E-Cigarettes or Medication for Tobacco Use

(STEPS Trial)

Recruiting at 2 trial locations

Overseen By Elizabeth Chapman

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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate whether non-cigarette tobacco products, namely e-cigarettes (nicotine vapes), can help people who smoke and are in treatment for substance use disorder quit smoking by switching completely to e-cigarettes as compared to FDA-approved medications, namely nicotine replacement therapy in the form of patches and lozenges. Participation will last 6 months and will include five in-person study visits and eleven virtual assessments. Participants will also complete a short daily diary on their phones each day for the first twelve weeks. To qualify, participants must be within 30 days of SUD treatment program admission. This study is being conducted at three outpatient SUD treatment programs across South Carolina. These sites include: 1) the Center for Drug and Alcohol Problems (CDAP) in Charleston, SC, 2) Behavioral Health Services of Pickens County (BHSPC) in Pickens, SC, and 3) Shoreline Behavioral Health Services in Conway, SC. the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.

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.

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

Research shows that e-cigarettes can help people quit smoking by providing nicotine and a similar experience to smoking regular cigarettes. Studies found that e-cigarettes are as effective as other nicotine replacement therapies, and many smokers who tried e-cigarettes were able to quit or significantly reduce their smoking. ^{1 2 3 4 5}

What safety data exists for e-cigarettes and smoking cessation medications?

Research shows that both e-cigarettes and traditional smoking cessation medications have reported adverse events (unwanted side effects). E-cigarettes are generally considered to have fewer adverse events compared to traditional nicotine replacement therapies, but the safety of long-term use is still debated. ^{6 7 8 9 10}

How does the treatment of quitting smoking using e-cigarettes differ from other treatments?

This treatment is unique because it involves switching to e-cigarettes, which provide both nicotine and simulate the act of smoking, offering a behavioral and pharmacological substitute for traditional cigarettes. Unlike standard nicotine replacement therapies (NRT) or prescription medications, e-cigarettes can help smokers who have previously failed to quit with approved methods by providing an alternative route to reduce or stop smoking. ^{2 4 11 12 13}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Does utilization of electronic cigarettes facilitate smoking cessation compared to other interventions? [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Turkey pubmed.ncbi.nlm.nih.gov

Effectiveness of Behavioral and Pharmacological Smoking Cessation Treatment in Patients with Failed Attempt at Quitting with E-cigarettes. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Switching away from smoking at 12 months among adult JUUL users varying in recent history of quit attempts made with and without smoking cessation medication. [2023]

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

Efficacy of electronic cigarettes for smoking cessation. [2018]

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

Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study. [2018]

7. 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]

8. Australia pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of smoking cessation with varenicline plus counselling for e-cigarettes users (VAREVAPE): A protocol for a randomized controlled trial. [2021]

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

E-cigarettes: What's known, what's unknown. [2018]

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

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

12. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of Non-Nicotinic E-Cigarettes to Reduce Cue- and Abstinence-Induced Cigarette Craving in Non-Treatment Seeking Daily Dependent Smokers. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Correlates of use of electronic cigarettes versus nicotine replacement therapy for help with smoking cessation. [2021]