E-Cigarettes or Medication for Smoking Cessation

Overseen By Tracy Smith, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Pregnant, Breastfeeding, Moving, others

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

Compensation: Varies

Number of Visits: 8

Duration: 11 weeks

225 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that varenicline (Chantix) is effective for helping people quit smoking, with better results than some other medications. Electronic cigarettes (e-cigs) have also been used by many to quit smoking, but their effectiveness is not consistent across all studies. ^{1 2 3 4 5}

Is varenicline (Chantix) safe for smoking cessation?

Varenicline (Chantix) has been associated with some safety concerns, including neuropsychiatric side effects (mental health-related issues), seizures, and interactions with alcohol. There have also been reports of serious adverse events like withdrawal-emergent dyskinesias (involuntary movements) and other psychiatric effects. ^{1 2 6 7 8}

How do e-cigarettes and medication differ from other smoking cessation treatments?

E-cigarettes offer a unique approach by providing both nicotine and a behavioral substitute for smoking, while medications like varenicline (Chantix) and nicotine replacement therapy (NRT) focus on reducing nicotine cravings through different mechanisms. E-cigarettes mimic the act of smoking, which can help with the habitual aspect of smoking cessation, whereas medications work by altering brain chemistry to reduce cravings. ^{4 9 10 11 12}

What is the purpose of this trial?

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Research Team

Tracy Smith

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for adults over 21 who have tried to quit smoking before using FDA-approved methods and are interested in reducing harm from tobacco or quitting. It's not for those pregnant, breastfeeding, planning pregnancy, living with someone in the study, or moving away soon.

Inclusion Criteria

Interest in reducing harms from tobacco use or quitting smoking

I am over 21 and have tried to quit smoking with FDA-approved medication before.

Exclusion Criteria

Household member currently enrolled in the study

Pregnant, breastfeeding, or trying to become pregnant

Planning to move out of the area within the next 7 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the E-Cigarette Group or the Meds Group and receive study products for 11 weeks

11 weeks

Weekly phone calls for the initial 7 weeks, plus an 11-week phone call

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person) at 6 months

Treatment Details

Interventions

• E-Cigarette
• Medication

Trial Overview The study compares two ways to quit smoking: one group tries e-cigarettes with a choice of brand and flavor; the other uses medications like nicotine patches/lozenges or Chantix. Participants will be randomly assigned to a group and followed up for 6 months.

Participant Groups

Group I: Choice of Medication Experimental Treatment 1 Intervention

This arm includes participants randomly assigned to the Meds Group. Participants will choose between 1) combo NRT and 2) varenicline. The NRT will consist of transdermal NRT and nicotine lozenge. Participants will receive study product for 11 weeks.

Group II: Choice of E-Cigarette Experimental Treatment 1 Intervention

This arm includes participants randomly assigned to the E-Cigarette Group. Participants will choose between two different brands of e-cigarettes and choose up to two different flavors. Participants will receive study product for 11 weeks.

E-Cigarette is already approved in United States, European Union, Canada for the following indications:

Approved in United States as E-Cigarette for:

• Smoking cessation aid

Approved in European Union as E-Cigarette for:

• Smoking cessation aid

Approved in Canada as E-Cigarette for:

• Smoking cessation aid

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A comprehensive analysis of 8,867,135 reports from the FDA Adverse Event Reporting System revealed that nicotine replacement therapies (NRTs) are associated with several adverse events, including nausea, dizziness, and application site reactions, indicating the need for careful monitoring of their use.

Electronic cigarettes also reported adverse events such as dizziness and increased heart rate, suggesting that while they may be used for smoking cessation, they are not without risks and should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004-2016. Motooka, Y., Matsui, T., Slaton, RM., et al.[2022]

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 has been shown to be more effective than a placebo for smoking cessation in multiple randomized clinical trials, indicating its strong efficacy as a smoking cessation aid.

While electronic cigarettes (ECs) also showed some effectiveness in helping smokers quit, they were not consistently effective across all studies, suggesting that varenicline may be a more reliable option for those looking to stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Looking Back and Going Forward: Roles of Varenicline and Electronic Cigarettes in Smoking Cessation. Oloyede, EO., Ola, O., Kolade, VO., et al.[2021]

Combination treatments, particularly varenicline with nicotine patches, can lead to higher smoking abstinence rates compared to using varenicline alone, especially in heavy smokers who are more dependent on tobacco.

Overall, combined medications were well tolerated, making them a viable option for hard-core smokers who have struggled to quit with standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combinations of pharmacological treatments in smoking cessation. A systematic review]. Underner, M., Perriot, J., Peiffer, G., et al.[2021]

In a study of over 200,000 adults, varenicline (VAR) was found to have lower smoking-attributable and all-cause medical costs compared to nicotine-replacement therapy patches (NRT-P) over a year, suggesting it may be a more cost-effective smoking cessation option.

Among patients who adhered to their treatment, VAR still showed lower annual medical costs despite higher pharmacy costs, indicating that the overall financial burden of smoking cessation may be reduced with VAR compared to NRT-P.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare Costs of Smokers Using Varenicline Versus Nicotine-Replacement Therapy Patch in the United States: Evidence from Real-World Practice. Lee, LJ., Li, Q., Bruno, M., et al.[2020]

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]

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]

Varenicline, a medication used to help people quit smoking, is known to have some psychiatric and behavioral side effects, including reports of tardive dyskinesia, although these were not previously documented in literature.

This study presents the first two documented cases of withdrawal emergent dyskinesias associated with varenicline, highlighting a potential safety concern for users of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Withdrawal-Emergent Dyskinesias following Varenicline Therapy. Toffey, BA., Rabin, M., Kurlan, R.[2020]

Nicotine e-cigarettes were found to be more effective for smoking cessation compared to licensed nicotine replacement therapies (NRT), with participants using e-cigarettes being 49% more likely to remain abstinent from smoking than those using NRT.

The review included 7 e-cigarette trials with a total of 5,674 participants and 9 NRT trials with 6,080 participants, but many e-cigarette studies had a moderate to high risk of bias, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. Chan, GCK., Stjepanović, D., Lim, C., et al.[2023]

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]

In a study involving 1251 adult smokers, combining varenicline with a nicotine patch or extending varenicline treatment from 12 to 24 weeks did not significantly improve smoking cessation rates after 52 weeks.

The primary outcome of 7-day point prevalence abstinence was similar across all treatment groups, indicating that neither combination therapy nor longer treatment duration provided additional benefits for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. Baker, TB., Piper, ME., Smith, SS., et al.[2022]

In a study of 886 adults, e-cigarettes were found to be significantly more effective for smoking cessation than nicotine-replacement products, with a 1-year abstinence rate of 18.0% compared to 9.9% for nicotine-replacement therapy.

Participants using e-cigarettes reported greater declines in cough and phlegm production over the year, although they experienced more throat or mouth irritation compared to those using nicotine-replacement products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. Hajek, P., Phillips-Waller, A., Przulj, D., et al.[2022]

References

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

Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004-2016. [2022]

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

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

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

Looking Back and Going Forward: Roles of Varenicline and Electronic Cigarettes in Smoking Cessation. [2021]

4. France pubmed.ncbi.nlm.nih.gov

[Combinations of pharmacological treatments in smoking cessation. A systematic review]. [2021]

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

Healthcare Costs of Smokers Using Varenicline Versus Nicotine-Replacement Therapy Patch in the United States: Evidence from Real-World Practice. [2020]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Varenicline and counseling for vaping cessation: a double-blind, randomized, parallel-group, placebo-controlled trial. [2023]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Withdrawal-Emergent Dyskinesias following Varenicline Therapy. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]

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

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. [2022]

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

A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. [2022]