Smoking Cessation Outreach Methods for Quitting Smoking

Overseen By Kari Giacalone, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Invalid address, Opted out, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people quit smoking by comparing different outreach strategies. It aims to determine if more frequent and varied communication, combined with additional treatment options like nicotine replacement therapy (which provides nicotine without smoking) and text message support, improves quitting success compared to standard methods. Individuals who have been smoking and recently visited a participating clinic may qualify for this study. The trial lasts up to 18 months and involves clinics using either the standard or enhanced outreach approach.

As an unphased trial, this study offers a unique opportunity to contribute to innovative smoking cessation strategies that could benefit many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these outreach methods are safe for smoking cessation?

Research has shown that nicotine replacement therapy (NRT) is generally safe for helping people quit smoking. It effectively reduces cravings for cigarettes and increases the chances of quitting. Some minor side effects, such as skin irritation from patches or slight irritation in the mouth from lozenges, might occur, but these are usually mild and short-lived.

Evidence suggests that text message smoking treatments can be a helpful tool in supporting quitting. While text messaging alone may not significantly increase quit rates, it serves as a useful addition to other treatments. This method poses no major safety concerns, as it primarily involves sending supportive messages to maintain motivation.

Overall, both treatments have a good safety record and can be useful aids in quitting smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smoking Cessation Outreach Methods because they offer a fresh approach to helping people quit smoking. Unlike traditional methods that typically focus on person-to-person counseling and referrals, this trial explores enhanced outreach with more frequent and varied communication like emails, texts, and mailed nicotine replacement samples. This approach allows for greater flexibility and personalization, catering to individual preferences and potentially increasing engagement. By integrating self-guided and remote treatment options, the trial aims to make quitting smoking more accessible and convenient, which could lead to higher success rates.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Research shows that nicotine replacement therapy (NRT), which participants in this trial may receive, can help people quit smoking. Studies have found that those who use NRT are more likely to attempt quitting and experience fewer cravings and withdrawal symptoms. This method has succeeded even for groups that usually find it harder to quit, such as people with lower incomes.

Text message treatments, another option in this trial, also show promise in helping people stop smoking. Research indicates that people who receive supportive text messages are more likely to quit than those who do not. These messages provide regular support and reminders, increasing the chances of quitting. Together, these methods offer several ways to make quitting smoking easier. ^{1 5 6 7 8}

Who Is on the Research Team?

Danielle E McCarthy, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

The BREATHE 2 study is for adults over 18 who smoke and have visited participating primary care clinics in the last 1-3 years. They must be on a smoking registry, speak English, and have a valid address. Those with invalid addresses or who opted out of the study are excluded.

Inclusion Criteria

Being seen in a participating clinic in the past 1-3 years, as documented in the EHR

My preferred language for medical care is English.

Meets criteria for inclusion on a smoking registry (based on current smoking status and/or recent diagnosis of nicotine dependence or treatment of nicotine dependence)

Exclusion Criteria

Invalid address

I chose to leave the study within 18 months of being contacted, or my legal representative did.

Participant clarification that they did not meet criteria for the smoking registry at the time of initial outreach

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive smoking cessation treatment outreach, including standard and enhanced outreach approaches

18 months

Quarterly outreach via letter, email, or text messaging

Follow-up

Participants are monitored for smoking cessation success and treatment initiation

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine replacement therapy sampling
• Text message smoking treatment

Trial Overview This trial tests if more frequent outreach, varied outreach methods (like texts), and multiple treatment options help smokers quit better than standard approaches. Participants will experience this at certain clinics for up to 18 months.

How Is the Trial Designed?

Group I: Enhanced outreach Experimental Treatment 6 Interventions

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.

Group II: Standard outreach Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7292788/

Results from a pragmatic cluster randomized clinical trial Cessation Related Outcomes & Changes in Smoking​​ As depicted in Table 2, smokers who received an NRT sample were more likely to make a quit attempt sooner, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38446860/

Impact of Nicotine Replacement Therapy Sampling on ... Results: The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived ...

3. academic.oup.com academic.oup.com/ntr/advance-article/doi/10.1093/ntr/ntaf022/8016067

Real-World Effectiveness of Nicotine Replacement Therapy ... The evidence presented suggests the real-world effectiveness of 1-week NRT sampling combined with counseling for increasing smoking abstinence and reduction ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743520301201

The differential impact of nicotine replacement therapy ... Results suggest that NRT sampling may be more effective among some of the most disadvantaged groups of smokers, including smokers with lower income and ...

5. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Effect-of-mobile-interventions-with-nicotine-replacement-ntherapy-sampling-on-long,160168,0,2.html

Effect of mobile interventions with nicotine replacement ... Nicotine replacement therapy sampling (NRT-S) has been used in unmotivated smokers and was found to be effective for increasing quit attempts ...

6. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Adverse-events-associated-with-nicotine-replacement-therapy-NRT-for-smoking-cessation,65973,0,2.html

Adverse events associated with nicotine replacement ... Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02148445

Smoking Cessation Versus Long-term Nicotine ... Long-term NRT is safe; it can reduce the rewarding effects of cigarettes, reduce the amount that people smoke, and increase quit rates. Long-term NRT has not, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772724621000184

A qualitative analysis of nicotine replacement therapy ... This study examines qualitative data collected as part of a research program to develop and pilot test a proactive smoking cessation intervention with text ...