Quitting Strategies + Varenicline for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen by Lisa Fucito, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Yale University

Must be taking: Varenicline

Must not be taking: Smoking cessation drugs

Disqualifiers: Pregnancy, Severe renal impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products at the same time (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by e-cigarettes is more effective for quitting both products. The study will also compare the effect of treatment on health-related biomarkers. All participants will receive varenicline, a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e., links to text-based support, self-change booklet). Varenicline helps to reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.

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.

What data supports the effectiveness of this treatment for smoking cessation?

Research shows that combining varenicline (a medication to help quit smoking) with counseling can significantly improve quit rates. In one study, at least 44% of patients successfully quit smoking after 12 weeks of varenicline treatment, and other studies found that adding counseling to varenicline further increased the chances of quitting. ^{1 2 3 4 5}

Is varenicline safe for smoking cessation?

Varenicline, also known as Chantix, has been linked to some safety concerns, including possible neuropsychiatric side effects (mental health-related issues), seizures, and interactions with alcohol. There are also reports of adverse cardiovascular events (heart-related issues) associated with its use. It's important to discuss these risks with a healthcare provider before starting treatment. ^{6 7 8 9 10}

How is the drug varenicline unique for smoking cessation?

Varenicline is unique because it works by partially activating the same receptors in the brain that nicotine does, which helps reduce withdrawal symptoms and cravings while also making smoking less satisfying. This mechanism is different from other treatments like nicotine replacement therapy or bupropion, and it has been shown to be more effective in helping people quit smoking. ^{1 3 7 11 12}

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Counseling (Behavioral Intervention)
• Guided Self-Change Booklets (Behavioral Intervention)
• Varenicline (Anti-smoking Medication)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale University New Haven, CT

Who Is Running the Clinical Trial?

Yale University Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

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

Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. [2015] This study evaluated the effect of varenicline in combination with counseling to assist long-term nicotine replacement therapy (NRT) users to quit NRT.

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

Smoking quit rates among patients receiving pharmacotherapy who received general practitioner counselling versus intensive counselling: a retrospective cohort study. [2023] Behavioral treatments can augment the success of pharmacotherapy in smoking cessation. The aim of this study was to compare smoking quit rates between patients receiving individual counseling with their general practitioner during office visits or intensive counselling with behavioral support, both augmented by varenicline.

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

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015] Telephone counseling through quitlines combined with cessation medication is an effective strategy to support tobacco cessation. This study assessed the characteristics of quitline enrollees selecting varenicline (Chantix) compared with nicotine replacement therapy (NRT) medication and evaluated the cessation outcomes (7-day point prevalence) among these enrollees at 3 and 6 months after program completion.

4. England 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. [2015] Smoking cessation interventions in outpatient settings have been demonstrated to be cost effective. Given this evidence, we aimed to evaluate the effectiveness of varenicline tartrate plus Quitline-counselling compared with Quitline-counselling alone when initiated in the inpatient setting.

5. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness. [2015] Varenicline is a selective nicotinic receptor partial agonist used to aid in the process of smoking cessation. Research on varenicline's approval for marketing demonstrated that after 12 weeks of treatment, at least 44% of patients successfully quit smoking and, on average, 13% of individuals discontinued therapy due to an adverse drug event (ADE). Growing postmarketing data linked varenicline to an increase in neuropsychiatric symptoms.

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

Varenicline and counseling for vaping cessation: a double-blind, randomized, parallel-group, placebo-controlled trial. [2023] Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping.

7. United States pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). [2015] Varenicline is the generic name for Chantix, the newest drug available for the treatment of tobacco dependence. In a randomized controlled clinical trial, the abstinence rate at 1 year for patients using varencline was superior to that of patients in the group using bupropion SR (Zyban) and in the placebo group (11). Varenicline reduces nicotine withdrawal symptoms, cigarette craving and nicotine satisfaction. Post-market reports prompted a warning of serious adverse neuropsychiatric events in patients taking varenicline. As is the case with any surgical procedure and/or prescription medication, full disclosure of the risks and benefits should be discussed with the patient. The significant health benefits of quitting smoking should be weighed against the individual's risk of adverse events associated with the use of varenicline for smoking cessation.

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

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. [2018] Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions.

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

Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. [2022] There have been postmarketing reports of adverse cardiovascular events associated with the use of varenicline, a widely used smoking cessation drug. We conducted a systematic review and meta-analysis of randomized controlled trials to ascertain the serious adverse cardiovascular effects of varenicline compared with placebo among tobacco users.

10. England 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). [2018] Inpatient medical settings offer an opportunistic environment for initiating smoking cessation interventions to patients reflecting on their health. Current evidence has shown the superior efficacy of varenicline tartrate (VT) for smoking cessation compared with other tobacco cessation therapies; however, recent evidence also has highlighted concerns about the safety and tolerability of VT. Given these apprehensions, we aimed to evaluate the safety and effectiveness of VT plus quitline-counseling compared to quitline-counseling alone in the inpatient medical setting.

11. United States 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. [2023] Varenicline, a partial agonist at the alpha4beta2 nicotinic acetylcholine receptor, has the potential to aid smoking cessation by relieving nicotine withdrawal symptoms and reducing the rewarding properties of nicotine.

12. England pubmed.ncbi.nlm.nih.gov

Extended interactive voice response telephony (IVR) for relapse prevention after smoking cessation using varenicline and IVR: a pilot study. [2021] There is a significant resumption of smoking following smoking cessation using varenicline. Both smoking cessation medications and counseling have been shown to increase smoking quit rates at one year. Thus, the combination of varenicline and interactive voice response (IVR) telephony followed by extended IVR may further improve smoking cessation rates at one and two years.