Enhanced Support vs Standard Advice for Smoking Cessation in Veterans

Overseen By Jessica M Cook, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Smoking cessation drugs

Disqualifiers: Non-cigarette tobacco, Incarceration, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help Veterans quit smoking: Enhanced Chronic Care and Standard Care. Enhanced Chronic Care provides ongoing phone support and motivation, while Standard Care offers brief annual advice and may include medications like Varenicline (also known as Chantix, Apovarenicline, Champix, or Nocrav). The researchers aim to determine if Enhanced Chronic Care increases treatment use and smoking cessation among Veterans. Veterans who have smoked at least four cigarettes daily for six months and are not ready to quit soon might be suitable for this trial. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative support methods for quitting smoking.

Will I have to stop taking my current medications?

The trial requires that you stop using any current medications for smoking cessation that are not provided by the researchers during the study.

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

Research has shown that programs like Enhanced Chronic Care, which offer ongoing support and motivation, have been well-received. For instance, a study on social support for veterans trying to quit smoking found these methods safe and effective. No major negative side effects were reported, suggesting this type of care is safe for most people.

Enhanced Chronic Care provides continuous support and access to treatments to help people quit smoking. These programs have been used without major safety issues, especially when designed for veterans. While consulting a healthcare provider is always important, past research suggests that Enhanced Chronic Care is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Chronic Care approach for smoking cessation because it offers ongoing, personalized support rather than just a one-time conversation. Unlike standard care, which typically involves brief annual advice over the phone, this method provides continuous motivational interventions and interpersonal support. This proactive strategy promotes a readiness to quit by giving veterans easier access to proven smoking treatments, potentially leading to higher success rates in quitting smoking long-term.

What evidence suggests that Enhanced Chronic Care is effective for smoking cessation in Veterans?

Research has shown that Enhanced Chronic Care, a treatment option in this trial, helps Veterans quit smoking more effectively than standard methods. In one study, more Veterans in the enhanced care group used stop-smoking medications, with 57.1% using them compared to those in the standard care group. Another study found that after six months, 14% of people in the proactive care group had quit smoking, compared to 11% in the usual care group. These findings suggest that ongoing support and motivation greatly improve quitting success. Enhanced Chronic Care offers a real advantage by keeping participants engaged and ready to quit. ^{2 6 7 8 9}

Who Is on the Research Team?

Jessica Megan Cook, PhD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Are You a Good Fit for This Trial?

This trial is for Veterans who smoke at least 4 cigarettes daily for the past six months, are not ready to quit within the next month, and can consent to participate. It's open to those over 18 who speak English and are medically cleared for nicotine replacement therapy if needed. Women must use birth control during the study.

Inclusion Criteria

I am cleared by a doctor to use nicotine replacement therapy.

Agree to participate in the study

Be a Veteran

Exclusion Criteria

You are currently using a smoking cessation medication that was not prescribed by the study team.

Incarceration

You primarily use tobacco products other than cigarettes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Enhanced Chronic Care or Standard Care for smoking cessation over a 2-year period

2 years

Ongoing phone-based interventions

Follow-up

Participants are monitored for smoking abstinence and treatment use after the intervention period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Chronic Care
• Standard Care

Trial Overview

The trial compares Enhanced Chronic Care—a motivational support system designed to increase readiness to stop smoking—with Standard Care, which involves brief yearly advice. The goal is to see if Enhanced Chronic Care boosts treatment usage and helps participants quit smoking more effectively than Standard Care.

How Is the Trial Designed?

Group I: Enhanced Chronic Care Experimental Treatment 1 Intervention

Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.

Group II: Standard Care Active Control 1 Intervention

Standard Care provides phone-based brief advice to quit once per year.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

Varenicline is an effective smoking cessation aid, showing significantly higher continuous abstinence rates compared to placebo, bupropion, and nicotine replacement therapy during the last 4 weeks of treatment, and it also helps reduce cravings and withdrawal symptoms.

The treatment is generally well tolerated, with nausea being the most common side effect that diminishes over time; however, further research is needed on potential neuropsychiatric events associated with its use. Additionally, varenicline is considered cost-effective compared to other smoking cessation methods, with analyses showing it dominates bupropion and nicotine replacement therapy in terms of cost per quality-adjusted life year (QALY) gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline: a pharmacoeconomic review of its use as an aid to smoking cessation. Keating, GM., Lyseng-Williamson, KA.[2021]

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]

Varenicline, an FDA-approved medication for smoking cessation, significantly increases the chances of quitting smoking, with continuous abstinence rates 2.7 to 3.1 times higher than placebo over a 52-week period after 12 weeks of treatment.

In addition to helping smokers quit, varenicline reduces cravings and withdrawal symptoms, making it a valuable option for those looking to stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline: a review of its use as an aid to smoking cessation therapy. Keating, GM., Siddiqui, MA.[2018]

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]

Varenicline is the most effective first-line pharmacotherapy for smoking cessation, showing a significant effect compared to placebo with an odds ratio of 2.27, followed by bupropion (1.69) and nicotine replacement therapy (1.60).

Despite some safety concerns, regulatory agencies deem bupropion and varenicline to have a favorable benefit/risk profile, but healthcare providers should monitor patients for potential neuropsychiatric symptoms, especially in those with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. Aubin, HJ., Luquiens, A., Berlin, I.[2022]

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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 ...