E-Cigarettes and NRT for Tobacco Smoking

Recruiting at 1 trial location

Overseen By Justin McClendon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Breastfeeding, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot randomized controlled trial study aims to address the unmet need for feasible and efficacious strategies for reducing combustible cigarette (CC) use among people living with HIV/AIDS (PLWHA) in South Africa, which has the potential to significantly improve the health and long-term survival of PLWHA CC smokers. Using the proposed intervention, based on the Information-Motivation-Behavioral Skills (IMB), and a simultaneous embedded mixed methods approach, the investigators will evaluate a telehealth program targeting CC harm reduction, comparing E-cigarettes (EC) to nicotine replacement therapy (NRT) that is enhanced by integrating ecological momentary intervention (EMI) texting. As such, this proposal will significantly build research capacity in South Africa to conduct telehealth tobacco treatment interventions using innovative EMI approaches enhancing participants' engagement, as well as state-of-the art evaluation approaches.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing cigarette smoking among people living with HIV/AIDS.

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

Research shows that both e-cigarettes and nicotine replacement therapy (NRT) can help people quit smoking. Studies suggest that e-cigarettes might be as effective as NRT, like nicotine patches or gum, in helping people stop smoking. ^{1 2 3 4 5}

Are e-cigarettes and nicotine replacement therapies safe for humans?

E-cigarettes and nicotine replacement therapies (like nicotine gum, patches, and lozenges) have been studied for safety. Some reports indicate that e-cigarettes can cause nicotine poisoning, especially in children, and may have other health risks. However, they are generally considered safer than traditional smoking, and nicotine replacement therapies are widely used and considered safe for helping people quit smoking. ^{6 7 8 9 10}

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

E-cigarettes are unique because they mimic the act of smoking by delivering nicotine through vapor rather than smoke, which may help smokers who find it difficult to quit using traditional methods like nicotine replacement therapy (NRT). Unlike NRT, which typically comes in forms like patches or gum, e-cigarettes provide a similar hand-to-mouth action and sensory experience to smoking, potentially making them more appealing to some users. ^{1 3 7 11 12}

Research Team

Omar El-Shahawy

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adult people living with HIV/AIDS in South Africa who smoke cigarettes daily, speak Afrikaans, Xhosa, or English, own a mobile phone and are interested in reducing smoking but not necessarily quitting. Pregnant or breastfeeding individuals, those unable to consent, using other tobacco products recently, actively trying to quit smoking or with certain mental health conditions are excluded.

Inclusion Criteria

Reports daily CC smoking (≥ 5 CPD)

Adult PLWHA CC smokers

I speak Afrikaans, Xhosa, or English.

Exclusion Criteria

I do not have a current major depression or manic episode, and I haven't attempted suicide or had suicidal thoughts with a plan or intent in the past year.

Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)

I am unable to give my consent for participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either E-cigarettes or Nicotine Replacement Therapy (NRT) with phone counseling and ecological momentary intervention (EMI) texting

6 months

Regular virtual check-ins via telehealth

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 3 and 6 months

Treatment Details

Interventions

• Counseling
• E-Cigarette (EC)
• Nicotine Replacement Therapy (NRT)

Trial Overview The study tests a telehealth program aimed at reducing harm from cigarette smoking among PLWHA by comparing the use of E-cigarettes (EC) versus Nicotine Replacement Therapy (NRT), both supported by counseling and enhanced through motivational texting interventions.

Participant Groups

Group I: Nicotine Replacement Therapy (NRT) Experimental Treatment 2 Interventions

In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges).

Group II: Electronic Cigarette (EC) Experimental Treatment 2 Interventions

In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.

Group III: Control (Quit-Line Referral) Active Control 1 Intervention

Participants will receive referral to the existing South African Quitline. Participants will receive information to contact the Quitline if participants so choose, in addition to ecological momentary assessment (EMA) texting orientation.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

JOHN E FOGARTY INTERNATIONAL CENTER FOR ADVANCED STUDY IN THE HEALTH SCIENCES (FIC)

Collaborator

Trials

1

Recruited

90+

Findings from Research

In a randomized controlled trial with 135 smokers who struggled to quit using traditional methods, e-cigarettes (EC) led to a significantly higher rate of smoking reduction (26.5%) compared to nicotine replacement therapy (NRT) (6.0%), indicating greater efficacy for e-cigarettes in this population.

E-cigarettes also resulted in higher sustained abstinence rates at 6 months (19.1%) compared to NRT (3.0%), suggesting that e-cigarettes may be a more effective long-term solution for smokers seeking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: randomized controlled trial. Myers Smith, K., Phillips-Waller, A., Pesola, F., et al.[2022]

E-cigarettes were found to be more effective than nicotine-replacement therapy (NRT) for achieving continuous smoking abstinence for 6 months or longer, with a relative risk of 1.67 based on a meta-analysis of 5 randomized controlled trials involving 1748 participants.

There were no significant differences in adverse events between e-cigarettes and NRT, except for increased throat irritation associated with e-cigarettes, indicating a similar safety profile overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. Li, J., Hui, X., Fu, J., et al.[2022]

Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.

Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., et al.[2019]

Participants in the study generally had positive experiences using nicotine-containing e-cigarettes for smoking cessation, finding them helpful in managing nicotine cravings, especially when compared to nicotine replacement therapy (NRT).

Despite the positive feedback, there were concerns about the potential for developing a vaping habit as a replacement for smoking addiction, highlighting the need for further research on the long-term use of e-cigarettes as a quit aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant Experiences of a Quit Smoking Attempt Through Either Nicotine Replacement Therapy (NRT) Methods or the Use of an E-cigarette. Jones, G., McIntosh, E., Brose, LS., et al.[2022]

A study analyzing calls to U.S. poison centers from September 2010 to February 2014 revealed increasing reports of adverse health effects associated with e-cigarette use, highlighting concerns about acute nicotine toxicity.

E-cigarette exposure calls were compared to conventional tobacco cigarette exposure calls to assess their relative safety, but the overall impact of e-cigarettes on public health remains uncertain, especially given the lack of regulation and potential access for minors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014. Chatham-Stephens, K., Law, R., Taylor, E., et al.[2022]

A systematic review of 44 studies, including 31 randomized controlled trials, found that alternative tobacco and nicotine products like electronic cigarettes (EC), smokeless tobacco, and nicotine replacement therapy (NRT) can moderately reduce daily cigarette consumption and assist in smoking cessation with fewer adverse events.

The evidence supports the potential role of these products in tobacco harm reduction, but further research is needed to evaluate their long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Alternative Tobacco and Nicotine Products for Smoking Reduction and Cessation: A Systematic Review. Zakiyah, N., Purwadi, FV., Insani, WN., 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]

Electronic cigarettes are marketed as safe alternatives to traditional tobacco products, but there are growing concerns about their potential negative health impacts.

There is a call for regulatory measures on the manufacturing and marketing of e-cigarettes, as well as further research to better understand their health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes: health risks and workplace policy. Phillips, JA.[2017]

A significant majority of smokers and recent ex-smokers in the UK (57.3% for e-cigarettes and 63.4% for nicotine replacement therapy) perceive these alternatives as less harmful than traditional smoking, indicating a general awareness of their reduced risk.

However, misconceptions persist, particularly among those who have never vaped and those with inaccurate knowledge about nicotine, leading to concerns about e-cigarettes related to research gaps, regulation, and chemical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harm perceptions of e-cigarettes and other nicotine products in a UK sample. Wilson, S., Partos, T., McNeill, A., et al.[2023]

References

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

E-cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: randomized controlled trial. [2022]

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

E-cigarettes and nicotine abstinence: a meta-analysis of randomised controlled trials. [2022]

3. Greece pubmed.ncbi.nlm.nih.gov

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. [2022]

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

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Participant Experiences of a Quit Smoking Attempt Through Either Nicotine Replacement Therapy (NRT) Methods or the Use of an E-cigarette. [2022]

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

Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014. [2022]

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

Effectiveness and Safety Profile of Alternative Tobacco and Nicotine Products for Smoking Reduction and Cessation: A Systematic Review. [2023]

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. England pubmed.ncbi.nlm.nih.gov

Retrospective review of nicotine exposures in California from 2012 to 2018 and analysis of the impacts of e-cigarette regulations. [2021]

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

Electronic cigarettes: health risks and workplace policy. [2017]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of electronic cigarette use (vaping) topography and estimation of liquid consumption: implications for research protocol standards definition and for public health authorities' regulation. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Harm perceptions of e-cigarettes and other nicotine products in a UK sample. [2023]