Dual Use Cessation for Smoking
Recruiting in Palo Alto (17 mi)
Overseen byMegan E Piper, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Wisconsin, Madison
Must be taking: Varenicline, Nicotine patches
Must not be taking: Bupropion
Disqualifiers: Psychosis, Bipolar, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The overarching goal of this research is to determine the most effective approach for helping dual users of cigarettes and electronic nicotine delivery systems (ENDS) quit smoking. 500 participants will be enrolled and can expect to be on study for 12 months.
Will I have to stop taking my current medications?
If you are using nicotine replacement, varenicline, or bupropion (only for smoking cessation), you will need to stop taking them to join the trial. If you are taking bupropion for other reasons, like depression, you cannot participate in the trial.
What data supports the effectiveness of the drug varenicline for smoking cessation?
Research shows that varenicline, also known as Chantix, is effective in helping people quit smoking by reducing withdrawal symptoms and cravings. It has been found to be more effective than bupropion (another smoking cessation drug) and placebo in several studies, with improved quit rates and reduced chances of relapse.
12345Is varenicline safe for humans?
Varenicline, used to help people stop smoking, has been linked to some psychiatric side effects like depression and suicidal thoughts. While it can be effective, it's important to discuss these potential risks with a healthcare provider before starting the treatment.
16789What makes the drug varenicline unique for smoking cessation?
Varenicline is unique because it is a partial agonist (a type of drug that activates receptors but not as strongly as a full agonist) at the nicotinic acetylcholine receptor, which helps reduce nicotine withdrawal symptoms and cravings, making it more effective than other treatments like bupropion and nicotine replacement therapy.
134910Eligibility Criteria
This trial is for individuals who use both cigarettes and electronic nicotine delivery systems (ENDS) and are looking to quit. Participants will be involved in the study for 12 months.Inclusion Criteria
Able to read and communicate in English
Smoking ≥ 5 cigarettes per day for the past 6 months
Vaping weekly for at least 6 months
+4 more
Exclusion Criteria
I am not currently pregnant or breastfeeding.
I am currently taking bupropion for reasons other than to quit smoking.
Plans to move out of the area for the next 12 months
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either varenicline or nicotine patches for 12 weeks, along with counseling sessions
12 weeks
1-4 counseling sessions
Follow-up
Participants are monitored for smoking and vaping cessation outcomes
52 weeks
Regular follow-up assessments
Participant Groups
The study aims to find the best way to help dual users of cigarettes and ENDS quit smoking by comparing different cessation methods: Dual Focused Cessation Counseling, Varenicline with a single session, Nicotine patch, or Smoking Focused Cessation Counseling with four sessions.
8Treatment groups
Active Control
Group I: Varenicline, Smoking Focused, 4 sessionsActive Control3 Interventions
Group II: Varenicline, Dual Focused, 1 sessionActive Control3 Interventions
Group III: Nicotine Patches, Smoking Focused, 4 sessionsActive Control3 Interventions
Group IV: Varenicline, Smoking Focused, 1 sessionActive Control3 Interventions
Group V: Varenicline, Dual Focused, 4 sessionsActive Control3 Interventions
Group VI: Nicotine Patches, Smoking Focused, 1 sessionActive Control3 Interventions
Group VII: Nicotine Patches, Dual Focused, 1 sessionActive Control3 Interventions
Group VIII: Nicotine Patches, Dual Focused, 4 sessionsActive Control3 Interventions
Varenicline is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Chantix for:
- Smoking cessation
- Dry eye disease
🇪🇺 Approved in European Union as Champix for:
- Smoking cessation
🇨🇦 Approved in Canada as Champix for:
- Smoking cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Wisconsin-Madison School of Medicine and Public HealthMadison, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
National Cancer Institute (NCI)Collaborator
References
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.
Effects of varenicline on abstinence and smoking reward following a programmed lapse. [2021]Varenicline (Chantix®) is an efficacious first-line medication for smoking cessation. Studies suggest that one mechanism by which varenicline facilitates sustained smoking abstinence is by reducing the likelihood of relapse to smoking when a lapse, or slip, occurs during a quit attempt. The present study extends this line of research by conducting a prospective laboratory study to examine the relapse prevention effects of varenicline following a programmed lapse.
[Drug of the month. Varenicline (Champix)]. [2015]Smoking is responsible for 20,000 premature deaths per year in Belgium. Paradoxically, few drugs are efficient to induce tobacco cessation and to decrease relapse. Until a few weeks ago nicotin replacement therapy and bupropion only were validated in this indication. Varenicline (Champix), a partial agonist of nicotinic receptors, is a novel type of drugs currently also accepted for sale for smoking cessation. This article dwells on recent publications about efficacy of varenicline. Position, side-effects and advantages of the drug are discussed.
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.
Varenicline: a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist approved for smoking cessation. [2017]Tobacco smoking remains a significant health problem in the United States. It has been associated with staggering morbidity and mortality, specifically due to malignancies and cardiovascular disease. Smoking cessation can be difficult and frequently requires pharmacologic interventions in addition to nonpharmacologic measures. Previously available agents are nicotine replacement products and bupropion, which increased quit rates by about 2-fold compared with placebo. Varenicline is the first drug in a new class known as the selective alpha4beta2 nicotinic receptor partial agonists. In several randomized, double-blind, 52-week clinical trials involving healthy chronic smokers, varenicline demonstrated superiority to placebo and bupropion in terms of efficacy measures. Additionally, it improved tobacco withdrawal symptoms and reinforcing effects of smoking in relapsed patients. Patients should start therapy in combination with tobacco cessation counseling 1 week before quit date and continue the regimen for 12 weeks. The dose of varenicline should be titrated to minimize nausea. The recommended dosage is 0.5 mg once daily (QD) on days 1-3; titrate to 0.5 mg twice daily (BID) on days 4-7; and 1 mg BID starting on day 8. An additional 12-week maintenance therapy may be considered for those who achieve abstinence. The most common side effects are nausea (30%), insomnia (18%), headache (15%), abnormal dreams (13%), constipation (8%), and abdominal pain (7%). Overall, varenicline is a breakthrough in the management of tobacco addiction and has demonstrated good efficacy in motivated quitters. It also provides an option for smokers who cannot tolerate other pharmacologic interventions.
Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. [2022]Varenicline (Chantix), Champix) has shown efficacy and tolerability as an aid to smoking cessation. In postmarketing surveillance, neuropsychiatric symptoms have appeared; however, their incidence and causal relationship to varenicline is not known.
Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. [2021]Varenicline tartrate (Champix), a new smoking cessation medicine, was launched in the UK in December 2006. Varenicline is a highly selective partial agonist of the alpha(4)beta(2) nicotinic acetylcholine receptor (alpha(4)beta(2) receptor). The partial agonistic binding leads to alleviation of symptoms of craving and withdrawal, and simultaneously prevents nicotine from binding to the alpha(4)beta(2) receptor thereby causing reduction in the rewarding and reinforcing effects of smoking. Regulatory concerns have arisen about psychiatric events associated with varenicline, including depression, suicidal ideation and changes in behaviour/emotion.
Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]Varenicline (Champix(®)), launched in the UK in December 2006, is indicated for the treatment of smoking cessation in adults (≥18 years of age). In 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK issued a warning suggesting that varenicline was associated with disparate neuropsychiatric symptoms, including depression, suicidal thoughts and behaviour. In response to this regulatory warning, the Drug Safety Research Unit conducted a modified prescription-event monitoring (M-PEM) study to monitor the safety of varenicline.
Withdrawal-Emergent Dyskinesias following Varenicline Therapy. [2020]Varenicline (Chantix[R]) is a nicotinic acetylcholine receptor partial agonist used to aid smoking cessation. Adverse psychiatric and behavioral effects of the drug are recognized and national drug monitoring has included reports of tardive dyskinesia, but no cases have been described in the literature. We now report the first two cases of varenicline-related withdrawal emergent dyskinesias.
Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]Strategies for assisting smoking cessation include behavioural counselling to enhance motivation and to support attempts to quit and pharmacological intervention to reduce nicotine reinforcement and withdrawal from nicotine. Three drugs are currently used as first line pharmacotherapy for smoking cessation, nicotine replacement therapy, bupropion and varenicline. Compared with placebo, the drug effect varies from 2.27 (95% CI 2.02, 2.55) for varenicline, 1.69 (95% CI 1.53, 1.85) for bupropion and 1.60 (95% CI 1.53, 1.68) for any form of nicotine replacement therapy. Despite some controversy regarding the safety of bupropion and varenicline, regulatory agencies consider these drugs as having a favourable benefit/risk profile. However, given the high rate of psychiatric comorbidity in dependent smokers, practitioners should closely monitor patients for neuropsychiatric symptoms. Second-line pharmacotherapies include nortriptyline and clonidine. This review also offers an overview of pipeline developments and issues related to smoking cessation in special populations such as persons with psychiatric comorbidity and pregnant and adolescent smokers.