Comprehensive Chronic Care for Smoking Cessation

Not currently recruiting at 1 trial location

Overseen By Jessica Cook, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Cognitive impairment, 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 aims to determine if a new healthcare approach called Comprehensive Chronic Care (CCC) can help more people quit smoking compared to usual methods. Researchers seek to find out if CCC results in more individuals remaining smoke-free after 18 months and if it provides good value for the money. Participants will either receive standard care, which includes nicotine patches and a quit line referral, or CCC, which offers personalized support, even for those not ready to quit immediately. Ideal candidates for this trial are individuals who have smoked daily for the past month and visit a participating clinic. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future smoking cessation methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Comprehensive Chronic Care (CCC) helps people quit smoking by providing ongoing support and information. Although specific safety data for CCC is unavailable, it includes personalized treatments proven effective for smoking cessation. These treatments often involve counseling and sometimes medications.

No specific reports of negative effects from CCC itself exist. However, treatments commonly used to help people stop smoking, like counseling, are generally safe. Some medications for quitting smoking, such as varenicline and bupropion, work well but can have side effects. Discuss any concerns with the trial team or a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Comprehensive Chronic Care approach for smoking cessation because it offers proactive, personalized support that isn't commonly found in standard care options. Unlike typical treatments that usually involve a one-time offer of nicotine patches and a referral to a quit line, this method provides ongoing outreach and tailored treatment plans. It specifically caters to individuals in various stages of quitting, whether they're considering reducing smoking, ready to quit, or trying again after a failed attempt. This personalized and continuous support system could significantly improve long-term success rates in quitting smoking.

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

Research has shown that Comprehensive Chronic Care (CCC), a treatment option in this trial, can significantly aid smoking cessation. One study found that the number of people who quit smoking increased from 1.3% to 8.7% after using a similar program, demonstrating its effectiveness. Another study discovered that various methods within CCC resulted in quit rates ranging from 4.2% to 15.1%, depending on the level of support and resources provided. These findings suggest that CCC assists individuals in quitting smoking by offering ongoing support and personalized treatment. Overall, CCC appears to be a promising approach to help people stop smoking and remain smoke-free. ^{1 2 6 7 8}

Who Is on the Research Team?

Jessica Cook, PhD

Principal Investigator

UW Center of Tobacco Research and Intervention

Are You a Good Fit for This Trial?

This trial is for English-speaking primary care patients who are current daily smokers, listed on a smoking registry at a participating clinic or reported smoking during a clinic visit. They must understand the study and consent to participate. Those with cognitive impairments that prevent informed consent cannot join.

Inclusion Criteria

Able to speak and read English.

I understand the study and agree to participate.

On smoking registry at a participating clinic OR report current smoking at a clinic visit

Exclusion Criteria

I have someone legally designated to make healthcare decisions for me, or I am not able to understand and give consent due to cognitive impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Comprehensive Chronic Care (CCC) or Standard Care (SC) for smoking cessation

18 months

Ongoing proactive outreach and annual offer of cessation treatment

Follow-up

Participants are monitored for smoking abstinence and treatment use

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Chronic Care
• Standard Care

Trial Overview The Breathe 2 Project 3 compares Comprehensive Chronic Care (CCC), an approach aimed at increasing engagement in smoking treatment and abstinence, against Standard Care (SC). The study focuses on abstinence rates after 18 months, reach of treatment, and cost-effectiveness.

How Is the Trial Designed?

Group I: Comprehensive Chronic Care Experimental Treatment 1 Intervention

ongoing proactive outreach designed to provide support and information about evidence-based smoking treatment, with access to individually validated treatments that are appropriate for patients who are: 1) unwilling quit but willing to reduce; 2) ready to quit; and 3) recovering from an unsuccessful quit attempt

Group II: Standard Care Active Control 1 Intervention

involves one offer of cessation treatment (8 weeks of nicotine patch plus referral to the tobacco quit line), annually

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+

Published Research Related to This Trial

Participants who chose varenicline (3,116 individuals) for tobacco cessation had higher abstinence rates at both 3 months (22%) and 6 months (17%) compared to those using nicotine replacement therapy (NRT) (13% at 3 months and 11% at 6 months), indicating that varenicline may be more effective in supporting quitting.

The study found that factors such as increasing age, having health insurance, and the number of counseling sessions were associated with higher rates of abstinence, particularly at 3 months, suggesting that these factors could enhance the effectiveness of quitline services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. Biazzo, LL., Froshaug, DB., Harwell, TS., et al.[2015]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

In a study involving 1251 adult smokers, combining varenicline with a nicotine patch or extending varenicline treatment from 12 to 24 weeks did not significantly improve smoking cessation rates after 52 weeks.

The primary outcome of 7-day point prevalence abstinence was similar across all treatment groups, indicating that neither combination therapy nor longer treatment duration provided additional benefits for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. Baker, TB., Piper, ME., Smith, SS., et al.[2022]

In a review of ten randomized controlled trials involving 3091 participants, varenicline did not show a significant increase in overall psychiatric disorders compared to placebo, with an incidence of 10.7% in the varenicline group versus 9.7% in the placebo group.

While varenicline was associated with a higher incidence of sleep disorders, there were no reported cases of suicidal ideation or behavior in the analyzed studies, suggesting that varenicline is generally safe for smokers without current psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. Tonstad, S., Davies, S., Flammer, M., et al.[2022]

In a study of 338 smokers using varenicline for smoking cessation, 45.9% reported at least one adverse event, with a notably higher incidence in women (51.5%) compared to men (40.5%).

The study identified 32 unexpected adverse events, including 19 psychiatric issues, raising concerns about the tolerability of varenicline and suggesting the need for further research on its safety profile and potential dosage adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tolerability profile of varenicline in current medical practice]. Dupont, P., Gillet, C., Guerin, M., et al.[2016]

In a randomized controlled trial, varenicline (Chantix) demonstrated a higher abstinence rate from smoking after one year compared to both bupropion SR (Zyban) and a placebo, indicating its efficacy in treating tobacco dependence.

Despite its effectiveness, varenicline has been associated with serious neuropsychiatric side effects, highlighting the importance of discussing potential risks and benefits with patients considering this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). Rankin, KV., Jones, DL.[2015]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

In a study of 47 daily smokers, those taking varenicline showed slower relapse rates and higher total abstinence after experiencing a programmed smoking lapse compared to those on a placebo.

Varenicline appears to reduce the perceived reward and effects of smoking, which may help prevent relapse during quit attempts, highlighting its effectiveness as a smoking cessation aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of varenicline on abstinence and smoking reward following a programmed lapse. McClure, EA., Vandrey, RG., Johnson, MW., et al.[2021]

In a study of 50 veterans using varenicline for smoking cessation, only 30% successfully quit smoking, which is lower than the 44% success rate reported in premarketing studies.

The study found a significant association between underlying psychiatric disorders and treatment failure, with all patients who discontinued due to adverse drug events related to mood changes having a history of mental illness, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness. Purvis, TL., Mambourg, SE., Balvanz, TM., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218422/

Evaluating the Impact of Chronic Care Model on Smoking ... Results: The CCM is expected to have contributed to a substantial decrease in the smoking rate among primary healthcare workers. It is also seen ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05382221

Breathe 2 Project 3: Comprehensive Chronic Care This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence ...

3. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

4. ajpmonline.org ajpmonline.org/article/S0749-3797(23)00411-7/abstract

Cost-Effectiveness of a Comprehensive Primary Care ... Smoking cessation rates increased from 1.3% pre-implementation to 8.7% post-implementation, for an incremental effectiveness of 7.4%. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732762/

Outcomes of a Comprehensive Mobile Smoking Cessation ... At 3 months, Average Treatment Effects weighted abstinence rates were 4.2% for those who did not use the web-based community, 15.1% for those ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0288759

Incidence of chronic disease following smoking cessation ... We conclude that accessing primary-care based smoking cessation treatment is associated with increased incidence of diabetes for both sexes, and chronic ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.115.002458

Efficacy and Safety of Smoking Cessation Interventions in ... Our meta-analysis suggests varenicline and bupropion, as well as individual and telephone counseling, are efficacious for smoking cessation in CVD patients.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10370896/

Incidence of chronic disease following smoking cessation ... Incidence of chronic disease following smoking cessation treatment: A matched cohort study using linked administrative healthcare data in Ontario, Canada