E-Cigarettes and NRT for Tobacco Smoking

Not currently recruiting at 1 trial location

Overseen By Justin McClendon

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help people living with HIV/AIDS in South Africa reduce cigarette smoking. Researchers compare the effectiveness of e-cigarettes (EC) and nicotine replacement therapy (such as patches and lozenges), both supported by phone counseling and helpful text messages. The goal is to determine which method best reduces smoking and improves health over time. This trial may suit those who smoke at least five cigarettes a day, speak Afrikaans, Xhosa, or English, and are interested in reducing smoking but not necessarily quitting. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore these innovative smoking reduction methods.

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.

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

Research has shown that nicotine replacement therapy (NRT), such as patches and lozenges, is generally safe for most people. Most studies have found that side effects are usually mild, with common ones including skin irritation from patches and mouth soreness or ulcers from lozenges. These side effects are not serious for most users.

The safety of electronic cigarettes (EC) remains less certain. Fewer studies exist on ECs compared to NRT. However, ECs are often used as an alternative to smoking, and their safety profile might differ from traditional smoking.

As this trial is in its early stages, it primarily aims to understand safety in humans. Early trials often help researchers learn more about possible side effects and how well people tolerate the treatments. Prospective participants should keep this in mind. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using electronic cigarettes (ECs) and nicotine replacement therapy (NRT) for smoking cessation because they offer potentially more flexible and personalized options for quitting. Unlike traditional methods like nicotine patches or gum, ECs provide a similar hand-to-mouth action as smoking, which might help satisfy habitual cravings. The NRT arm combines daily patches and lozenges with phone counseling and text reminders, providing a comprehensive support system that isn't typically available with standard treatments. Additionally, integrating technology through ecological momentary interventions (EMI) and assessments (EMA) could enhance real-time support and monitoring, potentially improving success rates for those looking to quit smoking.

What evidence suggests that this trial's treatments could be effective for reducing cigarette use among people living with HIV/AIDS?

Research has shown that e-cigarettes, which participants in this trial may receive, can help people quit smoking. Some studies suggest e-cigarettes might be more effective than methods like nicotine patches or lozenges. However, other studies find that people using e-cigarettes may quit less often than those who don't use them. Participants in this trial may also receive Nicotine Replacement Therapy (NRT), including nicotine patches and lozenges, which help control cravings and withdrawal symptoms, potentially easing the quitting process for some. Evidence also shows that combining these methods with counseling, included in this trial, can improve the chances of quitting smoking. It's important to consider both options and choose what might work best. ^{6 7 8 9 10}

Who Is on the Research Team?

Omar El-Shahawy

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Fogarty International Center of the National Institute of Health

Collaborator

Trials

157

Recruited

172,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2300229

Population-Based Disease Odds for E-Cigarettes and Dual ... Current dual use was associated with 20 to 40% higher odds of disease than smoking, suggesting increased overall population risks for e- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4752870/

E-cigarettes and smoking cessation in real-world ... As currently being used, e-cigarettes are associated with significantly less quitting among smokers. According to the results of our systematic review and meta- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9232181/

Electronic Cigarettes: Are They Smoking Cessation Aids or ... On the contrary, e-cig use has been shown to be more effective in smoking cessation than other nicotine replacement therapies [12], and there ...

4. nature.com nature.com/articles/s41598-022-26417-2

Part one: abuse liability of Vuse Solo (G2) electronic ... Product liking, intent to use again, suppression of urge to smoke, and nicotine PK were lower after use of Vuse Solo compared to cigarettes and ...

5. truthinitiative.org truthinitiative.org/sites/default/files/media/files/2024/06/Truth_E-Cigarette%20Factsheet_5.23.2024.pdf

E-Cigarettes 9 Randomized control trials provide growing evidence that e-cigarettes with nicotine can increase quitting rates when compared to nicotine.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493148/

Nicotine Replacement Therapy - StatPearls - NCBI Bookshelf NRT use is strongly recommended to be initiated either 1 to 2 weeks before quitting or immediately after discontinuing cigarette use. Bupropion, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2917405/

Adverse events associated with nicotine replacement therapy ... Almost all studies demonstrated localized irritation related to NRT use, skin irritation with the use of NRT patch and mouth soreness and ulcerations with ...

8. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Adverse-events-associated-with-nicotine-replacement-therapy-NRT-for-smoking-cessation,65973,0,2.html

Adverse events associated with nicotine replacement ... Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence.

9. cancer.org cancer.org/cancer/risk-prevention/tobacco/guide-quitting-smoking/nicotine-replacement-therapy.html

Nicotine Replacement Therapy to Help You Quit Tobacco Many studies have shown using NRT can almost double the chances of quitting smoking. It hasn't been studied as much for quitting smokeless ...

10. fda.gov fda.gov/media/167599/download

Developing Nicotine Replacement Therapy Drug Products The use of other smoking cessation drugs and any non-study nicotine or tobacco products should be recorded. At a minimum, exhaled breath carbon monoxide (CO) ...