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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining a specific therapy with the medication varenicline (a smoking cessation aid) can help adult smokers quit by reducing negative emotions and boosting self-control. Researchers aim to understand how these changes affect the brain. Participants will receive either the experimental therapy plus varenicline or a control intervention plus varenicline over an 8-week period. The trial seeks individuals who have heavily used tobacco, including e-cigarettes, for more than six months and can read English. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research has shown that varenicline is usually well-tolerated. One study found that people using varenicline were more likely to quit smoking than those taking a placebo, with no major safety issues identified. Some individuals who couldn't handle the regular dose did well on a lower dose, indicating that the treatment can be adjusted.

Regarding the new health program being tested, studies have found that similar programs can help more people quit smoking. Although specific safety information is not yet available, the trial's current stage suggests it has been safe in earlier tests. Participants should feel positive about these results and are encouraged to discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this experimental health intervention for tobacco use because it combines a new approach with varenicline, a well-known smoking cessation aid. Unlike standard treatments that primarily rely on medications or behavioral therapy alone, this intervention integrates both, starting four weeks before and continuing four weeks after the target quit date. This dual approach aims to enhance the chances of quitting by addressing both the physical and behavioral aspects of tobacco addiction. The combination of these strategies could potentially lead to more effective and sustained smoking cessation outcomes.

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

Research has shown that combining behavioral techniques with medication greatly improves the chances of quitting smoking. In this trial, participants will receive either an experimental health intervention or a control health intervention, both combined with Varenicline. Studies have found that digital tools, such as personalized apps, can triple the success rates for younger adults trying to quit. These tools help reduce nicotine cravings and boost motivation to stop smoking. Varenicline effectively aids smoking cessation, achieving higher success rates than other medications. Combining these methods offers a promising way to support smokers in their journey to quit. ^{2 6 7 8 9}

Who Is on the Research Team?

Chiang-Shan Li

Principal Investigator

Yale University

Lisa Fucito, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12127979/

Effectiveness of Digital Intervention for Tobacco Cessation ... Outcomes indicate the effectiveness of the text message intervention program in promoting vaping cessation among young adult e- cigarette users, ...

2. nature.com nature.com/articles/s41562-025-02295-2

Efficacy of digital interventions for smoking cessation by ... In younger adults, personalized apps markedly improved quit rates (RR 3.37, 95% CI 1.76–6.47), despite wide CIs suggesting uncertainty.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876201823000011

Effectiveness of personalized tobacco cessation ... Reduction in nicotine dependence and tobacco craving, an increase in motivation level, quit attempts and clinical improvement favored the intervention group.

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00589-8/fulltext

Efficacy of e-health interventions for smoking cessation ... The meta-analysis revealed that compared to traditional smoking cessation interventions, e-health interventions can increase point quit rates.

5. aafp.org aafp.org/pubs/afp/issues/2022/1100/smoking-cessation-interventions.html

Smoking Cessation Interventions Clinical studies have demonstrated that combining pharmacotherapy with effective behavior strategies is significantly more effective than either approach alone.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555596/

Interventions for Smoking Cessation and Treatments ... - NCBI Among program completers (24% of the total sample), quit rates were 33% for 7-day point prevalence and 28% for 30-day point prevalence, and 88% of participants ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/13/12/e068629

Clinical impacts of an integrated electronic health record ... Following the implementation of the discharge intervention, there was a small increase in patient-reported quit rates (ITS estimate 5.0%, 95% CI 2.2% to 7.8%).

8. mhealth.jmir.org mhealth.jmir.org/2023/1/e46155

Feasibility, Acceptability, and Potential Impact of a Novel ... This study aims to assess the feasibility, acceptability, and potential impact of a novel mHealth app for smokers who want to quit smoking someday but are ...

9. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/The-effectiveness-of-tobacco-cessation-programs-for-university-students-A-systematic,162001,0,2.html

The effectiveness of tobacco cessation programs for ... Eight-week prolonged abstinence was reported by 203 participants (25.9%) in the intervention group and 105 (14.6%) in the control group. 4-week ...