Quitting SmokingPhase 4NCT05683821
BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study
A Phase 4 study testing Text message smoking treatment, Nicotine replacement therapy sampling and Wisconsin Tobacco QuitLine Referral in people with Quitting Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quitting Smoking, Smoking Cessation, Smoking, Cigarette
- What is being tested?
- Text message smoking treatment, Nicotine replacement therapy sampling and Wisconsin Tobacco QuitLine Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,376 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 7 May 2025
- 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
- Adult age 18 years or older
- Meet criteria for inclusion on a smoking registry (based on current smoking status and/or recent diagnosis of nicotine dependence or treatment of nicotine dependence)
- Being seen in a participating clinic in the past 1-3 years, as documented in the EHR
- Having a valid address
- Not having a language other than English listed as preferred language
Who cannot join
- Invalid address
- Participant opted out of the study within 18 months of initial outreach letter (or were opted out of the study by a legally authorized representative or an activated power of attorney for health care)
- Participant clarification that they did not meet criteria for the smoking registry at the time of initial outreach
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments
The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when compared against a standard outreach approach. Only patients at participating adult primary care clinics will be eligible for the study. Five clinic sites will be randomized to an enhanced outreach approach, while another 5 will be randomly assigned to standard smoking treatment outreach. Eligible patients at these clinics will be in this study for up to 18 months.
Read the detailed description
This 2-arm cluster-randomized clinical trial will compare a standard approach to smoking cessation treatment outreach in adult primary care to an enhanced approach offering more frequent outreach, multiple ways to request treatment, and a broader array of treatment options.
The researchers hypothesize that enhanced outreach comprising quarterly messages offering both standard, person-to-person treatment options (quitline services, care from a primary care provider, phone coaching and medication through a clinical trial) and self-guided treatment options (nicotine replacement therapy sampling (2 week supplies of nicotine replacement therapies and/or enrollment in text-message based cessation support via Smokefree.gov text-message programs) will attract more adult primary care patients who smoke to treatment, and will help more participants achieve abstinence from smoking, as indicated by a change in their smoking status from current to former smoking in their electronic health records. The comparison condition is a standard outreach approach comprising a mailed letter informing participants of person-to-person treatment options (quitline services, care from a primary care provider, and/or phone coaching and medication through a clinical trial).
Up to 12,000 adult participants who receive primary care at 10 participating clinic sites and whose electronic health records suggest they smoke will receive smoking cessation treatment outreach for up to 18 months, unless they opt out of participation. Randomization will occur at the clinic site level rather than at the participant level, and an opt-out approach to recruitment will be adopted.
- Conditions
- Quitting Smoking, Smoking Cessation, Smoking, Cigarette
- Being tested
- Text message smoking treatment, Nicotine replacement therapy sampling, Wisconsin Tobacco QuitLine Referral, Referral to Primary Care Provider, BREATHE 2 Cessation Study
- Medical subject headings
- Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message smoking treatmentBehavioural
Facilitated enrollment in an NCI-sponsored text messaging program:
- SmokefreeTXT (if ready to set a quit date in the next 14 days)
- Practice Quit (if ready to practice quitting 1-5 days but not ready to quit permanently)
- Daily Challenges (if not ready to quit, but willing to make some changes)
Nicotine replacement therapy samplingDrug
Also called Nicoderm, Nicorette
Participants may request:
- Nicotine patches that release nicotine slowly over 24 hours, in either 7 mg, 14 mg, or 21 mg doses
- Nicotine gum or lozenges that release medication quickly and can be used every 1-2 hours to prevent and cope with cravings to smoke, in either 2 mg or 4 mg doses
Wisconsin Tobacco QuitLine ReferralCombination product
Patients will be offered referral to the Wisconsin Tobacco QuitLine that offers phone counseling and nicotine replacement starter kits (2 week supplies) to people ready to quit smoking, in addition to web-based, text messaging, and mailed support, at no cost to Wisconsin residents.
Referral to Primary Care ProviderCombination product
Patients who want to talk to their Primary Care Providers about quitting smoking will be encouraged to make an appointment with their provider to receive smoking cessation counseling and to discuss pharmacotherapy options.
BREATHE 2 Cessation StudyCombination product
Patients who are interested in participating in a separate randomized controlled trial of smoking cessation treatment will be invited to learn about and complete an eligibility screening and consent process for the trial. Those who enter the study receive both counseling and pharmacotherapy.
Additional modalities to learn about and request treatmentBehavioural
Participants in Enhanced Outreach arm clinics will have the option to request e-mail and/or text message communication regarding their smoking treatment options, and to initiate treatment via phone or online survey.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced outreach | Experimental | Quarterly outreach via letter and applicable patient-preferred modalities, including e-mail and/or text messaging, offering both standard person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and self-guided, remote treatment options (mailed nicotine replacement therapy samples and/or facilitated enrollment in a Smokefree.gov texting program). Patients in clinics assigned to this arm will also have the option to initiate treatment by phone or online. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic. Receives: Behavioral: Text message smoking treatment; Drug: Nicotine replacement therapy sampling; Combination Product: Wisconsin Tobacco QuitLine Referral; Combination Product: Referral to Primary Care Provider; Combination Product: BREATHE 2 Cessation Study; Behavioral: Additional modalities to learn about and request treatment |
| Standard outreach | Active comparator | One mailed letter at study initiation outlining available person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and how to initiate treatment by phone. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic. Receives: Combination Product: Wisconsin Tobacco QuitLine Referral; Combination Product: Referral to Primary Care Provider; Combination Product: BREATHE 2 Cessation Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Treatment Initiation Within 12 Months of Enrollment
The proportion of study participants who initiate smoking treatment, as recorded in the electronic health record. Rates of smoking treatment initiation will be compared in the Enhanced Outreach and Standard Outreach arms.
Measured: Up to 12 months
Secondary outcomes (4)
Smoking Treatment Initiation Within 18 Months of Enrollment
The proportion of study participants who initiate smoking treatment, as recorded in the electronic health record. Rates of smoking treatment initiation will be compared in the Enhanced Outreach and Standard Outreach arms.
Measured: Up to 18 months
Conversion From Current Smoking to Former Smoking
Quitting smoking as indicated by a change in smoking status from current to former smoking, as recorded in the electronic health record.
Measured: 12 and 18 months after study enrollment
Cost Per Quit Attempt
Estimated costs per assisted quit attempt initiated were computed. Total costs were computed as the sum of costs of outreach materials, digital outreach, and mailings; tobacco quitline counseling; nicotine medications ordered for patients; smoking cessation counseling provided by healthcare providers; text message support programs; and treatment navigation support. Costs were calculated based on prices or reimbursement rates as of May 6, 2025 for each outreach or treatment component, multiplied by the volume of patients who received each component within study arms. Cost per quit attempt was computed by dividing total costs by the number of patients who entered treatment to quit within each arm.
Measured: Up to 18 months
Cost Per Quit
Estimated costs per successful quit attempt (conversion to former smoking status) were computed. Total costs were computed as the sum of costs of outreach materials, digital outreach, and mailings; tobacco quitline counseling; nicotine medications ordered for patients; smoking cessation counseling provided by healthcare providers; text message support programs; and treatment navigation support. Costs were calculated based on prices or reimbursement rates as of May 6, 2025 for each outreach or treatment component, multiplied by the volume of patients who received each component within study arms. Cost per quit was computed by dividing total costs by the number of patients who converted from current to former smoking within each arm.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start24 Jul 2023
- Primary completion7 May 2025
- Study completion7 May 2025
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.
- Other trials for Quitting SmokingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Parallel groups
- Model description
- Cluster-randomized controlled
- Masking
- None (open label)
- Enrolment
- 12,376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Danielle E McCarthy, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683821
- Sponsor's protocol ID
- 2022-0973
- Other IDs
- 2P01CA180945-06, A534253, SMPH/MEDICINE/GEN INT MD, Protocol Version 07/11/2022
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2023
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data for this study will be extracted from electronic health records at health systems participating in this research. These data belong to the health systems and not to the research team. As such, individual participant data will not be available to other researchers until and unless the participating health systems authorize such sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments
- ClinicalTrials.gov ID
- NCT05683821
- Acronym / sponsor ID
- 2022-0973
- Conditions
- Quitting Smoking, Smoking Cessation, Smoking, Cigarette
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,376 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Posted 26 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when compared against a standard outreach approach. Only patients at participating adult primary care clinics will be eligible for the study. Five clinic sites will be randomized to an enhanced outreach approach, while another 5 will be randomly assigned to standard smoking treatment outreach. Eligible patients at these clinics will be in this study for up to 18 months.
Detailed description
This 2-arm cluster-randomized clinical trial will compare a standard approach to smoking cessation treatment outreach in adult primary care to an enhanced approach offering more frequent outreach, multiple ways to request treatment, and a broader array of treatment options.
The researchers hypothesize that enhanced outreach comprising quarterly messages offering both standard, person-to-person treatment options (quitline services, care from a primary care provider, phone coaching and medication through a clinical trial) and self-guided treatment options (nicotine replacement therapy sampling (2 week supplies of nicotine replacement therapies and/or enrollment in text-message based cessation support via Smokefree.gov text-message programs) will attract more adult primary care patients who smoke to treatment, and will help more participants achieve abstinence from smoking, as indicated by a change in their smoking status from current to former smoking in their electronic health records. The comparison condition is a standard outreach approach comprising a mailed letter informing participants of person-to-person treatment options (quitline services, care from a primary care provider, and/or phone coaching and medication through a clinical trial).
Up to 12,000 adult participants who receive primary care at 10 participating clinic sites and whose electronic health records suggest they smoke will receive smoking cessation treatment outreach for up to 18 months, unless they opt out of participation. Randomization will occur at the clinic site level rather than at the participant level, and an opt-out approach to recruitment will be adopted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Enhanced outreach | Experimental | Behavioral: Text message smoking treatment, Drug: Nicotine replacement therapy sampling, Combination Product: Wisconsin Tobacco QuitLine Referral, Combination Product: Referral to Primary Care Provider, Combination Product: BREATHE 2 Cessation Study, Behavioral: Additional modalities to learn about and request treatmentQuarterly outreach via letter and applicable patient-preferred modalities, including e-mail and/or text messaging, offering both standard person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and self-guided, remote treatment options (mailed nicotine replacement therapy samples and/or facilitated enrollment in a Smokefree.gov texting program). Patients in clinics assigned to this arm will also have the option to initiate treatment by phone or online. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic. |
| Standard outreach | Active comparator | Combination Product: Wisconsin Tobacco QuitLine Referral, Combination Product: Referral to Primary Care Provider, Combination Product: BREATHE 2 Cessation StudyOne mailed letter at study initiation outlining available person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and how to initiate treatment by phone. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult age 18 years or older
- Meet criteria for inclusion on a smoking registry (based on current smoking status and/or recent diagnosis of nicotine dependence or treatment of nicotine dependence)
- Being seen in a participating clinic in the past 1-3 years, as documented in the EHR
- Having a valid address
- Not having a language other than English listed as preferred language
Key exclusion criteria (3 listed)
- Invalid address
- Participant opted out of the study within 18 months of initial outreach letter (or were opted out of the study by a legally authorized representative or an activated power of attorney for health care)
- Participant clarification that they did not meet criteria for the smoking registry at the time of initial outreach
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 |
|---|---|---|
| Text message smoking treatmentFacilitated enrollment in an NCI-sponsored text messaging program: * SmokefreeTXT (if ready to set a quit date in the next 14 days) * Practice Quit (if ready to practice quitting 1-5 days but not ready to quit permanently) * Daily Challenges (if not ready to quit, but willing to make some changes) | Behavioural | Enhanced outreach |
| Nicotine replacement therapy samplingAlso: Nicoderm, NicoretteParticipants may request: * Nicotine patches that release nicotine slowly over 24 hours, in either 7 mg, 14 mg, or 21 mg doses * Nicotine gum or lozenges that release medication quickly and can be used every 1-2 hours to prevent and cope with cravings to smoke, in either 2 mg or 4 mg doses | Drug | Enhanced outreach |
| Wisconsin Tobacco QuitLine ReferralPatients will be offered referral to the Wisconsin Tobacco QuitLine that offers phone counseling and nicotine replacement starter kits (2 week supplies) to people ready to quit smoking, in addition to web-based, text messaging, and mailed support, at no cost to Wisconsin residents. | Combination product | Enhanced outreach, Standard outreach |
| Referral to Primary Care ProviderPatients who want to talk to their Primary Care Providers about quitting smoking will be encouraged to make an appointment with their provider to receive smoking cessation counseling and to discuss pharmacotherapy options. | Combination product | Enhanced outreach, Standard outreach |
| BREATHE 2 Cessation StudyPatients who are interested in participating in a separate randomized controlled trial of smoking cessation treatment will be invited to learn about and complete an eligibility screening and consent process for the trial. Those who enter the study receive both counseling and pharmacotherapy. | Combination product | Enhanced outreach, Standard outreach |
| Additional modalities to learn about and request treatmentParticipants in Enhanced Outreach arm clinics will have the option to request e-mail and/or text message communication regarding their smoking treatment options, and to initiate treatment via phone or online survey. | Behavioural | Enhanced outreach |
Primary outcome
Smoking Treatment Initiation Within 12 Months of Enrollment
Time frame: Up to 12 months
The proportion of study participants who initiate smoking treatment, as recorded in the electronic health record. Rates of smoking treatment initiation will be compared in the Enhanced Outreach and Standard Outreach arms.
4 secondary outcomes
Smoking Treatment Initiation Within 18 Months of Enrollment
Time frame: Up to 18 months
Conversion From Current Smoking to Former Smoking
Time frame: 12 and 18 months after study enrollment
Cost Per Quit Attempt
Time frame: Up to 18 months
Cost Per Quit
Time frame: Up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data for this study will be extracted from electronic health records at health systems participating in this research. These data belong to the health systems and not to the research team. As such, individual participant data will not be available to other researchers until and unless the participating health systems authorize such sharing.
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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.
Danielle E McCarthy, PhD principal investigator
University of Wisconsin, Madison
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 Text message smoking treatment, Nicotine replacement therapy sampling and Wisconsin Tobacco QuitLine Referral in people with Quitting Smoking and Smoking Cessation, run by University of Wisconsin, Madison 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 5 inclusion and 3 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 26 Jun 2026. 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 26 Jun 2026). 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?
Smoking Treatment Initiation Within 12 Months of Enrollment (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.