Comprehensive Chronic Care for Smoking Cessation

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

425 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug varenicline for smoking cessation?

Research shows that varenicline (Chantix) is effective in helping people quit smoking, with higher success rates compared to other treatments like bupropion (Zyban) and placebo. It reduces withdrawal symptoms and cravings, making it easier for smokers to quit and stay smoke-free. ^{1 2 3 4 5}

Is the smoking cessation treatment using varenicline (Chantix) safe for humans?

Varenicline, also known as Chantix, has been associated with serious neuropsychiatric side effects, including depression and suicidal thoughts, as well as concerns about seizures and interactions with alcohol. While it is effective for quitting smoking, these potential risks should be carefully considered and discussed with a healthcare provider. ^{4 6 7 8 9}

How is the drug varenicline unique for smoking cessation?

Varenicline (also known as Chantix) is unique because it not only reduces nicotine withdrawal symptoms and cravings but also decreases the satisfaction from smoking, making it more effective than some other treatments like bupropion. Additionally, combining it with a nicotine patch or extending its use can further improve its effectiveness. ^{4 9 10 11 12}

Research Team

Jessica Cook, PhD

Principal Investigator

UW Center of Tobacco Research and Intervention

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Varenicline for smoking cessation intervention in chronic obstructive pulmonary disease. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Effects of varenicline on abstinence and smoking reward following a programmed lapse. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). [2015]

5. England pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

[Tolerability profile of varenicline in current medical practice]. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Enhancing the effectiveness of smoking treatment research: conceptual bases and progress. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Evaluation of varenicline as an aid to smoking cessation in UK general practice - a THIN database study. [2022]