Acronym / sponsor ID
- 2019A005710
- Conditions
- Tobacco Use Cessation
- Keywords
- mobile health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Posted 10 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot sequential multiple assignment randomized trial
| Arm | Type | Receives |
|---|---|---|
| Early assessment | Experimental | Behavioral: Brief telephone advice plus tailored text messages, Drug: Mailed nicotine replacement therapy, Behavioral: Proactive telephone coachingPatients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching. |
| Late assessment | Experimental | Behavioral: Brief telephone advice plus tailored text messages, Drug: Mailed nicotine replacement therapy, Behavioral: Proactive telephone coachingPatients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief telephone advice plus tailored text messagesAll patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources. | Behavioural | Early assessment, Late assessment |
| Mailed nicotine replacement therapyPatients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). | Drug | Early assessment, Late assessment |
| Proactive telephone coachingPatients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities. | Behavioural | Early assessment, Late assessment |
Primary outcome
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
Time frame: 12 weeks post-randomization
7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"
4 secondary outcomes
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks
Time frame: 8 weeks post-randomization
Exhaled Carbon Monoxide Less Than 8 Parts Per Million
Time frame: 12 weeks post-randomization
Self-reported Number of Days Nicotine Lozenge and/or Patch Used
Time frame: 12 weeks post-randomization
Self-reported Change in Average Number of Cigarettes Smoked Per Day
Time frame: 12 weeks post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36880910Kruse GR, Joyce A, Yu L, Park ER, Neil J, Chang Y, Rigotti NA. A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke. J Subst Use Addict Treat. 2023 Feb;145:208930. doi: 10.1016/j.josat.2022.208930. Epub 2023 Jan 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina R Kruse, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brief telephone advice plus tailored text messages, Mailed nicotine replacement therapy and Proactive telephone coaching in people with Tobacco Use 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 12 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 10 Mar 2022. 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 10 Mar 2022). 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?
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks (time frame: 12 weeks post-randomization). 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 NCT04020718, which also lists 1 linked publication.
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 10 Mar 2022.