Therapy and Varenicline for Tobacco Use

Recruiting at 1 trial location

Overseen By Yu Chen, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Varenicline

Disqualifiers: Neuropsychiatric, Pregnancy, Nursing, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

114 Participants Needed

Trial Summary

What is the purpose of this trial?

The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have medical conditions that are contraindicated (not recommended) for fMRI, varenicline, or behavioral treatment, you may not be eligible to participate.

What data supports the effectiveness of the drug Varenicline for tobacco use?

Research shows that Varenicline is more effective than nicotine replacement therapy (NRT) in helping people quit smoking, especially when combined with behavioral support. It has been shown to be effective in people with and without psychiatric disorders. ^{1 2 3 4 5}

Is varenicline safe for use in humans?

Varenicline has been shown to be generally safe for helping people quit smoking, including those with heart or lung conditions. However, there have been reports of mood changes and heart-related issues, so it's important to discuss these risks with a doctor. ^{6 7 8 9 10}

How does the drug varenicline differ from other smoking cessation treatments?

Varenicline is unique because it targets specific receptors in the brain to reduce cravings and withdrawal symptoms while also blocking the rewarding effects of smoking. It has shown higher success rates in helping people quit smoking compared to other treatments like nicotine patches or bupropion. ^{1 6 11 12 13}

Research Team

Chiang-Shan Li

Principal Investigator

Yale University

Lisa Fucito, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adult smokers who have been using tobacco heavily for over a year, including e-cigarettes, and are not currently pregnant or nursing. Participants must speak English, have an optimal body mass index, and not be enrolled in other treatments. They should not have neuropsychiatric conditions or other factors that cause poor sleep which could affect the study.

Inclusion Criteria

Meet biochemical cut off for recent cigarette smoking or e-cigarette use

English literate

Optimal body mass index

Exclusion Criteria

Currently enrolled in other treatments

I am not pregnant or nursing.

Neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varenicline and attend weekly individual counseling sessions, with a target quit date at Week 4

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for smoking status and sleep disturbances at multiple intervals post-treatment

18 weeks

Follow-ups at week 8, 12, and 26

Treatment Details

Interventions

• Experimental health intervention
• Varenicline

Trial Overview The study tests if behavioral interventions can help adult smokers quit by reducing negative emotions and boosting self-control. It also looks to identify brain activity markers of these effects. The intervention includes Varenicline medication alongside experimental health strategies.

Participant Groups

Group I: Experimental health intervention Experimental Treatment 2 Interventions

Experimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks

Group II: Control health intervention Active Control 1 Intervention

Control health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Combining pharmacotherapy with nonpharmacological interventions is the most effective way to help smokers quit, highlighting the importance of a comprehensive approach to smoking cessation.

Among the pharmacotherapies, nicotine replacement therapy (NRT), bupropion, and varenicline have shown efficacy, with varenicline being the newest option and receiving special attention for its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco smoking cessation management: integrating varenicline in current practice. Galanti, LM.[2021]

Varenicline is an effective treatment for tobacco addiction, showing improved quit rates compared to other therapies, and is safe for use in both healthy smokers and those with cardiovascular or pulmonary issues, as well as smokeless tobacco users.

While varenicline is generally well-tolerated, there have been concerns about potential neuropsychiatric side effects, leading to updated monitoring guidelines, although most studies did not find a significant link to serious psychiatric symptoms, except for sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline in smoking cessation. Tonstad, S., Rollema, H.[2017]

A systematic review of 14 randomized controlled trials involving 8216 participants found that varenicline, a smoking cessation drug, is associated with a significantly increased risk of serious cardiovascular events compared to placebo, with an odds ratio of 1.72.

The analysis indicates safety concerns regarding varenicline, as serious cardiovascular events occurred in 1.06% of users compared to 0.82% in the placebo group, suggesting that while varenicline is effective for smoking cessation, it may pose risks to heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. Singh, S., Loke, YK., Spangler, JG., et al.[2022]

References

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

Varenicline for smoking cessation and reduction in people with severe mental illnesses: systematic review and meta-analysis. [2022]

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

Tobacco smoking cessation management: integrating varenicline in current practice. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Factors moderating the relative effectiveness of varenicline and nicotine replacement therapy in clients using smoking cessation services. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of varenicline versus nicotine replacement therapy in patients with and without psychiatric disorders. [2022]

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

Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Varenicline in smoking cessation. [2017]

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

Varenicline for smoking cessation: a narrative review of efficacy, adverse effects, use in at-risk populations, and adherence. [2020]

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

Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Varenicline: mode of action, efficacy, safety and accumulated experience salient for clinical populations. [2021]

11. Spain pubmed.ncbi.nlm.nih.gov

[Cost effectiveness analysis of varenicline (Champix) for the treatment of smoking in Spain]. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

Varenicline: new treatment with efficacy in smoking cessation. [2017]

13. Japan pubmed.ncbi.nlm.nih.gov

[On oral medications, especially varenicline]. [2015]