E-Cigarettes or Medication for Tobacco Use

(STEPS Trial)

Recruiting at 2 trial locations

Overseen By Ela Williams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Smoking cessation drugs

Disqualifiers: Unstable medical, psychiatric, pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether switching to e-cigarettes or using nicotine patches and lozenges can help people quit smoking, particularly those undergoing treatment for substance use disorder. Participants will use either e-cigarettes or a combination of nicotine patches and lozenges for 12 weeks. The trial is open to individuals who smoke at least five cigarettes daily and have recently begun outpatient treatment for substance use disorder. Participants should have attempted to quit smoking before and be interested in reducing or quitting smoking. The study will occur in three locations across South Carolina. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance smoking cessation strategies for individuals with substance use disorders.

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 be using any current medication for smoking cessation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that e-cigarettes are generally perceived as safer than regular cigarettes and are about as safe as other approved methods for quitting smoking, such as nicotine patches or lozenges. However, e-cigarettes carry risks. They often contain nicotine, which is addictive and can harm health. The long-term effects of using e-cigarettes remain unclear.

Nicotine replacement therapy (NRT), including patches and lozenges, is well-researched and widely used to aid smoking cessation. Studies have found that NRT can nearly double the chances of quitting. While NRT can cause some side effects, they are usually not serious or life-threatening.

Both e-cigarettes and NRT in this trial are considered relatively safe, but each has its own risks. Choosing between them might depend on individual preference and specific health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for quitting tobacco use because they offer new approaches that might be more effective for some people. Unlike traditional methods like nicotine patches or gum, switching to e-cigarettes provides a familiar smoking experience without the harmful tobacco smoke. This might help ease the transition for smokers. On the other hand, the medication approach uses a combination of nicotine patches and lozenges to provide a steady release of nicotine, potentially reducing withdrawal symptoms. Both methods aim to support smokers in quitting by addressing different aspects of their addiction.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Research on using e-cigarettes to quit smoking has shown mixed results. Some studies suggest that e-cigarettes can aid quitting more effectively than counseling alone, while others find they don't consistently improve quitting rates. In this trial, participants in one arm will switch to an e-cigarette for 12 weeks. Conversely, nicotine replacement products like patches and lozenges are known to help with withdrawal and cravings. Participants in another arm of this trial will receive combination nicotine replacement therapy (NRT) with transdermal patches and nicotine lozenges for 12 weeks. A review of several studies found that using nicotine therapy with some support can lead to about a 15.2% quit rate over six months. Both methods can be effective, but success depends on the individual and the support received. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The STEPS trial is for individuals who smoke and are currently in treatment for substance use disorder. Participants must have joined a SUD program within the last 30 days and be willing to try quitting smoking by either switching to e-cigarettes or using FDA-approved nicotine replacement therapies, along with counseling.

Inclusion Criteria

Smoke at least 5 cigarettes per day regularly for the past 6 months

Be within 30 days of SUD treatment program admission

Must submit a breath CO sample of ≥ 7 parts per million at screening and a positive instant-read urinary cotinine test (metabolite of nicotine, cut off of 200 ng/ml)

Exclusion Criteria

Pregnant, breastfeeding, or trying to become pregnant

Currently using an ENDS on 20+ days out of the past 30.

I do not have any major health or mental issues affecting my safety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomized to either switch to e-cigarettes or use nicotine replacement therapy for 12 weeks

12 weeks

5 visits (in-person), 11 visits (virtual)

Follow-up

Participants are monitored for smoking abstinence and treatment outcomes after the end of the treatment phase

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• Quitting using Medication
• Switching to E-Cigarette

Trial Overview

This study compares the effectiveness of e-cigarettes versus nicotine patches and lozenges in helping people quit smoking during their substance use disorder treatment. It includes five in-person visits and eleven virtual check-ins over six months, plus daily diary entries via phone for twelve weeks.

How Is the Trial Designed?

Group I: Switching to an E-Cigarette Experimental Treatment 2 Interventions

This arm includes participants randomly assigned to the E-Cigarette Group. Participants will receive a study-provided e-cigarette product for 12 weeks.

Group II: Medication Experimental Treatment 2 Interventions

This arm includes participants randomly assigned to the medication group. Participants will receive combination nicotine replacement therapy (NRT). The NRT will consist of transdermal patches and nicotine lozenges. Participants will receive study product for 12 weeks.

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+

Published Research Related to This Trial

In a study of 109 patients who struggled to quit smoking using e-cigarettes, only 5.5% managed to quit temporarily, highlighting the challenges of e-cigarette dependence.

However, after receiving pharmacological treatment and behavioral/cognitive training, 43.1% of participants successfully quit smoking, indicating that these interventions can significantly improve cessation rates for those who did not succeed with e-cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Behavioral and Pharmacological Smoking Cessation Treatment in Patients with Failed Attempt at Quitting with E-cigarettes. Duru Çetinkaya, P., Turan, A., Deniz, PP.[2021]

In a study of 959 participants, e-cigarette users (e-smokers) had a significantly higher rate of sustained tobacco smoking abstinence at 12 months (61.9%) compared to tobacco smokers (20.6%) and dual smokers (22.0%), indicating that e-cigarettes may be an effective tool for smoking cessation.

Using e-cigarettes alongside tobacco smoking did not improve the chances of quitting or reduce the number of tobacco cigarettes smoked, suggesting that e-cigarettes are more beneficial when used alone for those trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study. Manzoli, L., Flacco, ME., Fiore, M., et al.[2018]

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]

E-cigarettes have been shown to significantly reduce the desire to smoke and the number of cigarettes smoked per day in small clinical studies, suggesting they may help modify smoking habits.

While e-cigarettes may have fewer adverse effects compared to nicotine patches and can aid in short-term smoking reduction, there is limited evidence for their long-term effectiveness in achieving sustained smoking cessation beyond 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of electronic cigarettes for smoking cessation. Orr, KK., Asal, NJ.[2018]

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]

A meta-analysis of 18 studies involving 3756 papers found no significant difference in the rates of adverse events (AEs) like cough, oral irritation, and nausea between nicotine electronic cigarettes (ECs) and nicotine replacement therapies (NRTs).

The similar incidence of AEs suggests that the preference for nicotine ECs over NRTs is not driven by differences in adverse effects, indicating a need for further research to explore other factors influencing user choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. Anandan, AS., Leung, J., Chan, GCK., et al.[2023]

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]

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