Quitting Strategies + Varenicline for Smoking Cessation

Overseen By Madilyn Augustine

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must be taking: Varenicline

Must not be taking: Smoking cessation drugs

Disqualifiers: Pregnancy, Severe renal impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method to quit both cigarettes and e-cigarettes, either by stopping both simultaneously or by quitting cigarettes first and e-cigarettes later. Participants will receive varenicline, a medication that reduces cravings, along with counseling and resources such as booklets and text support. The trial seeks individuals who have smoked at least 5 cigarettes a day, used e-cigarettes regularly for the past three months, and are eager to quit both products soon. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to benefit from this approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using any smoking cessation services or FDA-approved smoking cessation medications.

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

Past studies have shown that varenicline helps people quit smoking by reducing cravings and blocking the enjoyable effects of smoking. Research indicates that those using varenicline are more likely to quit than those taking a placebo. Some users, however, have reported side effects like nausea and vivid dreams. The FDA has already approved varenicline for quitting smoking, suggesting it is generally safe.

Research shows that counseling plays a crucial role in quitting smoking. Both individual and group counseling have helped many people quit successfully by providing support and strategies to handle cravings and stress.

Guided Self-Change booklets serve as another tool to help people stop smoking. These booklets help individuals create personalized quit plans and stay committed to quitting. While specific safety data on the booklets is limited, they are generally considered safe as they provide information and encouragement.

Overall, the treatments in this trial, including varenicline, counseling, and self-help booklets, have been used safely in the past to help people quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore new strategies for quitting smoking by tackling both cigarettes and e-cigarettes. One approach focuses on quitting both simultaneously, which could help individuals break the habit entirely and more effectively. The other approach targets cigarettes first, then e-cigarettes, which might make the process feel more manageable for some. Both strategies incorporate varenicline, a medication known to help with smoking cessation, combined with counseling and self-help resources, offering a comprehensive support system that could enhance the success rate beyond current methods.

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

Research has shown that varenicline, which participants in this trial will receive, can help people quit smoking by reducing cravings and making cigarettes less enjoyable. One study found that 40% of people stopped smoking after 12 weeks of using varenicline, compared to just 8.3% who didn't use it. Counseling, another component of this trial, plays a crucial role by boosting confidence and readiness to quit. Participants will also have access to self-help booklets, which provide additional support through structured guidance over time and have been shown to increase quit rates. Together, these treatments offer a strong approach to quitting smoking and e-cigarettes, with one arm focusing on concurrent cessation and another on sequential cessation. ^{2 6 7 8 9}

Who Is on the Research Team?

Lisa Fucito, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults who have been smoking cigarettes and using e-cigarettes for at least 3 months, smoke 5+ cigarettes daily, use e-cigarettes on most days, and are ready to quit both within a month. It's not for pregnant or breastfeeding women, those unable to consent, people with severe kidney issues or unstable heart conditions, or users of other tobacco products more than once a week.

Inclusion Criteria

I am ready to quit smoking and using tobacco products within a month.

Smoke 5 or more cigarettes per day

English literate

Exclusion Criteria

Vulnerable Populations: Pregnant women, children, prisoners, or institutionalized individuals

I am unable to give my own consent for medical procedures.

Individuals using other tobacco or nicotine products besides cigarettes and e-cigarettes > once per week in the last 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial online screening and tele-video/phone call final screening

Treatment

Participants receive 12 weeks of varenicline, weekly individual counseling, and access to cessation resources for either concurrent or sequential cessation of cigarettes and e-cigarettes

12 weeks

Weekly individual counseling sessions

Follow-up

Participants are monitored for cigarette and e-cigarette abstinence and health-related biomarkers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• Guided Self-Change Booklets
• Varenicline

Trial Overview The study tests if quitting cigarettes and e-cigarettes together (QUIT-C) works better than stopping them one after the other. Participants will all receive Varenicline—a medication that reduces cravings and enjoyment from tobacco—alongside counseling and self-help resources.

How Is the Trial Designed?

Group I: QUIT-S (Sequential) Experimental Treatment 3 Interventions

Treatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation.

Group II: QUIT-C (Concurrent) Experimental Treatment 3 Interventions

Treatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 392 adult patients admitted for smoking-related illnesses, those who received varenicline tartrate along with Quitline-counselling had a significantly higher rate of continuous smoking abstinence (31.1%) compared to those who received counselling alone (21.4%).

The results suggest that initiating varenicline treatment in the inpatient setting, combined with counselling, is an effective strategy for promoting long-term smoking cessation, with benefits observed at a 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Termination Opportunity for inPatients (STOP): superiority of a course of varenicline tartrate plus counselling over counselling alone for smoking cessation: a 12-month randomised controlled trial for inpatients. Smith, BJ., Carson, KV., Brinn, MP., et al.[2015]

In a study of 1027 adult smokers, varenicline was found to be significantly more effective for smoking cessation than both placebo and bupropion SR, with 43.9% of participants abstinent during the last 4 weeks of treatment compared to 17.6% and 29.8% respectively.

Varenicline was generally safe and well-tolerated, with the most common side effect being nausea, affecting 29.4% of participants, and a discontinuation rate due to adverse events similar to that of bupropion SR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. Jorenby, DE., Hays, JT., Rigotti, NA., et al.[2023]

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]

In a study involving 392 adult patients with smoking-related illnesses, varenicline tartrate (VT) combined with quitline counseling was found to be well tolerated, with nausea being the most common side effect reported in 16.3% of the VT group.

VT demonstrated safety in the inpatient setting, with no significant increase in mortality compared to quitline counseling alone, suggesting it could be integrated into standard care for hospitalized smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of varenicline tartrate and counseling versus counseling alone for smoking cessation: a randomized controlled trial for inpatients (STOP study). Carson, KV., Smith, BJ., Brinn, MP., et al.[2018]

In a study of 604 patients receiving varenicline for smoking cessation, the quit rate was 36.5% for those receiving individual counseling from their general practitioner and 42.3% for those receiving intensive counseling, indicating a trend towards better outcomes with intensive support.

While no statistically significant difference in quit rates was found, satisfaction with the counseling process was higher in the general practitioner group (68% satisfied) compared to the intensive counseling group (64% satisfied), suggesting that individual counseling may be more positively received by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking quit rates among patients receiving pharmacotherapy who received general practitioner counselling versus intensive counselling: a retrospective cohort study. Yehoshua, I., Adler, L., Hermoni, SA., et al.[2023]

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]

In a study of 139 long-term nicotine replacement therapy users, varenicline combined with counseling significantly improved the quit rate at 12 weeks (64.3% for varenicline vs. 40.6% for placebo), indicating its efficacy in helping users stop NRT.

Participants taking varenicline experienced lower withdrawal symptoms compared to those on placebo, suggesting that varenicline not only aids in quitting but also makes the process more comfortable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Tønnesen, P., Mikkelsen, K.[2015]

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 study involving 140 daily electronic cigarette users, varenicline combined with counseling significantly increased the continuous abstinence rate from vaping compared to a placebo, with rates of 40.0% vs 20.0% during weeks 4-12.

The study also found that varenicline maintained higher rates of vaping abstinence at 34.3% compared to 17.2% at weeks 4-24, indicating its potential effectiveness in vaping cessation programs with minimal serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline and counseling for vaping cessation: a double-blind, randomized, parallel-group, placebo-controlled trial. Caponnetto, P., Campagna, D., Ahluwalia, JS., et al.[2023]

In a study of 101 participants, 43% successfully quit smoking after 12 weeks of treatment with varenicline and interactive voice response (IVR) support, but extended IVR did not significantly improve long-term abstinence rates.

At the 2-year mark, only 13% of the original participants remained smoke-free, with no significant difference in relapse rates between those who received extended IVR support and those who did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended interactive voice response telephony (IVR) for relapse prevention after smoking cessation using varenicline and IVR: a pilot study. McNaughton, B., Frohlich, J., Graham, A., et al.[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]

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]

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