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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

502 Participants Needed

Trial Summary

What is the purpose of this trial?

This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: use of cessation treatment and smoking abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.

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.

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

Research shows that varenicline is an effective aid for quitting smoking, with higher success rates compared to placebo and other treatments like bupropion and nicotine replacement therapy. It helps reduce cravings and withdrawal symptoms, making it easier for people to quit smoking. ^{1 2 3 4 5}

How is the drug varenicline unique for smoking cessation?

Varenicline (Chantix) is unique for smoking cessation because it specifically targets nicotine receptors in the brain to reduce cravings and withdrawal symptoms, making it more effective than other options like nicotine replacement therapy or bupropion. However, it is important to monitor for potential neuropsychiatric side effects and interactions with alcohol. ^{2 4 6 7 8}

Research Team

Jessica Megan Cook, PhD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Varenicline: a review of its use as an aid to smoking cessation therapy. [2018]

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

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]

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

Varenicline: a pharmacoeconomic review of its use as an aid to smoking cessation. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

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

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

6. Greece pubmed.ncbi.nlm.nih.gov

Pharmacist prescriber smoking cessation intervention during the COVID-19 pandemic. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

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

The use of varenicline to treat nicotine dependence among patients with cancer. [2022]