Varenicline + Counseling for Smoking Addiction

(Vape CAT 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.

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 data supports the effectiveness of the drug varenicline for smoking addiction?

Research shows that varenicline, also known as Chantix or Champix, is effective in helping people quit smoking. In clinical trials, people using varenicline had higher quit rates compared to those using a placebo or another drug called bupropion. Varenicline helps reduce withdrawal symptoms and cravings, making it easier for people to stop smoking. ^{1 2 3 4 5}

Is varenicline safe for humans?

Varenicline, used to help people stop smoking, has been linked to serious side effects like depression, suicidal thoughts, and heart problems. It's important to discuss these risks with a doctor before starting the treatment. ^{1 6 7 8 9}

How does the drug varenicline differ from other smoking cessation treatments?

Varenicline is unique because it is a partial agonist of the alpha4beta2 nicotinic acetylcholine receptor, which helps reduce cravings and withdrawal symptoms while blocking nicotine's rewarding effects. It has shown higher abstinence rates compared to other treatments like bupropion and placebo, although it may have psychiatric side effects that require monitoring. ^{1 2 4 5 10}

Research Team

Erin A McClure, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

Treatment of nicotine dependence with Chantix (varenicline). [2015]

2. Belgium pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Varenicline: a review of its use as an aid to smoking cessation therapy. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Varenicline in smoking cessation. [2017]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

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

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

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

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. [2018]

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

Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. [2022]

10. New Zealand 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. [2021]