Varenicline + Counseling for Smoking Addiction

(VapeCAT Trial)

Recruiting at 2 trial locations

Overseen By Elizabeth Chapman, MA, LPC, LAC, AADC

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Medical University of South Carolina

Must be taking: Varenicline

Must not be taking: Smoking cessation medications

Disqualifiers: Serious psychiatric disorders, cigarettes, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the stop-smoking medication varenicline helps people quit e-cigarettes, particularly those who also use cannabis. The study will examine the interaction between tobacco and cannabis during the quitting process. Participants will receive varenicline treatment for 12 weeks along with financial incentives. Individuals who use e-cigarettes daily or almost daily and regularly use cannabis, and wish to quit e-cigarettes, may be suitable for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment, providing insights into its benefits for a broader range of patients.

Will I have to stop taking my current medications?

The trial requires that you do not use any medications that help with smoking cessation or that would interfere with varenicline. If you are on such medications, you may need to stop them to participate.

What is the safety track record for varenicline and counseling?

Research has shown that varenicline, an FDA-approved medication to help people quit smoking, is generally safe. Previous studies indicate that many individuals trying to quit smoking have tolerated varenicline well. Common side effects include nausea, trouble sleeping, and vivid dreams, which are usually mild.

Many smokers have used varenicline as part of a program to quit smoking that includes counseling and support. Although it is not yet approved for quitting e-cigarettes, its safety record for quitting cigarettes provides some insight into its potential effectiveness in this trial. It is important to consult a healthcare provider if there are any concerns or side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatment using varenicline for smoking addiction because it works by targeting specific receptors in the brain that reduce cravings and withdrawal symptoms, which is different from traditional nicotine replacement therapies. While most smoking cessation treatments focus on replacing nicotine, varenicline operates by blocking the pleasant effects of nicotine, making it easier for users to quit. Additionally, when combined with counseling, varenicline may enhance the overall success rates of quitting smoking, providing a more comprehensive approach than medication alone.

What is the effectiveness track record for varenicline in smoking cessation?

Studies have shown that varenicline, which participants in this trial may receive, helps people quit smoking. Research indicates that varenicline is almost three times more effective than nicotine patches for some individuals. Evidence from multiple trials shows that varenicline outperforms a placebo, even a year after treatment. While it's approved for quitting cigarettes, data for quitting e-cigarettes specifically is not yet available. However, given its success with cigarettes, varenicline is expected to assist those trying to quit e-cigarettes as well. ^{2 6 7 8 9}

Who Is on the Research Team?

Erin A McClure, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 who use both e-cigarettes and cannabis. They don't need to want to quit using cannabis but should be interested in stopping e-cigarette use. The study takes place at three locations in South Carolina.

Inclusion Criteria

Use e-cigarettes daily or near daily in the past month

Must submit a positive instant-read urine cotinine test at screening (≥ 200 ng/ml)

Self-reported use of cannabis on at least 10 out of the past 30 days or must submit a positive qualitative urinary cannabinoid test at screening (> 50 ng/ml)

Exclusion Criteria

Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) in the past three months that may interfere with study performance

Use of cigarettes on 10+ days in the past 30

Currently pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive e-cigarette cessation treatment using varenicline and financial incentives

12 weeks

Regular visits for monitoring and support

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingency management
• Counseling
• Varenicline

Trial Overview The study tests the effectiveness of varenicline, a pill approved for cigarette cessation, combined with financial rewards and counseling, to help people stop using e-cigarettes. Participants will receive this treatment over a period of 12 weeks.

How Is the Trial Designed?

Group I: Co-use group Experimental Treatment 3 Interventions

E-cigarette and cannabis co-use group

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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Varenicline (Champix) is a newly approved medication for smoking cessation that acts as a partial agonist of nicotinic receptors, offering a different mechanism of action compared to traditional therapies like nicotine replacement and bupropion.

Recent studies indicate that varenicline is effective in helping individuals quit smoking and may have advantages over existing treatments, although potential side effects are also discussed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug of the month. Varenicline (Champix)]. Vandemergel, X.[2015]

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]

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]

Varenicline, an FDA-approved medication for smoking cessation, significantly increases the chances of quitting smoking, with continuous abstinence rates 2.7 to 3.1 times higher than placebo over a 52-week period after 12 weeks of treatment.

In addition to helping smokers quit, varenicline reduces cravings and withdrawal symptoms, making it a valuable option for those looking to stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline: a review of its use as an aid to smoking cessation therapy. Keating, GM., Siddiqui, MA.[2018]

In a study of 2,682 patients using varenicline for smoking cessation, nausea and vomiting were the most common reasons for discontinuation and the most frequently reported adverse drug reactions, highlighting the need for patient monitoring regarding gastrointestinal side effects.

While some psychiatric events were reported, including anxiety and depression, all cases of suicidal behavior involved patients with prior psychiatric conditions, suggesting that clinicians should closely monitor individuals with such histories when prescribing varenicline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Kasliwal, R., Wilton, LV., Shakir, SA.[2021]

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]

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]

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 of 70 patients with brain lesions, those who quit smoking after their injury (Quitters) did not show higher rates of depression compared to those who continued smoking (Non-Quitters), indicating that smoking cessation itself is not linked to increased depression in this population.

The findings suggest that the neuropsychiatric side effects associated with varenicline, such as depression, are likely due to the medication rather than the act of quitting smoking, as both groups exhibited similar levels of depression and related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation after brain damage does not lead to increased depression: implications for understanding the psychiatric complications of varenicline. Tranel, D., McNutt, A., Bechara, A.[2021]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534846/

Varenicline - StatPearls - NCBI Bookshelf - NIH [14] A recent study showed that varenicline was almost 3 times more effective than nicotine patches in helping pregnant women quit smoking. [15] Data on ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820435

Varenicline and Nicotine Replacement Therapy for ... If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871622004094

Varenicline and related interventions on smoking cessation (2006 ) pooled four trials and found that varenicline was superior to placebo treatment even one year later, and they also showed that ...

4. tobaccopreventioncessation.com tobaccopreventioncessation.com/Use-of-low-dose-varenicline-in-patients-who-do-not-tolerate-standard-dose-varenicline,194629,0,2.html

Use of low-dose varenicline in patients who do not tolerate ... Currently, available research shows that low-dose varenicline is likely similarly, or minimally less effective compared to standard-dose ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01387425

Efficacy And Safety Of Smoking Cessation With Varenicline ... Recently, randomized, controlled clinical trials have shown that varenicline at a dose of 1 mg twice a day is superior to placebo for smoking cessation (19-21).

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf

CHANTIX® (varenicline) - accessdata.fda.gov • Other smoking cessation therapies: Safety and efficacy in combination with other smoking cessation therapies has not been established. Coadministration of ...

7. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-varenicline.html

How to Use Varenicline | Quit Smoking Varenicline is a pill you take twice a day. You start taking it at least one week before you quit, gradually increasing the dose.

8. mayoclinic.org mayoclinic.org/drugs-supplements/varenicline-oral-route/description/drg-20068324

Varenicline (oral route) - Side effects & dosage Varenicline is used together with a support program to help you stop smoking. The program will include counseling and educational materials.

9. labeling.pfizer.com labeling.pfizer.com/showlabeling.aspx?id=557

Highlights of Prescribing Information Patients should begin CHANTIX dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and ...